Merck Voluntarily Recalls Vioxx Globally
AI-generated context summary requested by a Free News Reader user. Sourced via Gemini from publicly available information — no paywalled content was accessed.
You hit a paywall. Here’s the context on this topic based on publicly available information. We did not access any paywalled content. View original article.
Merck Voluntarily Recalls Vioxx Globally
- Merck voluntarily withdrew its arthritis and pain medication Vioxx from the global market on September 30, 2004, after a clinical trial showed an increased risk of heart attack and stroke.
- Raymond V. Gilmartin, then Merck's chairman, president, and CEO, stated the withdrawal was in the best interest of patients, despite the company's belief it could have continued marketing the drug with updated labeling.
Full Summary — powered by AI
On September 30, 2004, pharmaceutical company Merck & Co. announced the voluntary worldwide withdrawal of its drug Vioxx (rofecoxib), used to treat arthritis and acute pain. This decision stemmed from new data from the APPROVe (Adenomatous Polyp Prevention on VIOXX) clinical trial, which indicated an increased risk of confirmed cardiovascular events, such as heart attack and stroke, in patients taking the medication for longer than 18 months.
Vioxx was initially launched in the United States in 1999 and marketed in over 80 countries, with global sales reaching $2.55 billion in 2003. By the time of its withdrawal, approximately 2 million people worldwide were taking the drug. This was not the first time cardiovascular concerns had been raised; results from the VIGOR (Vioxx Gastrointestinal Outcomes Research) study in March 2000 also suggested an increased risk of cardiovascular events compared to another painkiller. In response, the FDA requested labeling changes in April 2002 to reflect these findings.
Merck’s chairman, president, and CEO, Raymond V. Gilmartin, stated that while the company believed it could have continued to market Vioxx with updated labeling, a voluntary withdrawal was the “responsible course to take” given the availability of alternative therapies and the questions raised by the data. The FDA acknowledged Merck’s voluntary withdrawal on September 30, 2004, and issued a Public Health Advisory advising patients to consult their physicians about alternative treatments. The withdrawal led to a significant drop in Merck’s stock value, reducing it by $25 billion.