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Vioxx Gets Green Light To Come Back On Market

Added March 2nd, 2005

The drug that was at the center of a major scandal last year, and was subsequently withdrawn from the market, has been given the go ahead to make a comeback. Vioxx, a drug manufactured by pharmaceutical giant, Merck, was recalled from the market last autumn following evidence that it was linked to increased risk of heart attacks and strokes. However, Food and Drug Administration advisors have stated that, providing the drug carries stringent warnings, it can come back to the market.

The decision to allow Vioxx back onto the market was a narrow one, and the motion won by just two votes. If and when the drug does make a comeback, the FDA panel of advisors have confirmed that a black box warning – the most stringent warning available for drugs – must be used, enabling doctors and patients to see that the drug is associated with dangerous side effects and allowing them to make a more informed decision with regards to whether to prescribe or use it.

Panel members also stated that advertising of the drug should be restricted, as this is thought to be a powerful tool in the rising popularity and use of such drugs, and is thought to have added to the rising need and demand for this type of drug. “We want to send a very strong message that direct-to-consumer advertising is not appropriate,” stated panel chairman, Dr Alastair Wood. “It would be a brave man or a brave company that would start an ad campaign for these drugs.”

Since the FDA is usually known to go with the panel’s suggestions, it is thought that there will be no resistance to the drug being made available again, subject to the restrictions put forward by the panel. However, even panel members are wary of actually taking such drugs, with one members stating: "They would not be my first choice of drugs."

Vioxx Gets Green Light | Printable Version (Opens In New Window)

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