Vioxx Recall Summary

Vioxx Lawsuit Information. Heart Attack And Stroke Side Effects Prompt Merck Recall: Vioxx Recall Summary

The following is a short summary of information concerning the Vioxx recall:

On September 30, 2004 Merck announced the removal of the popular anti-inflammatory drug Vioxx from the market. This Vioxx recall was due to a study they were conducting that shows patients taking the drug face twice the risk of heart attack compared to those in the test taking a placebo.

Vioxx is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms.

The Vioxx recall is the largest withdrawal of any drug. Vioxx has been on the market around the world since about 1999 and has been prescribed millions of times. In 2003 alone, the drug accounted for $2.5 billion in sales.

According the FDA, patients who are currently taking Vioxx should contact their physician for guidance regarding discontinuation and alternative therapies.

In Merck's Vioxx Gastrointestinal Outcomes Research report published in the New England Journal of Medicine (November 23, 2000), Merck compared the effectiveness of Vioxx (rofecoxib) to naproxen. The study shows a statistically significant increase in heart attacks in the rofecoxib group (0.5 percent) compared to the naproxen group (0.1 percent). There were 20 heart attacks suffered by 4,047 Vioxx patients and 4 heart attacks in 4,029 naproxen patients. While the absolute numbers are low, this is a five-fold increase that statistically is highly significant and merited further studies. In addition the study reported increased problems with blood clotting (which results in strokes and leg clots).

A study led by a Food and Drug Administration safety official projects that the widespread use of Vioxx may have led to more than 27,000 heart attacks and sudden cardiac deaths before the drug's abrupt recall.

A joint study by the Kaiser Permanente Medical Foundation and the FDA reported a tripling of heart attack risk among patients who took double the standard 25 mg. dose.