The Bextra debate
Bextra was only sold in 10 mg dosages. However, in a large multicenter, randomized, double-blind, placebo-controlled study of people with moderate to severe osteoarthritis of the knee, 5 mg of Bextra was significantly superior to placebo over the 12-week study. In a multicenter, randomized, double-blind study of people with osteoarthritis of the hip, 5 mg of Bextra was significantly superior to placebo over 12 weeks of study.
Does Bextra come with warning information?
Bextra warning statements have already been included in Bextra labeling information. Bextra causes rare but serious skin diseases in some patients who take it. Bextra warning statements indicate that Bextra side effects may include Stevens-Johnson syndrome, a rare skin condition characterized by a severe inflammatory eruption of the skin and mucous membranes. Toxic epidermal necrolysis is also a potential side effect of taking Bextra. This skin condition causes large portions of the skin to become red and peel in the manner similar to a second degree burn. Bextra warnings also caution that Bextra can cause severe allergic reactions in some patients, including anaphylactic shock.
What prompted the recall of Bextra?
Bextra warning statements regarding cardiovascular safety follow the recent Vioxx recall that occurred on September 30, 2004. The recall was prompted by research findings indicating that patients taking Vioxx for eighteen months double their risk of suffering from a serious heart attack or stroke. Because Bextra, like Vioxx, is a COX-2 selective nonsteroidal anti-inflammatory drugs and because it is so similar to Bextra in its actions on the body, warnings were raised regarding the safety of Bextra and all other COX-2 selective NSAIDs.
Side effects of Bextra
In addition to potential cardiovascular risks, there are other serious Bextra safety issues that have been well known for some time. Bextra safety is compromised in patients who are taking other medications such as aspirin, anti-convulsants, warfarin, and oral contraceptives. The most serious well established Bextra safety risk is the potential development of serious skin diseases.
Bextra and the FDA
Bextra stroke, heart attack, and fatal skin condition risks were among the most serious side effects which prompted the Bextra recall. Bextra enjoyed about a three year stay on the market before being pulled from the shelves, yet knowledge of its serious side effects began surfacing soon after its 2001 FDA approval. As early as 2002, the FDA requested that Pfizer add stronger warnings to its Bextra labeling about serious skin side effects.