The VIOXX recall and what it means to you
11/19/2004 Much has been written lately about the prescription, non steroidal anti-inflammatory drug Vioxx (rofecoxib) since its voluntary recall by its manufacturer, Merck & Company. Following the recall, the Food and Drug Administration issued a Public Health Advisory to inform patients of this action and to advise them to consult with a physician about alternative medications.
Merck’s decision to withdraw Vioxx from the market came after the data safety monitoring board overseeing a long-term study of the drug recommended that the study be halted because of an increased risk of serious cardiovascular events, including heart attacks and strokes, among study patients taking Vioxx compared with patients receiving placebo. The study was being done in patients at risk of developing recurrent colon polyps.
The FDA approved Vioxx in 1999 for the reduction of pain and inflammation caused by osteoarthritis, as well as for acute pain in adults and for the treatment of menstrual pain. It was the second of a new kind of NSAID (Cox-2 selective) approved by the FDA. Subsequently, the FDA approved Vioxx to treat the signs and symptoms of rheumatoid arthritis in adults and children.
At the time that Vioxx and other Cox-2 selective NSAIDs were approved, it was hoped that they would have a lower risk of gastrointestinal ulcers and bleeding than other NSAIDs (such as ibuprofen and naproxen). Vioxx is the only NSAID demonstrated to have a lower rate of these side effects.
In June 2000, Merck submitted to the FDA a safety study called VIGOR (Vioxx Gastrointestinal Outcomes Research) that found an increased risk of serious cardiovascular events, including heart attacks and strokes, in patients taking Vioxx compared with patients taking naproxen.
After reviewing the results of the VIGOR study and other available data from controlled clinical trials, the FDA consulted with its Arthritis Advisory Committee in February 2001 regarding the clinical interpretation of this new safety information. In April 2002, the FDA implemented labeling changes to reflect the findings from the VIGOR study. The labeling changes included information about the increase in risk of cardiovascular events, including heart attack and stroke.
Recently other studies in patients taking Vioxx have also suggested an increased risk of cardiovascular events. The FDA was in the process of carefully reviewing these results, to determine whether further labeling changes were warranted, when Merck informed the agency of the results of the new trial and its decision to withdraw Vioxx from the market.
Merck contacted the FDA on September 27, 2004, to request a meeting and to advise the agency that the long-term study of Vioxx in patients at increased risk of colon polyps had been halted. Merck and FDA officials met the next day, September 28, and during that meeting the company informed the FDA of its decision to remove Vioxx from the market voluntarily.
Stay informed and keep up with changes in the law that impact you and your rights.
- 10/25/2004 News article link
- 07/29/2004 News article link
- 07/06/2004 News article link
|