Health Canada reviewing possible safety concerns with certain long-term antiplatelet (blood thinner) therapy; Benefits of treatment still outweigh potential risks

Issue

Health Canada is aware of and will be reviewing new evidence on the safety of long-term use of the prescription blood-thinners clopidogrel (Plavix) and prasugrel (Effient).

Clopidogrel and prasugrel reduce the risk of blood clots in patients who have had a heart attack, stroke or related blood clotting diseases. Dual antiplatelet therapy is the use of a blood thinner in combination with ASA (acetylsalicylic acid or Aspirin). It is commonly used following coronary stent implantation to reduce the risk of blood clots. Coronary stents are tiny tubes that are implanted in narrow or weak heart arteries to maintain blood flow to the heart.

It is important to note that Health Canada has not reached new conclusions or made recommendations regarding clopidogrel or prasugrel safety at this time. The benefits of clopidogrel and prasugrel in protecting against blood clots continue to outweigh their risks when used as directed.

The new evidence is from the Dual Antiplatelet Therapy (DAPT) Study, a large-scale, multi-national clinical trial that evaluated 12 versus 30 months of clopidogrel or prasugrel use with ASA, known as dual antiplatelet therapy. The study looked at how these drugs can prevent blood clots in patients with coronary stents. Its findings were recently published in the New England Journal of Medicine.

Health Canada is evaluating preliminary information from the study, which found that 30 months of dual antiplatelet therapy was beneficial in reducing blood clots and heart attacks relative to 12 months, but saw an increase in deaths due to non-cardiovascular causes in the 30-month group versus the 12-month group.

Health Canada will continue to evaluate the available information from this trial along with other information, and is aware of the recent communication issued by the U.S. Food and Drug Administration. Health Canada will take appropriate action based on the results of the review once it is complete, including communicating new safety information to health professionals and Canadians as necessary.

Patients with questions or concerns about their dual antiplatelet therapy should talk to their doctor.  Patients should not stop using clopidogrel and prasugrel unless on the advice of their healthcare professional. Stopping treatment may increase the risk of blood clots, which can be fatal.

USFDA Drug Safety : FDA reviews long-term antiplatelet therapy as preliminary trial data shows benefits but a higher risk of non-cardiovascular death

FDA is evaluating preliminary data from a clinical trial showing that treatment for 30 months with dual antiplatelet blood-thinning therapy decreased the risk of heart attacks and clot formation in stents, but there was an increased overall risk of death compared to 12 months of treatment. The clinical trial compared 30 months versus 12 months of treatment with dual antiplatelet therapy consisting of aspirin plus either clopidogrel (Plavix) or prasugrel (Effient), following implantation of drug-eluting coronary stents. These stents are small, medicine-coated tubes inserted into narrowed arteries in the heart to keep them open and maintain blood flow to the heart. Clopidogrel and prasugrel are important medicines used to prevent heart attacks, strokes, and other clot-related diseases.

FDA believes the benefits of clopidogrel (Plavix) and prasugrel (Effient) therapy continue to outweigh their potential risks when used for approved uses. Patients should not stop taking these drugs because doing so may result in an increased risk of heart attacks, blood clots, strokes, and other major cardiovascular problems. Health care professionals should not change the way they prescribe these drugs at this time.

The Dual Antiplatelet Therapy (DAPT) trial was published in the New England Journal of Medicine on November 16, 2014. FDA has not reviewed the trial results or reached any conclusions based on the findings from this clinical trial. We are communicating this safety information while we continue to evaluate the results from this trial and other available data. We will communicate our final conclusions and recommendations when our evaluation is complete.

For more information, please visit: Antiplatelet

USFDA CDRH Medical Device Safety and Recalls: Covidien, Medi-Trace Cadence and Kendall Defibrillation Electrodes...

A recall has been issued for the Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes because the electrodes will not work with Philips FR3 and FRx Automated External Defibrillators.  

Philips made changes to the design of their connectors for the FR3 and FRx AEDs, and because of these changes, the Covidien defibrillation electrodes will not work with these AEDs.  Use of these electrodes could cause a delay in delivering electrical therapy that is needed to revive patients. Additionally, their use could lead to severe health problems such as stroke, organ failure, or death if alternative defibrillator electrodes are not readily available. Covidien received two reports of injuries. There was a delay in resuscitating one patient which may have contributed to the subsequent death of the patient.  

For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm419565.htm

Health Canada : Government advances measures to make cosmetic contact lenses safer...

Today, in a move widely supported by optometrists, ophthalmologists and opticians, the Honourable Rona Ambrose, Minister of Health, announced that Health Canada will be consulting on new guidance for industry that will lead to non-corrective or ‘cosmetic’ contact lenses being regulated as medical devices.

‘Cosmetic’ contact lenses (also called decorative lenses) are used to change the colour or appearance of the eyes and are typically sold by costume and cosmetic retailers. Until now, these types of lenses have been regulated as consumer products. However the risks of decorative lenses are identical to the risks of corrective lenses and adverse events causing harm and even permanent damage to the eyes are not uncommon.

As medical devices, cosmetic contact lenses would be subject to specific requirements for licensing, manufacturing, labeling, and instructions to improve their safety before they go on the market. The proposed changes to the Medical Device Regulations are being published in Canada Gazette I on October 18 to begin consultations. In addition, new guidance documents and new application forms will be posted on the Health Canada website for a 75-day comment period.

Quick Facts

• Contact lenses are not suitable for everyone. Some people are more at risk of adverse reactions.
• Smokers who use contact lenses are eight times more likely to develop corneal ulcers than non-smokers, no matter which type of contact lenses they wear.
• According to a recent French study, the risk of severe corneal infection related to contact lens wear for cosmetic purposes is 12.5 times higher than with corrective contact lenses.

Quotes

“Improving patient safety is a priority for our Government. These new measures will help to make cosmetic contact lenses safer for Canadians, protecting our eyes and vision from needless harm.” Rona Ambrose Minister of Health

“I’m very pleased by the actions taken by the Government, in accordance with Private Members Bill C-313, to ensure that moving forward Cosmetic contact lenses are made subject to the same licensing, manufacturing and labeling as has long been required for regular, prescription contact lenses. I believe these consumer protection measures announced today by the Government of Canada go a long way towards addressing the concerns expressed by Canadian eye care professionals from coast to coast to coast. “ Pat Davidson Member of Parliament: Sarnia-Lambton

“The Canadian Association of Optometrists and other vision health professionals are concerned about the great risk of harm to the eye and vision caused by the use of non-corrective contact lenses – primarily due to improper use and supervision. We are very happy to see these proposed new regulations moving forward.” Dr. Paul Geneau, President Canadian Association of Optometrists