Pharmaceutical

FDA finds no increased risk of death, cancer with Plavix

Plavix FDA finds no increased risk of death, cancer with PlavixLong-term use of the blood thinner Plavix (clopidogrel) does not increase the overall risk of death in patients who have or are at risk for heart disease, nor are they at increased risk of cancer or death from cancer, according to a Food and Drug Administration (FDA) Safety Advisory. The announcement comes after an agency review of several long-term clinical trials evaluating rates of death, death from cancer, or cancer reported as adverse events.

The FDA performed the meta-analyses of long-term clinical trials to assess the effects of Plavix on death rates from all causes. The results showed that long-term, defined as 12 months or longer, dual antiplatelet therapy with Plavix and aspirin do not appear to change the overall risk of death when compared to short-term, defined as six months or less) treatment with Plavix and aspirin, or aspirin alone. There was also no apparent increase in the risks of cancer-related deaths or cancer-related adverse events with long-term treatment.

The makers of Plavix and its generics are working with the FDA to update the safety labels of the drugs. Patients are advised not to stop taking Plavix or other antiplatelet medications because doing so may increase the risk of heart attacks and blood clots. Patients should contact their doctors with questions.

Plavix is an antiplatelet medication used to prevent blood clots in patients who have had a heart attack, stroke or problems with the circulation in the arms and legs. It works by helping to keep the platelets in the blood from sticking together and forming clots that can occur with certain medical conditions.

The safety announcement comes one year after the FDA notified doctors and patients that a study showed that 30-month treatment with Plavix and the platelet inhibitor Effient (prasugrel) had been linked to a decreased risk of heart attacks and clot formation in stents, but there was an increased overall risk of death compared to 12 months of treatment.

Any adverse effects with Plavix should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Sources:
FDA – Plavix (clopidogrel): Drug Safety Communication – Long-term Treatment Does Not Change Risk of Death
FDA – Long-term Antiplatelet Therapy: Safety Announcement – Preliminary Trial Data Shows Benefits But a Higher Risk of Non-Cardiovascular Death