Medical devices, involving those that are implanted within patients, are increasingly likely to be targeted by hackers and could pose a nightmare scenario if providers do not take measures to improve their defenses.
“The issue with security is that hackers always follow the path of least resistance,” claims Sam Rehman, the chief technology officer at security vendor Arxan, which serves multiple industries and has a large footprint in healthcare.
Like several other security vendors, Rehman says providers require conducting a comprehensive risk assessment and fixing vulnerabilities. In healthcare, medical devices security is a hot topic and for great reason, because providers mostly have hundreds if not thousands of devices in their facilities.
But providers also require increasing security levels for devices that are implanted in patients, and that is because several of those devices have wireless capabilities that enable hackers to interfere with them, Rehman says.
For instance, physicians can utilize hand-held medical devices to wirelessly collect data and even update an implant, for example to change device settings on insulin pumps, pacemakers and other devices. Although, a hacker in a hospital can do the same thing, which represents a potential risk to patient safety, Rehman cautions.
Many hackers might not need to intentionally cause harm, but others will do what someone pays them to do, which could involve causing injury to patients. Rehman says monetary motivation, particularly through blackmail, could rise as a potential risk.
Such hacking could involve efforts to affect the share price of a device manufacturer. Rehman says stock price manipulation could provide another financial motive for hacking. For imstance, if one person can make money by paying another person to cause harm, the instigator can make money when a company’s stock price falls.
A scenario similar to this has already occurred. Previously this year, the Food and Drug Administration confirmed cybersecurity vulnerabilities in St. Jude Medical’s implantable cardiac devices and its Merlin@home transmitter. The vulnerabilities were originally declared by an investment group that threatened to make money by selling its stock short.
St. Jude Medical devices, the FDA stated, could be hacked by outsiders, leading to injury or death, and St. Jude’s share price quickly dropped by 10% as the company scrambled to make fixes. “If someone can make money, this absolutely will happen,” Rehman assumes.
Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts
Sunday, July 9, 2017
Saturday, May 13, 2017
Deep learning computer network excels at verification of breast cancer biopsy slides
Researchers have established a deep learning computer network that is highly precise and accurate in verifying whether invasive forms of breast cancer are present in whole biopsy slides.
A research team supervised by Case Western Reserve University published results of their research in Scientific Reports, detailing their deep learning computer network approach.
The research first involved training the network by downloading 400 biopsy images from several hospitals and then presenting the network with 200 images from The Cancer Genome Atlas and University Hospitals Cleveland Medical Center. Deep learning computer network excels at verification of breast cancer biopsy slides.
In accordance to Anant Madabushi, professor of biomedical engineering at Case Western Reserve and co-author of the study, the network scored 100% precision in determining the presence or absence of cancer on whole slides.
“This is a research with 600 patients, so it is fairly robust,” claims Madabushi, who also directs Case Western Reserve’s Center of Computational Imaging and Personalized Diagnostics. “And there were many human-machine comparisons done.”
In fact, compared with the analyses of 4 pathologists, the machine was more consistent and accurate, Madabushi asserts.
“Pathologists are highly busy, and we are talking about microscopic-level detail in these tissue slides. So, obviously, for them to go in and pick out every cell of cancer wasn’t tenable. There just was not enough time for them to be capable to sit down and manually do that,” adds Madabushi. “The network initiated to get more sophisticated, more granular and more accurate than the pathologists.”
Previous month, the Food and Drug Administration approved the marketing of the Philips IntelliSite Pathology Solution, the first whole slide imaging (WSI) system that enables review and interpretation of digital surgical pathology slides prepared from biopsied tissue. The system enables pathologists to read tissue slides digitally to make diagnoses, instead of looking straightly at a tissue sample mounted on a glass slide under a conventional light microscope.
In accordance to Madabushi, this is the first time the FDA has permitted the marketing of a WSI system for these purposes, which he says is a huge milestone for pathology. “A pathologist can look at an image of a slide on their computer monitor, and that is equivalent to the pathologist looking at a slide under their microscope,” he points out. “That means digital pathology—the digitization of slides—can now be utilized for primary diagnosis by a pathologist. That is a game changer.”
He considers that as pathologists increasingly adopt digital pathology there will be “an even greater need for software and analytics like the one we released in this paper.” Finally, Madabushi emphasizes that the FDA’s clearance of the Philips system “opens the door to an entire market for the analysis of digital pathology slide images.”
A research team supervised by Case Western Reserve University published results of their research in Scientific Reports, detailing their deep learning computer network approach.
The research first involved training the network by downloading 400 biopsy images from several hospitals and then presenting the network with 200 images from The Cancer Genome Atlas and University Hospitals Cleveland Medical Center. Deep learning computer network excels at verification of breast cancer biopsy slides.
In accordance to Anant Madabushi, professor of biomedical engineering at Case Western Reserve and co-author of the study, the network scored 100% precision in determining the presence or absence of cancer on whole slides.
“This is a research with 600 patients, so it is fairly robust,” claims Madabushi, who also directs Case Western Reserve’s Center of Computational Imaging and Personalized Diagnostics. “And there were many human-machine comparisons done.”
In fact, compared with the analyses of 4 pathologists, the machine was more consistent and accurate, Madabushi asserts.
“Pathologists are highly busy, and we are talking about microscopic-level detail in these tissue slides. So, obviously, for them to go in and pick out every cell of cancer wasn’t tenable. There just was not enough time for them to be capable to sit down and manually do that,” adds Madabushi. “The network initiated to get more sophisticated, more granular and more accurate than the pathologists.”
Previous month, the Food and Drug Administration approved the marketing of the Philips IntelliSite Pathology Solution, the first whole slide imaging (WSI) system that enables review and interpretation of digital surgical pathology slides prepared from biopsied tissue. The system enables pathologists to read tissue slides digitally to make diagnoses, instead of looking straightly at a tissue sample mounted on a glass slide under a conventional light microscope.
In accordance to Madabushi, this is the first time the FDA has permitted the marketing of a WSI system for these purposes, which he says is a huge milestone for pathology. “A pathologist can look at an image of a slide on their computer monitor, and that is equivalent to the pathologist looking at a slide under their microscope,” he points out. “That means digital pathology—the digitization of slides—can now be utilized for primary diagnosis by a pathologist. That is a game changer.”
He considers that as pathologists increasingly adopt digital pathology there will be “an even greater need for software and analytics like the one we released in this paper.” Finally, Madabushi emphasizes that the FDA’s clearance of the Philips system “opens the door to an entire market for the analysis of digital pathology slide images.”
Thursday, April 20, 2017
Modern technology could change how pathologists examine tissue samples
The days of pathologists viewing tissue samples on glass slides under a microscope might be drawing to an end. New technology granted marketing rights on the day of April 12 by the Food and Drug Administration enables the review and interpretation of digital surgical pathology slides prepared from biopsied tissue.
Philips Medical Systems got the FDA approval for its Philips IntelliSite Pathology Solution, or PIPS.
“The system enables pathologists to view and read tissue samples digitally in case to make diagnoses, instead of looking directly at a tissue sample mounted on a glass slide under a conventional light microscope,” Albert Gutierrez, director of FDA’s Office of In Vitro Diagnostics and Radiological Health stated.
The approach has the possibility to bring efficiencies to healthcare agencies by digitizing pathology procedures that have relied extensively on physical storage of specimens.
“Because the system digitizes slides that would otherwise be stored in physical files, it also gives a streamlined slide storage and retrieval system that may finally assist to make critical health information available to pathologists, other healthcare professionals and sufferers faster,” Gutierrez states.
Pathologists are scientists practicing the research of disease and making diagnoses by viewing tissues, organs, body fluids and autopsies. In contrast to the present practice of mounting tissue on a slide and applying stain to ease viewing and evaluation, PIPS scans and digitizes conventional slides with resolution of as much as 400 times magnification.
By utilizing PIPS, pathologists yet must put a tissue sample on a slide, but then a digital image is taken, enabling the corresponding increase in resolution.
When slides are digitized, they are available for query in a database, as opposed to current practices of slides placed in a physical filing system that the pathologist thumbs through to find the right slide.
Readings, the FDA warns, do not change because the tissue samples are on a digital platform.
In clearing PIPS to enter the market, FDA utilized a recently adopted accelerated review and decision procedure that quickens approval of new low or moderate risk innovations not substantially equivalent to already-marketed devices in an effort to speed medical innovation.
FDA approval came after the organization evaluated data from about 2,000 pathology cases using tissues from several parts of the body. Results discovered that diagnoses made using PIPS images were comparable to findings using glass slides. Risks of utilizing PIPS are similar to those of traditional microscope findings.
Philips Medical Systems got the FDA approval for its Philips IntelliSite Pathology Solution, or PIPS.
“The system enables pathologists to view and read tissue samples digitally in case to make diagnoses, instead of looking directly at a tissue sample mounted on a glass slide under a conventional light microscope,” Albert Gutierrez, director of FDA’s Office of In Vitro Diagnostics and Radiological Health stated.
The approach has the possibility to bring efficiencies to healthcare agencies by digitizing pathology procedures that have relied extensively on physical storage of specimens.
“Because the system digitizes slides that would otherwise be stored in physical files, it also gives a streamlined slide storage and retrieval system that may finally assist to make critical health information available to pathologists, other healthcare professionals and sufferers faster,” Gutierrez states.
Pathologists are scientists practicing the research of disease and making diagnoses by viewing tissues, organs, body fluids and autopsies. In contrast to the present practice of mounting tissue on a slide and applying stain to ease viewing and evaluation, PIPS scans and digitizes conventional slides with resolution of as much as 400 times magnification.
By utilizing PIPS, pathologists yet must put a tissue sample on a slide, but then a digital image is taken, enabling the corresponding increase in resolution.
When slides are digitized, they are available for query in a database, as opposed to current practices of slides placed in a physical filing system that the pathologist thumbs through to find the right slide.
Readings, the FDA warns, do not change because the tissue samples are on a digital platform.
In clearing PIPS to enter the market, FDA utilized a recently adopted accelerated review and decision procedure that quickens approval of new low or moderate risk innovations not substantially equivalent to already-marketed devices in an effort to speed medical innovation.
FDA approval came after the organization evaluated data from about 2,000 pathology cases using tissues from several parts of the body. Results discovered that diagnoses made using PIPS images were comparable to findings using glass slides. Risks of utilizing PIPS are similar to those of traditional microscope findings.
Saturday, January 14, 2017
FDA, IBM Watson Health partners to investigate application of blockchain technology
The Food and Drug Administration (FDA) and IBM Watson Health are establishing a partnership to examine potential ways that blockchain technology can be utilized in healthcare.
The agency and IBM subsidiary have signed a 2-year contract that will enable them to jointly investigate ways to use the emerging technology. Initial attempts will concentrate on oncology-related data.
Proponents of blockchain technology consider that it could have wide applicability in healthcare. It enables the collection of information from a variety of sources, and keeps an audit trail of transactions, thus developing accountability and transparency in the data exchange procedure.
The FDA and IBM Watson Health will look at ways blockchain technology can enable healthcare entities to work together with more trust. They consider the technology can support the exchange of “owner-mediated data from various sources,” like electronic health records (EHRs), clinical trials, genomic data and information collected from presently untapped information sources, like mobile devices, wearable’s and Internet of Thing devices.
Initial attempts of the partners will focus on how a blockchain framework can help public health efforts.
“One aspect of the role of FDA as a regulatory science agency is to conduct research that informs the development of latest tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products,” claimed Sean Khozin, MD, senior medical officer, Office of hematology and oncology products, Center for Drug Evaluation and Research at the FDA. “By studying blockchain technology, the FDA is investing to the advancement of clinical research by testing novel frameworks for protective exchange of worthy patient-level health data at scale.”
It is this wider view of patient data that will help researchers in making better research initiatives, states Shahram Ebadollahi, vice president for innovations and chief science officer for IBM Watson Health.
“One of the problems in research is the availability of a longitudinal record of patient information that gives a 360 degree view of the patient,” Ebadollahi claims. “There is been no central place to put the data. Blockchain provides the chance to produce value and outcomes on the distributed ledger, interoperability, privacy and security, while putting the sufferer in the center.
The initiative will be constructed on IBM’s work in establishing and advancing blockchain technology, Ebadollahi adds. For instance, IBM is a founding member and key contributor to the Linux Foundation's Hyperledger project, a key underpinning for blockchain.
Under the research contract, the FDA will work straightly with IBM Watson Health. It will leverage the agency’s technical and organizational resources from its Information Exchange and Data Transformation (INFORMED) initiative. “That is an FDA big data initiative created to support novel scientific research using huge clinical trial datasets and emerging pipelines of data from sources like electronic medical record systems, biometric monitoring devices and wearable technologies,” Khozin asserts.
IBM Watson Health and the FDA plan to share earlier or initial research findings by the end of 2017 year, he adds.
The federal agency observes a variety of potential benefits from inquiring how blockchain could be used in healthcare and focusing efforts on indicating its value in specific use cases, Khozin adds.
“Huge amounts of patient data are generated in the public health sector,” he notes. “This data has the potential to assist researchers to develop more effective and safer treatments for sufferers, particularly in life-threatening disease areas such as cancer, which has observed a huge rise in the use of personalized and targeted therapies for disease treatment.
“Blockchain technology has the potential to support secure exchange of huge volumes of data while ensuring sufferer privacy and maintaining data integrity,” he adds. “These are crucial features of a scalable data exchange ecosystem that can support high-quality research while protecting against breaches of sensitive patient-level information.”
The initiative offers IBM and its Watson Health division a chance to demonstrate whether blockchain can live up to the hype that is growing around its potential to meet vexing problems in healthcare IT.
As the promise of blockchain in healthcare becomes more obvious, IBM will work to define and develop the technological solution for a scalable and decentralized information sharing ecosystem, Ebadollahi says.
“The healthcare industry is undergoing important modifications because of the vast amounts of disparate data being generated. Blockchain technology gives a greatly secure, decentralized framework for information sharing that will accelerate innovation throughout the industry,” he claims.
The initial focus on oncology with the FDA makes sense because it is “a domain to test the technology and observe how it maps to several use cases,” he further adds. “We are looking to build a patient-mediated electronic health data exchange. There are several reasons for doing this, chief among them the problem of trust—can you put faith in the data you are looking at. With blockchain, we feel it can be a remedy for that.
“We are very excited about this, and there is no better partner for us than the FDA,” Ebadollahi claims. “They know about our information of blockchain, and this offers us a matter of mutual interest from which the public can gain benefit.”
The agency and IBM subsidiary have signed a 2-year contract that will enable them to jointly investigate ways to use the emerging technology. Initial attempts will concentrate on oncology-related data.
Proponents of blockchain technology consider that it could have wide applicability in healthcare. It enables the collection of information from a variety of sources, and keeps an audit trail of transactions, thus developing accountability and transparency in the data exchange procedure.
The FDA and IBM Watson Health will look at ways blockchain technology can enable healthcare entities to work together with more trust. They consider the technology can support the exchange of “owner-mediated data from various sources,” like electronic health records (EHRs), clinical trials, genomic data and information collected from presently untapped information sources, like mobile devices, wearable’s and Internet of Thing devices.
Initial attempts of the partners will focus on how a blockchain framework can help public health efforts.
“One aspect of the role of FDA as a regulatory science agency is to conduct research that informs the development of latest tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products,” claimed Sean Khozin, MD, senior medical officer, Office of hematology and oncology products, Center for Drug Evaluation and Research at the FDA. “By studying blockchain technology, the FDA is investing to the advancement of clinical research by testing novel frameworks for protective exchange of worthy patient-level health data at scale.”
It is this wider view of patient data that will help researchers in making better research initiatives, states Shahram Ebadollahi, vice president for innovations and chief science officer for IBM Watson Health.
“One of the problems in research is the availability of a longitudinal record of patient information that gives a 360 degree view of the patient,” Ebadollahi claims. “There is been no central place to put the data. Blockchain provides the chance to produce value and outcomes on the distributed ledger, interoperability, privacy and security, while putting the sufferer in the center.
The initiative will be constructed on IBM’s work in establishing and advancing blockchain technology, Ebadollahi adds. For instance, IBM is a founding member and key contributor to the Linux Foundation's Hyperledger project, a key underpinning for blockchain.
Under the research contract, the FDA will work straightly with IBM Watson Health. It will leverage the agency’s technical and organizational resources from its Information Exchange and Data Transformation (INFORMED) initiative. “That is an FDA big data initiative created to support novel scientific research using huge clinical trial datasets and emerging pipelines of data from sources like electronic medical record systems, biometric monitoring devices and wearable technologies,” Khozin asserts.
IBM Watson Health and the FDA plan to share earlier or initial research findings by the end of 2017 year, he adds.
The federal agency observes a variety of potential benefits from inquiring how blockchain could be used in healthcare and focusing efforts on indicating its value in specific use cases, Khozin adds.
“Huge amounts of patient data are generated in the public health sector,” he notes. “This data has the potential to assist researchers to develop more effective and safer treatments for sufferers, particularly in life-threatening disease areas such as cancer, which has observed a huge rise in the use of personalized and targeted therapies for disease treatment.
“Blockchain technology has the potential to support secure exchange of huge volumes of data while ensuring sufferer privacy and maintaining data integrity,” he adds. “These are crucial features of a scalable data exchange ecosystem that can support high-quality research while protecting against breaches of sensitive patient-level information.”
The initiative offers IBM and its Watson Health division a chance to demonstrate whether blockchain can live up to the hype that is growing around its potential to meet vexing problems in healthcare IT.
As the promise of blockchain in healthcare becomes more obvious, IBM will work to define and develop the technological solution for a scalable and decentralized information sharing ecosystem, Ebadollahi says.
“The healthcare industry is undergoing important modifications because of the vast amounts of disparate data being generated. Blockchain technology gives a greatly secure, decentralized framework for information sharing that will accelerate innovation throughout the industry,” he claims.
The initial focus on oncology with the FDA makes sense because it is “a domain to test the technology and observe how it maps to several use cases,” he further adds. “We are looking to build a patient-mediated electronic health data exchange. There are several reasons for doing this, chief among them the problem of trust—can you put faith in the data you are looking at. With blockchain, we feel it can be a remedy for that.
“We are very excited about this, and there is no better partner for us than the FDA,” Ebadollahi claims. “They know about our information of blockchain, and this offers us a matter of mutual interest from which the public can gain benefit.”
Saturday, December 31, 2016
FDA not planning to establish guidance on CDS in 2017
Software developers who were expecting that the Food and Drug Administration’s Center for Devices and Radiological Health might release draft guidance on clinical decision support (CDS) software have once again been disappointed.
In accordance to the FDA, its Center for Devices and Radiological Health (CDRH) is considering establishing a variety of guidance in fiscal year 2017, involving its so-called “A-List” documents, those that the organization intends to publish between the time period of Oct. 1, 2016 and Sept. 30, 2017. Although, draft CDS guidance isn’t among CDRH’s priorities going into next year.
Among those disappointed that Clinical Decision Support (CDS) is not on the agency’s near-term agenda is Bradley Merrill Thompson, general counsel for the Clinical Decision Support (CDS) Coalition, which reflects software developers, providers, healthcare payers and medical device manufacturers.
“For the last 2 years, CDRH has placed in the category A priority list draft guidance on clinical decision support software. It is not on the list this year, despite the fact that CDRH hasn’t released the draft guidance,” says Thompson.
Thompson asserts that industry has been waiting for FDA guidance on CDS since the year of 2011. When it comes to software development, 5 years is an eternity, he asserts.
Without clarification on how the FDA plans to regulate CDS, the software category will sustain to be a gray area, leaving developers struggling to get funding and to put together business plans that precisely depict the expected regulatory path for their products, Thompson explains.
Survey results issued earlier this year by the CDS Coalition indicated that one-third of developers reported having to abandon CDS product development efforts due to the uncertainty over FDA regulations. Of those who pressed ahead despite the uncertainty, nearly two-thirds encountered significant delays.
In a written statement, an FDA spokesperson claimed that the agency is “carefully evaluating” the 21st Century Cures Act that was approved by Congress and signed into law earlier this month by President Obama, and it is “exploring all possible options for executing the responsibilities, involving the provision for clinical decision software, that we have been charged with under the new law.”
Thompson considers the FDA removed CDS from CDRH’s FY17 list of guidance documents because the agency plans to re-evaluate the requirement for CDS guidance in connection with implementing the 21st Century Cures Act.
“That legislation, in section 3060, adds the criterion that to be FDA regulated, Clinical Decision Support (CDS) software must not be transparent. In this context, transparent means that the doctor user can’t see through the software to the underlying sufferer data and the clinical logic applied by the software, such that the physician isn’t required to rely on the software,” claims Thompson. “My hope is that in connection with the legislation, FDA proceeds with the guidance, which is more significant now than ever before.”
Particularly, the CDS Coalition would like to comprehend how the agency plans to enforce the transparency concept. “The statute is very useful, but it will be very significant for FDA to express the agency’s views on how the language is to be interpreted and applied,” adds Thompson.
“I’ll be very anxious to see the FDA’s plans for implementing the Cures legislation,” he summarizes. “I certainly expect that they plan to proceed with this much required guidance.”
In accordance to the FDA, its Center for Devices and Radiological Health (CDRH) is considering establishing a variety of guidance in fiscal year 2017, involving its so-called “A-List” documents, those that the organization intends to publish between the time period of Oct. 1, 2016 and Sept. 30, 2017. Although, draft CDS guidance isn’t among CDRH’s priorities going into next year.
Among those disappointed that Clinical Decision Support (CDS) is not on the agency’s near-term agenda is Bradley Merrill Thompson, general counsel for the Clinical Decision Support (CDS) Coalition, which reflects software developers, providers, healthcare payers and medical device manufacturers.
“For the last 2 years, CDRH has placed in the category A priority list draft guidance on clinical decision support software. It is not on the list this year, despite the fact that CDRH hasn’t released the draft guidance,” says Thompson.
Thompson asserts that industry has been waiting for FDA guidance on CDS since the year of 2011. When it comes to software development, 5 years is an eternity, he asserts.
Without clarification on how the FDA plans to regulate CDS, the software category will sustain to be a gray area, leaving developers struggling to get funding and to put together business plans that precisely depict the expected regulatory path for their products, Thompson explains.
Survey results issued earlier this year by the CDS Coalition indicated that one-third of developers reported having to abandon CDS product development efforts due to the uncertainty over FDA regulations. Of those who pressed ahead despite the uncertainty, nearly two-thirds encountered significant delays.
In a written statement, an FDA spokesperson claimed that the agency is “carefully evaluating” the 21st Century Cures Act that was approved by Congress and signed into law earlier this month by President Obama, and it is “exploring all possible options for executing the responsibilities, involving the provision for clinical decision software, that we have been charged with under the new law.”
Thompson considers the FDA removed CDS from CDRH’s FY17 list of guidance documents because the agency plans to re-evaluate the requirement for CDS guidance in connection with implementing the 21st Century Cures Act.
“That legislation, in section 3060, adds the criterion that to be FDA regulated, Clinical Decision Support (CDS) software must not be transparent. In this context, transparent means that the doctor user can’t see through the software to the underlying sufferer data and the clinical logic applied by the software, such that the physician isn’t required to rely on the software,” claims Thompson. “My hope is that in connection with the legislation, FDA proceeds with the guidance, which is more significant now than ever before.”
Particularly, the CDS Coalition would like to comprehend how the agency plans to enforce the transparency concept. “The statute is very useful, but it will be very significant for FDA to express the agency’s views on how the language is to be interpreted and applied,” adds Thompson.
“I’ll be very anxious to see the FDA’s plans for implementing the Cures legislation,” he summarizes. “I certainly expect that they plan to proceed with this much required guidance.”
Wednesday, December 28, 2016
FDA expands the approved use of Continuous Glucose Monitoring System
The Food and Drug Administration (FDA) has expanded the approved use of Dexcom’s G5 Mobile Continuous Glucose Monitoring system or CGM system, which could instantly replace fingerstick blood glucose testing for diabetes treatment decisions in diabetic sufferers 2 years of age and older.
In accordance to the regulatory agency, it is the 1st FDA-approved Continuous Glucose Monitoring system that can be utilized to make diabetes treatment decisions without confirmation with a conventional fingerstick test. Initially, the Dexcom system was cleared to complement—not replace—fingerstick testing for diabetes treatment decisions.
“The FDA works really hard to assist ensure that novel technologies, which can decrease the burden of daily disease management, are safe and precise," stated Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. "However this system still requires calibration with 2 daily fingersticks, it removes the requirement for any extra fingerstick blood glucose testing in order to make treatment decisions.
“This might permit some sufferers to handle their disease more comfortably and may motivate them to have routine dialogue with their healthcare providers about the use of real-time continuous glucose monitoring in diabetes management," further added Gutierrez.
Dexcom’s G5 Mobile CGM System uses a small sensor wire inserted merely below the skin that continuously measures and monitors glucose levels, sending real-time results wirelessly every 5 minutes to a dedicated receiver and a compatible mobile device—like the Apple iPhone—running a mobile app. Additionally, alarms and alerts notify consumers when there are glucose levels above or below user-set thresholds.
While the system calculates glucose in fluid under the skin that must be calibrated almost 2 times each day using blood obtained from fingerstick tests, Nicholas Argento, MD, an endocrinologist, claims that extra daily fingerstick blood tests are generally no longer essential because unlike other CGS systems, results from the device can now be used straightly by sufferers to make diabetes treatment decisions without confirmation from a traditional fingerstick test.
“We have seen CGM come from something that was sort of novel and experimental to now actually being the standard of care,” further adds Argento, who has Type 1 diabetes and personally uses the Dexcom Continuous Glucose Monitoring system. “What this system does is reduce the number of fingersticks and increases their level of blood sugar control by motivating sufferers to take action in a safe, discrete, accurate, and timely way.”
Argento points out that in addition to individuals with Type 1 diabetes there are an increasing number of patients with Type 2 diabetes using the Dexcom G5 Mobile Continuous Glucose Monitoring System. He also makes the point that consumers of the system are capable to designate “followers” like family members with whom they can share the CGM data through the app.
“This is a key benefit in specific for parents with young kids and teenagers that are now starting to drive. The technology permits caregivers to have their back and serve as their backups,” in accordance to Argento, who serves as the medical advisor to the diabetes program at the Howard County General Hospital, a Johns Hopkins System hospital in Columbia, Md.
In making its decision to expand the approved use of the CGM system, the FDA verified data from 2 clinical studies during which there were no critical adverse events were reported, according to the regulatory agency.
Nevertheless, the FDA released a written statement that “risks associated with use of the system might involve hypoglycemia or hyperglycemia in cases where data provided by the device is wrong and utilized to make treatment decisions or where hardware or set-up issues disable alarms and alerts, as well as skin irritation or redness over the device’s adhesive patch.”
Moreover, the agency cautioned users that the system “must be calibrated utilizing a fingerstick blood sample at least once every twelve hours and that taking any medications containing acetaminophen while wearing the system might wrongly raise glucose readings.”
In accordance to the regulatory agency, it is the 1st FDA-approved Continuous Glucose Monitoring system that can be utilized to make diabetes treatment decisions without confirmation with a conventional fingerstick test. Initially, the Dexcom system was cleared to complement—not replace—fingerstick testing for diabetes treatment decisions.
“The FDA works really hard to assist ensure that novel technologies, which can decrease the burden of daily disease management, are safe and precise," stated Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. "However this system still requires calibration with 2 daily fingersticks, it removes the requirement for any extra fingerstick blood glucose testing in order to make treatment decisions.
“This might permit some sufferers to handle their disease more comfortably and may motivate them to have routine dialogue with their healthcare providers about the use of real-time continuous glucose monitoring in diabetes management," further added Gutierrez.
Dexcom’s G5 Mobile CGM System uses a small sensor wire inserted merely below the skin that continuously measures and monitors glucose levels, sending real-time results wirelessly every 5 minutes to a dedicated receiver and a compatible mobile device—like the Apple iPhone—running a mobile app. Additionally, alarms and alerts notify consumers when there are glucose levels above or below user-set thresholds.
While the system calculates glucose in fluid under the skin that must be calibrated almost 2 times each day using blood obtained from fingerstick tests, Nicholas Argento, MD, an endocrinologist, claims that extra daily fingerstick blood tests are generally no longer essential because unlike other CGS systems, results from the device can now be used straightly by sufferers to make diabetes treatment decisions without confirmation from a traditional fingerstick test.
“We have seen CGM come from something that was sort of novel and experimental to now actually being the standard of care,” further adds Argento, who has Type 1 diabetes and personally uses the Dexcom Continuous Glucose Monitoring system. “What this system does is reduce the number of fingersticks and increases their level of blood sugar control by motivating sufferers to take action in a safe, discrete, accurate, and timely way.”
Argento points out that in addition to individuals with Type 1 diabetes there are an increasing number of patients with Type 2 diabetes using the Dexcom G5 Mobile Continuous Glucose Monitoring System. He also makes the point that consumers of the system are capable to designate “followers” like family members with whom they can share the CGM data through the app.
“This is a key benefit in specific for parents with young kids and teenagers that are now starting to drive. The technology permits caregivers to have their back and serve as their backups,” in accordance to Argento, who serves as the medical advisor to the diabetes program at the Howard County General Hospital, a Johns Hopkins System hospital in Columbia, Md.
In making its decision to expand the approved use of the CGM system, the FDA verified data from 2 clinical studies during which there were no critical adverse events were reported, according to the regulatory agency.
Nevertheless, the FDA released a written statement that “risks associated with use of the system might involve hypoglycemia or hyperglycemia in cases where data provided by the device is wrong and utilized to make treatment decisions or where hardware or set-up issues disable alarms and alerts, as well as skin irritation or redness over the device’s adhesive patch.”
Moreover, the agency cautioned users that the system “must be calibrated utilizing a fingerstick blood sample at least once every twelve hours and that taking any medications containing acetaminophen while wearing the system might wrongly raise glucose readings.”
Monday, December 19, 2016
Startup-led team succeeds in FDA opioid overdose app contest
The Food and Drug Administration has chosen a team supervised by a small Venice, Calif.-based startup as the winner of an industry challenge to establish a mobile app to assist connect opioid consumers experiencing an overdose with nearby carriers of the drug naloxone for emergency treatment. Startup-led team has got victory in FDA opioid overdose app contest.
The OD Help app, established by Team PwrdBy, beat 44 other submissions to take home the cash prize of $40,000, claims Peter Lurie, MD, the FDA’s associate commissioner for public health strategy and analysis. Startup-led team has got victory in FDA opioid overdose app contest.
“OD Help is a convenient, easy-to-use mobile app created to connect potential opioid overdose victims with a crowd-sourced network of naloxone carriers,” wrote Lurie in a December 15 blog, further adding that the app “can conveniently be tailored for use in rural or urban regions by expanding or contracting the radius within which naloxone carriers are sought.”
In the month of September, the FDA inaugurated the Naloxone App Competition in an attempt to tackle the dramatic increase in the number of U.S. opioid overdose deaths, several of which could be ignored if people experiencing an overdose had immediately got the life-saving medication, in accordance to the regulatory agency. Although, until now, no app has been available to connect those carrying naloxone with nearby opioid overdose victims.
Among other significant features, OD Help has an optional interface with a breathing monitor to track when a victim’s breathing rate is very low, a symptom of an opioid overdose. “Therefore, if the victim is alone and not able to call for help, OD Help will track the diminished breathing and alert a naloxone carrier of the potential overdose,” Lurie stated.
Other characteristics of the FDA opioid overdose app involve: just alerting people in one’s support network and permitting naloxone carriers to disable alerts when they are not able to respond, as well as giving instructions on how to rightly diagnose an overdose/administer naloxone and contact emergency medical services when assistance is needed.
Lurie asserts that OD Help “has the potential to make a real difference in the fight against opioid overdose.” Representatives from PwrdBy weren’t instantly available for comment.
The FDA hosted a code-a-thon October 19 and 20 at its White Oak campus in Silver Spring, Md., to establish the concepts and initial prototypes. More than 100 people participated either in-person or virtually in the 2-day event.
The rules of the competition needed participants to submit a video of a functional app prototype along with a comprehensive summary of their concept for a crowd-sourced mobile phone app that could assist to accelerate delivery of naloxone to a person experiencing an overdose. The video of the OD Help app can be viewed here.
Wednesday, September 21, 2016
FDA inaugurates app competition to fight against opioid overdoses
The Food and Drug Administration OR FDA inaugurates app competition to establish a low-cost, crowd-sourced, scalable mobile phone app to assist connect opioid users who are facing an overdose with nearby carriers of the prescription drug naloxone, a proposed medication that reverse the impacts of opioid overdose.
“With an instant increment in the number of opioid overdose deaths in the United States, there is a vital requirement to harness the power of latest technologies to rapidly and efficaciously link people experiencing an overdose—or a bystander like a friend or family member—with someone who carries and can administer the life-saving medication,” stated FDA Commissioner Robert Califf, MD. That’s why FDA inaugurates app competition to fight against opioid overdoses.
The Naloxone App Competition, which is launch to the public, will be conducted by the FDA, National Institute on Drug Abuse, and Substance Abuse and Mental Health Services Administration. Judges from the FDA, NIDA and SAMHSA will determine submissions and will grant $40,000 to the entrant with the greatest evaluated score.
“Through this competition, we’re tapping public health-focused innovators to assist to bring technological resolutions to a real-world issue that is charging the U.S. thousands of lives each year,” further state Califf.
In accordance to the FDA, many of these deaths could have been ignored if individuals experiencing an overdose had instantly got naloxone to prevent or reverse the impacts of an opioid overdose. The issue, the regulatory agency asserts, is that persons carrying naloxone might not be present when an overdose appears. Although, after FDA inaugurates app competition, officials say an app could help increase the likelihood that opioid consumers, their instant personal networks and 1st responders are capable to recognize and react to an overdose by administering naloxone.
“Mobile phone applications have been established to educate laypersons on how to identify an overdose and administer naloxone, and to link bystanders with people in requirement of other medical facilities, like CPR. To date, although, no application is present to connect carriers of naloxone with nearby opioid overdose victims,” stated Peter Lurie, MD, the FDA’s associate commissioner for public health strategy and analysis.
Those who need to enter the app competition have until the day of October 7 to register. Registrants will have approach to background resources, involving data on the opioid epidemic, the paased formulations of naloxone, the public health suggestions for the safe and suitable use of naloxone, as well as FDA instructions on mobile medical applications.
Additionally, the FDA will host an onsite code-a-thon October 19 and 20 at its proposed campus and virtually for registered entrants to establish their concepts and previous prototypes. The organization claimed that entire code will be made open-source and publicly approachable.
Participants will be needed to submit a video of a functional prototype along with a brief summary of their concept for the establishment and utilization of the app by the day of November 7.
Monday, May 30, 2016
FDA Passes Daclizumab (Zinbryta ) for Multiple Sclerosis
The US Food and Drug Administration (FDA) passed the daclizumab (Zinbryta, Biogen Idec) today for treatment of sufferers with relapsing forms of multiple sclerosis (MS), in accordance to an FDA news release.
The agency cautions, although, that the drug should be used only in sufferers who have failed to respond to one or two prior therapies, as the new agent has serious safety risks, including potentially severe liver damage and immune conditions.
The drug is offererd by self-administered subcutaneous injection once a month.
"Zinbryta provides an additional choice to patients who may require a new option for treatment," said William Dunn, MD, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, in the release.
The agency cautions, although, that the drug should be used only in sufferers who have failed to respond to one or two prior therapies, as the new agent has serious safety risks, including potentially severe liver damage and immune conditions.
The drug is offererd by self-administered subcutaneous injection once a month.
"Zinbryta provides an additional choice to patients who may require a new option for treatment," said William Dunn, MD, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, in the release.
Thursday, May 19, 2016
FDA proposes instructions on utilizing EHR data in clinical trials
New draft instructions from the Food and Drug Administration (FDA)) cover deciding whether and how to utilize EHRs as an information source in the clinical trials.
While the new instruction offers general guidance on EHR abilities, the new draft doesn’t involve provisions under which the FDA would assess agreement of records systems.
The agency’s draft covers utilizing EHRs that interoperate with electronic networks supporting trials, and explains ensuring the quality and integrity of information accumulated and used. FDA will agree to the comment on draft recommendations for sixty days before establishing final guidance.
The FDA’s lead in this place is significant because facilitating the correlation between EHRs and clinical trials would offer important benefits in speeding and cutting the prices of clinical trials, as well as streamlining the procedure of finding sufferers for research.
FDA initially released the separate guidance on electronic source information in clinical investigations, which appreciated that data can come from several sources and be entered into the trial sponsor’s Case Report Form (CRF), which is a paper or electronic questionnaire. This could involve information from EHRs—this latest proposed instruction concentrates on such data.
The agency doesn’t intend to actively assess agreement of EHRs used in trials with its rules. “Although, FDA’s acceptance of data from clinical investigations for decision-making purposes relies on FDA’s capability to verify the quality and integrity of data during FDA on-site inspections and audits,” in accordance to the guidance. Consequently, the agency is clarifying few hopes when EHRs are utilized as a source of data.
For example, FDA points out that interoperability of EHRs and a trial sponsor’s electronic data capture system (EDC) can simplify information collection by getting correct source data when a patient gets care. Such interoperability also can decrease the transcription errors and ease interpretation of data.
“FDA motivates the sponsors and clinical investigators to work with the entities that control the EHRs, like healthcare agencies, to use EHRs and EDC systems that are interoperable,” the draft guidance claims.
Another best practice for utilizing the EHR data in clinical trials is making sure the data is attributable, legible, contemporaneous, original and accurate. Further, FDA suggests utilization of ONC-certified EHRs and other health IT due to clear differences in interoperability and keeping data confidential.
Non-certified EHRs may be utilized, but should be assessed to determine if adequate controls are in place to make certain the data confidentiality, integrity and reliability. The assessment should involve limited access to electronic networks; identification of authors of records; audit trails to track changes to information; and availability and retention of records required for FDA inspection.
Moreover, trial sponsors should outline data flow between the EHR and the electronic data capture system, in accordance to FDA.
Other highlights of the instructions involve:
While the new instruction offers general guidance on EHR abilities, the new draft doesn’t involve provisions under which the FDA would assess agreement of records systems.
The agency’s draft covers utilizing EHRs that interoperate with electronic networks supporting trials, and explains ensuring the quality and integrity of information accumulated and used. FDA will agree to the comment on draft recommendations for sixty days before establishing final guidance.
The FDA’s lead in this place is significant because facilitating the correlation between EHRs and clinical trials would offer important benefits in speeding and cutting the prices of clinical trials, as well as streamlining the procedure of finding sufferers for research.
FDA initially released the separate guidance on electronic source information in clinical investigations, which appreciated that data can come from several sources and be entered into the trial sponsor’s Case Report Form (CRF), which is a paper or electronic questionnaire. This could involve information from EHRs—this latest proposed instruction concentrates on such data.
The agency doesn’t intend to actively assess agreement of EHRs used in trials with its rules. “Although, FDA’s acceptance of data from clinical investigations for decision-making purposes relies on FDA’s capability to verify the quality and integrity of data during FDA on-site inspections and audits,” in accordance to the guidance. Consequently, the agency is clarifying few hopes when EHRs are utilized as a source of data.
For example, FDA points out that interoperability of EHRs and a trial sponsor’s electronic data capture system (EDC) can simplify information collection by getting correct source data when a patient gets care. Such interoperability also can decrease the transcription errors and ease interpretation of data.
“FDA motivates the sponsors and clinical investigators to work with the entities that control the EHRs, like healthcare agencies, to use EHRs and EDC systems that are interoperable,” the draft guidance claims.
Another best practice for utilizing the EHR data in clinical trials is making sure the data is attributable, legible, contemporaneous, original and accurate. Further, FDA suggests utilization of ONC-certified EHRs and other health IT due to clear differences in interoperability and keeping data confidential.
Non-certified EHRs may be utilized, but should be assessed to determine if adequate controls are in place to make certain the data confidentiality, integrity and reliability. The assessment should involve limited access to electronic networks; identification of authors of records; audit trails to track changes to information; and availability and retention of records required for FDA inspection.
Moreover, trial sponsors should outline data flow between the EHR and the electronic data capture system, in accordance to FDA.
Other highlights of the instructions involve:
- When healthcare experts not part of the investigation modify or accurate EHR data that will be utilized in a trial, ensure modifications don’t obscure previous entries.
- Audit trail documentation of HER information should be retained at least as long as the time period needed for the subject’s electronic records, and should be present for FDA to review and copy.
- Informed consent must involve the extent to which subject confidentiality will be maintained and recognize entire entities who might have access to the subject information.
- Sponsors should consider safeguards to secure information from subjects who participate, decide to discontinue involvement or are discontinued from involvement by the clinical investigator.
Monday, March 28, 2016
Three Ways to Be More Innovative With Healthcare Advertising
Let the future of medicine inspire you. My new go-to is bioelectronics, tiny disease-modifying tools that work sort of like a Nest temperature system. The field joins wireless miniaturization, material science, computer electronics, data science, neuroscience and electronic engineering to tap into a body's electrical impulses and teach the body to heal itself.
This is great news for the 117 million Americans who have a chronic sickness. It is about ten years away from reality, which is not that long in pharma years. But the promise of being capable to do some tasty, transformative creative has me learning all I can right now.
Construct and sell a social strategy. It is not as crazy hard as it sounds. And clients really, really need it. They know the value of being part of the conversation. Regrettably, conversations are where it all falls apart. Fair balance is so intrusive. And side effect chatter can trigger a complete course of events that nobody needs to deal with. But these are not walls. They are hurdles. We can assist our clients clear them.
There are plenty of good instances of pharma-sponsored Twitter feeds, Facebook pages, YouTube channels and Pinterest pages to pull from. Start there. Know where the FDA stands. Know your client's social media policy. Have a policy for how to handle and facilitate engagements in a way that drives both compliance and traffic. Do all of that and you will get something back: an opportunity to create a beautiful, fluid, dynamic conversation piece that really connects with patients.
Create a digital solution the world will not need to live without. Medical apps were downloaded 160 million times previous year. Good? Not really. Med tech experts interpret this information as major room for improvement in how we design digital experiences for sufferers and caregivers. There is a call to give better simplification through customization and integration. Sufferers don't need all the data at once. They want the right information one click away when they require it.
Tuesday, February 23, 2016
FDA reform, privacy law standards required in next healthcare overhaul, group claims
The Healthcare Leadership Council has recognized 6 healthcare reforms that should be executed by the White House, Congress and the healthcare industry to reform healthcare; it was declared previous week at a Capitol Hill briefing and in a report highlighting the changes.
For starters, nationwide health data interoperability in the private sector should be gained by December 31, 2018, the group stated.
The group also aimed the Food and Drug Administration, claiming reforms that focus on decreasing administrative burdens placed on the organization should be enacted so the FDA can better bring innovative treatments and technology to sufferers
Tuesday, June 21, 2011
FDA Plans to Extend Its Global Regulatory Reach
June 20, 2011 — The US Food and Drug Administration (FDA) plans to take a more global approach to ensure the safety and quality of regulated drugs and medical devices, the agency's commissioner announced during a media briefing today.
One prong of the new 4-pronged approach will involve partnering with counterparts worldwide and creating global coalitions of regulators intent on ensuring and improving global product safety and quality, said FDA Commissioner Margaret Hamburg, MD.
"This is a long-term strategy," Dr. Hamburg said. "It cannot be accomplished immediately and will probably take many years to implement, depending upon resources."
One part of the new approach will mean regulators no longer regard borders the same way. "The border can no longer be the nation's primary line of defense against unsafe imported products," she said. "Instead, the border must serve as a final checkpoint on preventive controls throughout the supply chain."
An FDA report, Pathway to Global Product Safety and Quality, describes the new strategy. Most notably, it calls for the agency to change how it conducts business and to take a more global approach to promote and protect the health of US consumers. Highlights of the report include 3 other prongs of the 4-pronged approach:
- The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets.
- The FDA will build in more information gathering and analysis, with an increased focus on risk analytics and information technology.
- The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk.
Such coalition-type models do not exist in the world of FDA-regulated products, said John Taylor, JD, acting principal deputy commissioner of the FDA, and the FDA does not already have a coalition in place. However, many peer regulators have expressed interest in working more closely together to ensure the safety and integrity of products moving through the global supply chain.
Current Regulatory Authority Outdated
When asked whether the FDA would need new authority from Congress to proceed with the project, Taylor said the agency would move ahead with the strategy regardless of whether it needs new authority to do so. He also noted that the agency's authority relating to medical products is outdated. In 1938, the authority given to the FDA largely grew out of a world where manufacturers of regulated products were based in the United States.
"We've been a domestic agency that works in an international world," he said. "What we need to do is transform ourselves into a global agency that is able to work all around the world and address product issues that arise all over the world."
Taking a more global approach will enable the FDA to better monitor companies in far-flung areas that might otherwise escape regulatory scrutiny as more FDA-regulated products are produced overseas.
Global production of FDA-regulated goods has exploded over the past 10 years, according to Dr. Hamburg. Manufacturers increasingly use imported materials and ingredients in their US production facilities, "making the distinction between domestic and imported products outdated, to say the least," she said.
Products regulated by FDA, Dr. Hamburg said, reflect the globalization of today's economy:
- 10% of all imports into the United States consist of products FDA regulates,
- 80% of active pharmaceutical ingredients in the drugs Americans use come from overseas,
- 40% of drugs themselves are imports, and
- about half of all medical devices used in this country are imported.
Yet the FDA does not have the resources to keep pace with demands created by globalization, according to the report issued today that describes the FDA's new plan. In 2008, the Government Accountability Office recommended that the FDA increase inspections of foreign drug companies, but at current rates, it would take 9 years for the agency to inspect every high-priority pharmaceutical facility just once.
The new strategy would build on changes already made by the FDA. Between 2007 and 2009, the FDA increased the number of foreign drug manufacturing inspections by 27% and opened international offices in several key locations around the world.
The FDA has also collaborated with counterparts in the European Union and Australia on drug inspections, and it has joined an organization of drug manufacturing inspectorates from 39 countries. The FDA and other global leaders are also creating an expanded global regulators forum for medical devices.
More information on the new strategy is available on the FDA Web site.
Friday, February 11, 2011
Tort Reform Needs To Be Done At Federal Level
There are many aspects of healthcare as it relates to physicians that are federally regulated. This started with the Flexner Report in 1910. Look at the FDA and the license for physicians to prescribe controlled substances.
Wednesday, March 17, 2010
Recall -- Firm Press Release
Barcel Announces Voluntary Recall
For More Information:
David Margulies
Elizabeth Watters
214-368-0909
FOR IMMEDIATE RELEASE - March 16, 2010 - Irving, Texas - Barcel was notified by one of its suppliers that a seasoning used in Barcel Tostachos contains hydrolyzed vegetable protein (HVP) manufactured by Basic Food Flavors, Inc., which has voluntarily recalled several lots of this ingredient because of potential Salmonella exposure.
In response, Barcel announced today that it is voluntarily recalling:
| Authorized Item for Recall | Unit UPC Code | Lot # |
|---|---|---|
| Tostachos 3.17 oz | 074323 04358 7 | AUG1110, AUG1810, AUG2510, SEP0110 |
Lot numbers are located on the front of the product packaging in the upper right corner.
No other Barcel products are involved in this recall.
At this time, no illnesses associated with this contamination have been reported to the FDA.
Consumers who have purchased this product can contact Barcel at (800) 354 3372 from Monday to Friday, 9:00 a.m. – 5:00 p.m.
Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
###
Monday, March 15, 2010
FDA Announces New Boxed Warning on Plavix
Alerts patients, health care professionals to potential for reduced effectiveness
The U.S. Food and Drug Administration today added a boxed warning to the anti-blood clotting drug Plavix (clopidogrel), alerting patients and health care professionals that the drug can be less effective in people who cannot metabolize the drug to convert it to its active form.
Plavix reduces the risk of heart attack, unstable angina, stroke, and cardiovascular death in patients with cardiovascular disease by making platelets less likely to form blood clots. Plavix does not have its anti-platelet effects until it is metabolized into its active form by the liver enzyme, CYP2C19.
People who have reduced functioning of their CYP2C19 liver enzyme cannot effectively convert Plavix to its active form. As a result, Plavix may be less effective in altering platelet activity in those people. These "poor metabolizers" may not receive the full benefit of Plavix treatment and may remain at risk for heart attack, stroke, and cardiovascular death.
"We want to highlight this warning to make sure health care professionals use the best information possible to treat their patients," said Mary Ross Southworth, Pharm.D., a clinical analyst in the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research.
In May 2009, the FDA added this warning to the drug's label. After reviewing more data, the agency felt it was important to highlight this risk in a boxed warning.
It is estimated that 2 percent to 14 percent of the U.S. population are poor metabolizers. The FDA recommends that health care professionalsconsider alternative dosing of Plavix for these patients, or consider using other anti-platelet medications. Tests are available to assess CYP2C19 genotype to determine if a patient is a poor metabolizer.
Patients should not stop taking Plavix unless told to do so by their health care professional. They should talk with their health care professional if they have any concerns about Plavix.
Plavix is made under a Bristol-Myers Squibb - Sanofi Pharmaceuticals partnership.
For information:
FDA Drug Safety Communication: Reduced effectiveness of Plavix (clopidogrel) in patients who are poor metabloizers of the drug
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203888.htm
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