Plavix safety risks ignored in makers’ push for profits
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Plavix was approved in April 1997 after a rare priority regulatory review by the FDA. The expedited review was requested so that the medication could be brought to the market very quickly. When FDA advisory panel recommended that the agency approve the drug, reservations were expressed by some panel members about the benefits of Plavix. Some researchers indicated that although Plavix would be approved, they were not convinced that it was any safer or more effective than Aspirin at preventing heart attacks and strokes. It appears that those concerns were well founded since recent studies have demonstrated that Plavix has no benefit over Aspirin and may actually increase the risk of heart attacks, strokes, abnormal bleeding and ulcers for some users.
>>MORE INFORMATION: Plavix side effects
After the FDA approved Plavix, the manufacturers aggressively marketed the medication, and it was pushed by drug representatives for uses that were beyond what had been found safe. An article published in the New York Times on October 25, 1997 estimated that the new medication may generate between $300 million and $1 billion in annual sales over the coming years. However, as a result of over-promotion and exaggerated statements about the benefits of Plavix, sales currently exceed $6.3 billion a year.
The manufacturers have received several FDA Plavix warning letters as a result of what they considered false, misleading and unsubstantiated promotional statements. They were more concerned with generating increased sales, even if it increased the risk of injury for users.
The fact that the manufacturers rushed the FDA approval process is further indication of the priority they placed on their ability to bring the product to market and profit from the medication, even at the expense of patient safety.
Recently criminal investigations have surrounded Bristol-Myers Squibb for their fraudulent actions in trying to keep generic Plavix from reaching the market and impacting their exclusive market on the blood thinner. This is further evidence that this corporation is willing to bend the rules to generate a profit.
Our lawyers are investigating Plavix lawsuits for users of the blood thinner who have suffered a heart attack, stroke, internal bleeding, ulcers or death. To find out if you or a family member has a claim, request a free case evaluation.