Vioxx – FDA Information
Vioxx recalled voluntarily by its manufacturers and FDA issues Public Health Advisory to the same.
On 30th September 2004, FDA acknowledged the withdrawal of Vioxx, manufactured by Merck and Company. It also issued the drug a public health advisory, spreading the awareness of the side effects of the drug and also suggesting the patients to consult a practitioner before taking the medicine.
Acting FDA commissioner of that time Dr. Lester M. Crawford commented that post the study, which suggested that Vioxx had an increased risk of serious cardiovascular events, including heart attacks and strokes, the manufacturer promptly took the corrective action by first reporting the side effects of the drug to FDA and then recalling it worldwide. Dr. Lester M. Crawford maintained that most of the nonsteroidal anti inflammatory drugs come with a risk of gastrointestinal, liver or kidney bleeding, if taken erratically or not as per the prescription. He also stated that all NSAIDs should be taken only under doctor’s supervision and FDA will closely monitor all the NSAIDs to see if any other has similar side effects.
Vioxx was approved by the FDA in the year 1999. It was mainly used as a pain killer to treat acute pain caused by osteoarthritis or rheumatoid arthritis or during menstrual cycle. It could also be used as a pain killer for treating acute pain in adults. At the time of approval Vioxx was assumed to possess a lower risk of heart related issues, gastrointestinal ulcers and bleeding amongst other new kind of COX-2 selective inhibitor. In fact, Vioxx was the only drug to carry a label stating that it has lower rate of the before mentioned side effects.
Between February 2001 to September 2004, Merck and FDA together studied the side effects of Vioxx and called off the drug. The sequences of events were:
- June 2000- Vioxx Gastrointestinal Outcomes Research was submitted to FDA, which pointed that the patients taking Vioxx were at higher risk of heart problems and gastric troubles than the patients taking naproxen.
- February 2001- Arthritis Advisory Committee was consulted by FDA, regarding the clinical interpretations of VIGOR. After the results were confirmed by the Arthritis Advisory Committee, the labeling on the medicine was changed and the information about the risk of cardiovascular disorders was reflected.
However, the manufacturer Merck, carried on with further clinical trials and in some time informed FDA about its decision to withdraw the medicine.
- September 2004- Merck met FDA and informed that though the side effect called colon polyps caused due to long term use of Vioxx, may have been halted, but has not been completely wiped out. Hence both FDA and Merck decided to pull of the drug on 28th September 2004.
During the process of drug approval and recall, the reputation of both Merck and FDA ran into shambles. As per Dr. Richard Horton, editor of a well reputed medical journal- The Lancet, FDA and Merck together were well versed of the adverse side effects of Vioxx, but did hide the same from the public for a long time. The scandal went up to the level where the authenticity of FDA was put to question. At that time, it was to be believed that FDA was no more working for public safety and benefit, but had become a godfather of the U.S. drug market.