1. Withdrawn From the U.S. Market
Merck and Co., the manufacturer of Vioxx, pulled the drug from the market in 2004 after post-market studies indicated an increased risk of heart attack, stroke and other cardiovascular events associated with the drug. Vioxx lawsuits charged the company with failing to indicate the increased risk, wrongful death and injury. Without admitting fault, the company agreed to pay a $4.85 billion Vioxx settlement, not a class-action settlement, for cases opened before November 8, 2007.
2. A Popular NSAID
Doctors prescribed Vioxx, a nonsteroidal anti-inflammatory drug (NSAID), to treat symptoms associated with conditions like arthritis, migraines and menstrual cramps. Before FDA approval, the drug showed a positive ability to safely reduce pain, stiffness and inflammation. The manufacturer recommended that people who smoked, drank or had a medical history including liver, kidney or heart disease not take Vioxx due to an increased risk of developing serious side effects. Before its withdrawal, Merck sold the drug in over 80 countries.
3. A Killer Painkiller
The FDA approved Vioxx for use in 1999. As early as 2000, studies indicated an increased risk of cardiovascular trauma in people taking the drug. Despite these findings, the FDA did not require a label warning on the product until 2001. David Graham, an FDA researcher, linked Vioxx to 27,000 heart attacks and deaths caused by cardiac events during the years the drug was on the market. Factors like obesity and cardiovascular issues caused from smoking further increased the chance of life-threatening side effects.
4. A New Class of NSAIDs
The most common side effects of NSAIDs are gastrointestinal problems like abdominal pain or diarrhea, which prompted the creation of alternative NSAIDs. All first-generation, or classic, NSAIDs inhibit the COX-1 enzyme, which researchers believe increases the occurrence of gastrointestinal problems. The FDA approved Vioxx as one of the first COX-2 inhibitors, which block the COX-2 enzyme. This enzyme triggers inflammation in the body.
5. Replaced by Celebrex
Celebrex, the main competitor for Vioxx, remains on the market. With one 200 mg dose, Celebrex relieves pain, swelling and inflammation for 24 hours. The FDA now requires all NSAIDs to carry the same cardiovascular warning; however, Celebrex tests do not show the same level of risk associated with Vioxx. Along with the cardiovascular warning, the FDA also labels Celebrex as inducing gastrointestinal problems like ulcers. Celebrex remains under constant scrutiny because of its similarity to Vioxx.
