Plavix Warnings

The manufacturers of Plavix have received several FDA warning letters regarding false and misleading statements made in promotional materials for the blood thinner. These FDA letters suggest that the manufacturers may have been more concerned with increasing sales, even at the expense of providing fair and accurrate information to consumers and physicians.

INFORMATION: Plavix Warnings and Side Effects

At the time Plavix was developed, the makers own studies demonstrated that the drug was not any better than Aspirin at preventing heart attacks and strokes. Through proper evaluation of clinical trials, the limited benefits and increased risk of heart attacks, strokes, internal bleeding and death should have been apparent, according to lawsuits pursued by former users of the medication.

The lawyers at Saiontz & Kirk, P.A. are no longer pursuing new Plavix cases. Content of this website is provided for informational purposes, outlining allegations and claims raised by former users of Plavix.

INFORMATION: Plavix Problems Confirmed in Studies

Below are some of the Plavix warnings issued by the FDA to Sanofi-Aventis and Bristol-Myer Squibb insisting that they change their misleading statements and stop promoting unproven uses of the medication.

▸ PLAVIX WARNING: Promoting unapproved usage and unsafe dosage

In 1998 the Food and Drug Administration reprimanded the manufacturers for promoting Plavix for use in patients receiving stents when that was not an approved use. The manufacturers also improperly recommended a dose which was nearly four times higher than what had been approved as safe in initial clinical trials. The Plavix warning letter also criticised the failure to disclose any of the risks associated with Plavix.

▸ PLAVIX WARNING: False and misleading statements lacking fair balance

Another Plavix warning letter in 1998 identified violations in product brochures, medical journal advertisements and promotional videos. The claims that Plavix was superior to Aspirin were called false and misleading by the FDA. Federal regulators also pointed out that the materials lacked fair balance since they failed to present information about Plavix side effects, warnings and precautions. The FDA demanded that the use of these promotional materials stop immediately.

▸ PLAVIX WARNING: Drawing unproven conclusions and ignoring unfavorable data

In May 2001, a Plavix warning letter directed the manufacturers again to stop making unsubstantiated claims about Plavix. Advertisements selectively presented the most favorable information while ignoring unfavorable data. Claims that Plavix was better than Aspirin were presented without contextual information necessary for physicians to interpret the data they presented. In addition, they found the risk information was minimized, which failed to provide a fair balance.

▸ PLAVIX WARNING: Failure to report serious and unlabeled side effects

In September 2001, the manufacturers were notified that they violated Federal regulations by failing to properly report the number or serious and adverse drug reactions in a timely manner. The FDA expects drug manufacturers to promptly report information regarding serious or unlabeled side effects to protect consumers.