The FDA’s reasons to recall the popular painkiller Bextra from the marketplace were, in short, that the risks of cardiovascular (CV) events (e.g. – heart attack and stroke) and serious skin reactions were relatively high. The total number of people who experienced these serious side effects was small, but the percentage was high enough to outweigh the benefits of the pain-reliever drug. The risk of CV events for Bextra was high, but no higher than that of other nonsteroidal anti-inflammatory drugs (NSAIDs) – a problem which has prompted the FDA to instruct all makers of NSAIDs such as Advil, Aleve, etc., to post more detailed warnings about the risks on medicine labels. The risk of serious skin reactions, however, was greater than that of other NSAIDs. This increased risk coupled with the fact that Bextra’s positive effects were no more significant than those of any other NSAID, led to the assessment that the risk-benefit profile was unacceptable, which led to the Bextra drug recall.
The Bextra recall was based on several sets of data. Bextra’s increased CV event risk was established from two short-term trials in patients recovering from coronary artery bypass surgery. As for skin reactions, the FDA’s spontaneous reporting system for these skin reactions reported a much higher rate for Bextra than for other dugs in the same class. Lastly, as for the positive effects of Bextra, studies showed that its gastrointestinal (GI) safety, overall efficacy, and efficacy in patients who were resistant to other medications, all showed no advantage over any other NSAID.
The Bextra drug recall did not occur in a vacuum. Before Bextra, Vioxx, another COX-2 inhibitor NSAID that was also prescribed for arthritis-related pain and inflammation, was pulled from the market for unacceptable CV risk among other things. As more information about the risks and hazards of these COX-2 inhibitors is available and its users become injured, you can expect to see an influx of lawsuits. As with Vioxx, there are Bextra law firms that are knowledgeable in Bextra litigation. See the sections below on How to Find a Lawyer for more information about Bextra law firms and lawsuits.