Vioxx
On September 30, 2004, Merck announced a worldwide withdrawal of its anti-inflammatory drug, VIOXX(r), following information that people taking VIOXX(r) are two times more likely to have heart attacks and strokes than people who take other inflammatory drugs, such as Naproxen(r).
Vioxx is one of a class of anti-inflammatory drugs strenuously marketed as being more effective, with fewer side effects than other, older drugs, including such over-the-counter medications as ibuprofen.
Vioxx and other drugs in the class have not proven to be the breakthrough cure-all for pain as they were advertised. In fact many physicians prefer ibuprofen for pain relief to Vioxx and Celebrex combined, and for patients, the cost of the over-the-counter medication is 10 to 15 times less than that of the prescription drugs.
Merck & Co., the maker of Vioxx launched the drug in the U.S. in 1999, and has had nearly $2.5 billion in sales of the drug in 2003.
RECALL
On September 30, 2004, Merck & Co., Inc. voluntarily withdrew its arthritis drug, Vioxx, from the worldwide market after new data from a clinical trial found a much higher risk of heart attacks and strokes was attributed to Vioxx use. The subject clinical trial, referred to as APPROVe (Adenomatous Polyp Prevention on Vioxx), was a three-year study aimed at showing that Vioxx at a 25mg dosage prevented the recurrence of colon polyps. However, physicians who were overseeing the clinical trial, referred to as the data safety monitoring board, recommended the study to be halted because of the increased risk of cardiovascular events including heart attacks and strokes. Merck, as well as the Food and Drug Administration (FDA), recommend patients who are currently taking Vioxx to discuss alternative treatments with their health care providers.
The FDA first approved Vioxx in May 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. Vioxx was the second of a new type of non-steroidal anti-inflammatory drug (NSAID) called a Cox-2 inhibitor, (Pharmacia's Celebrex was the first). At the time that Vioxx was approved, the hope was that it would lower the risk of gastrointestinal ulcers and bleeds as compared with standard pain relievers such as aspirin or ibuprofen. However, the FDA mandated that the label for Vioxx include the standard gastrointestinal warning, which aspirin, ibuprofen and other pain relievers are required to use.
In order to apply to the FDA for removal of the gastrointestinal warning, Merck engaged in a study called VIGOR (Vioxx Gastrointestinal Outcomes Research), which compared Vioxx to Naproxen, another common pain reliever. Merck was hoping that the study would show that Vioxx did not have the gastrointestinal side effects of Naproxen. However, when analyzing results of the VIGOR study, Merck found that Vioxx had a four-fold increased risk of cardiovascular events, including heart attacks and strokes, in those patients who took Vioxx instead of Naproxen. These findings were reported to the FDA in June 2000. Given the VIGOR results, the FDA implemented labeling changes to Vioxx to include information about the increased risk of cardiovascular events.
Studies following the VIGOR trial also demonstrated that those patients taking Vioxx are at an increased risk for heart attacks and strokes, including a Merck sponsored trial from Brigham & Women's Hospital in Boston as well as a Kaiser Permanente analysis. The FDA was in the process of reviewing these latest studies to determine what actions to take with regard to Vioxx when Merck's withdrawal announcement was made on Friday, September 30th, based upon the APPROVe trial.
A recent Journal of the American Medical Association report linked Vioxx to
· blood clots
· heart attacks and
· strokes
Vioxx usage has also been associated with other serious side effects such as:
· Stomach problems and intestinal bleeding
· Allergic reactions including swelling of face, lips, tongue, and/or throat which may cause difficulty breathing or swallowing
· Kidney problems, while not common can include acute kidney failure and worsening of chronic kidney failure
· Severe liver problems occur rarely in patients taking NSAIDs
Although these side effects occur rarely, if you believe you are experiencing one of these side effects you should consult your doctor right away.
More common, non life threatening, side effects associated with VIOXX have included:
· Upper and/or lower respiratory infection and/or inflammation
· Headache
· Dizziness
· Diarrhea
· Nausea and/or vomiting
· Heartburn, stomach pain and upset
· Swelling of the legs and/or feet
· High blood pressure
· Back pain
· Tiredness
· Urinary tract infection.
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