Public Citizen Requests that the FDA Require a Black Box Warning for Plavix®
According to the Associated Press, the advocacy group Public Citizen filed a petition with the United States Food and Drug Administration (FDA) last week requesting that a Black Box Warning be added to the Plavix® product label to alert people to the risks of major bleeding when the drug is used by patients who have received artery-opening stents. In particular, Public Citizen requests that the FDA should warn doctors and patients that taking Plavix® for more than one year after receiving a drug-coated stent can lead to fatal bleeding.
Plavix® is often prescribed to reduce the risk of heart attack in patients who have received a stent to prop open their arteries; however, Dr. Sidney Wolfe, of Public Citizen’s Health Research Group, stated, “The research shows that using this drug for more than 12 months puts people at risk of potentially life-threatening bleeding, without any evidence that it’s doing any good at that point.” The Black Box Warning proposed by Public Citizen would appear at the top of the Plavix® label and highlight the increased risk of bleeding associated with Plavix® for prescribing doctors and patients.
Plaintiffs throughout the country have filed lawsuits against drug makers Bristol-Myers Squibb and Sanofi-Aventis claiming they have suffered serious injuries and bleeding episodes from the use of Plavix®. Plavix® was approved in 1997 and is commonly prescribed to patients at risk for heart attack, stroke, or blood clotting. It is often prescribed along with a low-dose aspirin regimen for patients at high risk for heart attack. It is alleged that the manufacturers promoted Plavix® as being more effective than aspirin, albeit the lower risk of complications associated with aspirin, in preventing blood platelets from sticking together and forming clots.
In February, the United States Judicial Panel on Multidistrict Litigation (JPML) decided to consolidate all Plavix® lawsuits filed in the federal court system before the Honorable Judge Freda L. Wolfson in the United States District Court of New Jersey for coordinated pretrial purposes. Currently, there are 52 Plavix® lawsuits pending in this Multidistrict Litigation (In re: Plavix® Products Liability, MDL 2418).
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