Merck, already facing more than 3,800 lawsuits filed for patients allegedly killed or injured by its Vioxx painkiller, was hit with a new legal attack recently as the state of Texas accused the firm of covering up the drug's health risks.
The FDA announcement is not surprising. 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 that results in strokes and leg clots.
The drug 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.
