April 27, 2000 - Merck's Vioxx Seen Facing FDA Scrutiny On Heart Attacks
In the recent months and after several medicines linked to deaths and other serious side effects were recalled, the FDA has shown more concern over the safety of prescription drugs that are already on the market than those still waiting for approval.
Arthritis drug Vioxx, taken by more than six million Americans since its 1999 release by Merck & Co.'s, is likely to face higher scrutiny from U.S. regulators because a number of patients who took Vioxx in clinical trials suffered strokes and heart attacks.
According to David Saks, a manager of Gruntal & Co's Medical Sciences Fund, "The heart attacks and strokes could be a serious concern for the Food and Drug Administration, and could delay or derail Merck's plans to market Vioxx for rheumatoid arthritis.''
Vioxx is one of the fastest-selling new drugs in the world. It was approved by the FDA last May for treatment of acute pain and osteoarthritis, the most common form of arthritis caused by normal wear and tear of joints, and afflicting 21 million Americans. Some analysts expect sales of Vioxx, which were worth $472 million last year, to rise to $2 billion or more by 2002.
FDA spokesperson Susan Cruzan told Reuters she could not comment on how closely her agency might scrutinize Merck's rheumatoid arthritis marketing application and the related heart attack and stroke data and that "It's too early to comment about that. We will review the study and the results for both drugs,'' she said, referring to comparisons between Vioxx and Naproxen.
The FDA continues to believe that Vioxx is "effective and adequately safe'' for its labeled uses, added Cruzan. On Wednesday, Merck spokeswoman Jan Weiner, acknowledged that there was a clear trend of fewer heart attacks and strokes in the Naproxen study group, compared to Vioxx group. However, there was no evidence Vioxx had actually put patients at higher risk of heart-related adverse events.
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