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FDA issues an advisory on COX-2 inhibitors
Candace Hoffmann, First Word
12/23/2004
The FDA on Thursday issued a public health advisory summarising its recent recommendations for NSAIDs, including COX-2 selective agents, Bloomberg and other news sources report. The agency said the advisory is an interim measure to give physicians a guideline until a panel of independent experts review the safety of these drugs in February.
For the independent review, the FDA said it is collecting and will analyse data from the most recent studies on naproxen, Merck's Vioxx, and Pfizer's Celebrex (celecoxib) and Bextra (valdecoxib), as well as other data to determine if it needs to take regulatory action on the drugs.
The agency also announced that it is requiring evaluation of all prevention studies that involve Celebrex and Bextra to ensure that adequate precautions are implemented in the studies, the news sources report.
In the meantime, the agency advised physicians to limit prescribing Celebrex and Bextra as regulators review data on the drugs, news sources report.The risks and benefits of Celebrex and Bextra, the FDA said, must be weighed, so that they are only prescribed for patients for whom they are appropriate, as reported in news sources.
"FDA is issuing an advisory because of recently released data from controlled clinical trials showing that the COX-2 selective agents (Vioxx, Celebrex and Bextra) may be associated with an increased risk of serious cardiovascular events (heart attack and stroke) especially when they are used for long periods of time or in very high risk settings (immediately after heart surgery," the FDA said in its press release, as reported by CNN Money and other news sources.
For some analysts the FDA's action doesn't appear very strong, nor did it come as a surprise. "This is telling physicians to do what they are already doing -- there's no meat to this,'' First Investors' Steven Sean Hill is quoted by Bloomberg as saying. "The likelihood of a strong FDA reaction was greater than 50 percent before, and this press release did nothing to change the environment.''
"The import of this meeting in February has grown, and they may need to act as a reassuring factor to get everybody away from the hysteria they are in at the moment,'' Washington Analysis' Ira Loss is quoted by Bloomberg as saying. "The statements today are more political than they are scientific.''
The FDA's John Jenkins said that so far, the agency has not determined if any additional regulatory action is needed in regard to Celebrex or Bextra. Vioxx was pulled from the market in late September. "We feel we need an opportunity to fully evaluate the emerging information," he is quoted by Bloomberg as saying.
More information can be found here: FDA Issues Public Health Advisory Recommendations
Despite having been used for decades, most of the non COX-2 NSAIDS have not been evaluated for cardiovascular safety in studies similar to the enormously large multi-year studies of Vioxx, Celebrex and Bextra. Lack of data on cardiac risks associated with these older NSAIDs does not necessarily mean they are safer.
In fact, on December 20, 2004 the National Institutes of health (NIH) reported new information from a long-term Alzheimers prevention study which compared Celebrex to the over-the-counter dose of the common NSAID Naproxen (at a dose of 440 mg/day). In a preliminary analysis, there was an increase in cardiovascular risk in the patients taking the presumed safe naproxen, but not in patients taking 400 mg per day of Celebrex. The take away message: If you don't need these drugs, don't take them. Don't substitute older over-the-counter (OTC) NSAIDS for the COX 2 Inhibitors assuming that they are safer. If you must take these OTC medications, be sure to discuss this with your physician or health care professional, especially if you are taking them for over 10 days.
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