Vioxx Recall - Merck's Blockbuster Hit Pulled From The Market

September 30, 2004

Vioxx (rofecoxib) was launched in 1999 and has become a blockbuster hit for manufacturer Merck & Co. After recent safety concern s flattened its sales to a still highly profitable $2.55 billion in 2003 alone, Merck has announced it is issuing a voluntary withdrawal of Vioxx. Clinical trial data has shown Vioxx increased the risk of blood clots linked to strokes and heart attacks, and after a long-term Vioxx study by Merck's data safety monitoring board confirmed the increased risk of serious cardiovascular events, they recommended the study be halted and a recall be issued.

The Vioxx recall is considered a huge blow to Merck. Vioxx is one of Merck's most popular drugs and since its 1999 introduction, 91 million Vioxx prescriptions have been written in the U.S. alone. In April 2002, the FDA implemented Vioxx labeling changes after Merck submitted a safety study in June 2000 finding an increased risk of serious cardiovascular event s , including heart attacks and strokes, in patients taking Vioxx compared to those taking naproxen. A recent FDA study found patients taking Vioxx faced a 50 percent greater risk of heart attacks and sudden cardiac death compared to those taking Pfizer's arthritis treatment Celebrex . Other studies in patients taking Vioxx have also suggested the increased risk of cardiovascular events to be present.

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