Consumers Urge FDA to Include Black Box Warning on Plavix

Plavix lawyers at Pintas & Mullins Law Firm report that the consumer group Public Citizen is increasing its urges to the FDA to place a Black Box Warning, the agency’s most severe caution, on the blood-thinner Plavix. The drug has been known to cause fatal bleeding in stent implant recipients if taken for longer than one year.

Several studies have noted that patients taking Plavix (clopidogrel) for long periods of time fail to demonstrate any health benefits, and actually have an increased risk of internal bleeding. The drug is prescribed to patients after being implanted with a coronary artery stent to keep arteries open following heart surgery. The stent is designed to reduce the risk of heart attack and stroke by promoting normal blood flow.

Although stents are generally considered safe, blood-thinning drugs need to be taken to reduce the development of clots in and around the implant. Patients are typically prescribed Plavix or other blood thinners for a year or more, and then take aspirin for the proceeding years. It is becoming increasingly clear, however, that those taking Plavix for longer than a year may have a severely increased risk of a major bleeding episode.

The study cited by Public Citizen was recently presented at the American College of Cardiology’s Annual Scientific Session. The advocacy group is requesting a Black Box warning for Plavix as well as medication guides for Plavix patients with information about the risks, which they would receive every time they fill their prescription. It also wants manufacturers to send letters to physicians warning them of the long-term risks in stent recipients.

Plavix is manufactured by Bristol Myers-Squibb and Sanofi, which are currently facing numerous Plavix-related lawsuits in a multi-district litigation (MDL) filed by patients injured by the drug. Plaintiffs allege that the manufacturers failed to warn them about the drug’s risks and claim they violated the False Claims Act in marketing Plavix for uses not included on its labels. The U.S. Department of Justice is currently investigating Sanfoi over its reports to the FDA concerning patient responses to Plavix.

More than 25 million prescriptions for Plavix were written in the past year alone, despite the 2010 Black Box Warning stating that Plavix does not properly metabolize in about 2 to 14% of the population. Plaintiffs in the MDL allege Plavix manufacturers overstated the efficacy of Plavix. More and more patients are filing claims as the year progresses, with dozens of constituents in several different districts.

The MDL includes a whistleblower lawsuit filed by the federal government and plaintiff Elisa Dickson, who alleges that Bristol-Myers and Sanofi engaged in a scene to fraudulently market Plavix to physicians as superior to other blood-thinning drugs. This false marketing resulted in an innumerable amount of unnecessary prescriptions, putting patient safety at risk. The manufacturers are also accused of manipulating clinical data to support claims that Plavix was better than its rivals at preventing stroke, vascular death and heart attack, and downplaying conflicting studies.

Even further compounding the false claims, according to the whistleblower suit, the companies also told sales staff to target marketing of Plavix to doctors with high numbers of Medicaid and Medicare patients. The health risks Bristol-Myers and Sanofi willingly concealed from physicians and patients include the risk of internal bleeding, heart attack and stroke, fatal bleeding events, and blood disorders. Though it is now confirmed that prolonged use of Plavix causes these risks, it is still unknown exactly how long patients should continue taking the drug to minimize the risk of complication and maximize benefits.

Plavix attorneys at Pintas & Mullins Law Firm will continue to report on any updates concerning Plavix and the litigation against its manufacturers. If you or a loved one was prescribed to Plavix and suffered a major bleeding episode, you have important legal rights, and may be entitled to compensation for your medical bills or for your loved one’s wrongful death.