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FDA Safety Changes: Mobic
Since Celebrex and Vioxx are back in the news, we thought it would be helpful to recall some of the recent research on these drugs in relation to other NSAIDS that are taken by millions of Americans.
On August 11, the FDA approved safety labeling revisions for the nonsteroidal anti-inflammatory (NSAID) drug meloxicam (Mobic tablets and oral suspension, made by Boehringer Ingelheim, Inc) to advise of contraindications and warnings associated with this class of drugs.
The FDA also emphasized the importance of minimizing NSAID therapy to the lowest effective dose for the shortest possible duration consistent with individual patient treatment goals. In patients at high risk for cardiovascular (CV), gastrointestinal (GI), or renal effects, treatment options that do not involve NSAIDs should be considered.
Clinical trials of up to 3 yearsí duration have linked several cyclooxgenase 2 (COX-2) selective and nonselective NSAIDs to an increased risk for serious and potentially fatal CV thrombotic events, myocardial infarction (MI), and stroke. According to the FDA, all NSAIDs may have similar risks that increase with duration of use and in the presence of existing CV disease and/or related risk factors. [Ed: emphasis added]
Physicians are advised to remain alert for the development of CV events, even in the absence of previous symptoms. The FDA notes that there is no consistent evidence that concurrent use of low-dose aspirin mitigates the risk for thrombotic events, and concomitant use of both drugs does increase the risk for serious GI events.
In other words, we still donít know all that we need to know about the baseline safety issues involved in long-term NSAID use. Ironically, the development of Cox-2 drugs was spurred by gastrointestinal safety concerns over older NSAIDS, which eventually led to new concerns regarding cardiovascular safety after the withdrawal of Vioxx. Medical research, as much as any other human enterprise, is ruled by the law of unintended consequences. Unfortunately, American medicine is also subject to a tort system that can penalize companies based on 20/20 hindsight. In the long run, this distorts safety incentives by discouraging companies from aggressively pursuing potential safety concerns in a postmarket environment.
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