FDA Orders Merck to End Vioxx Promotions

The Food and Drug Administration ordered Merck & Co. to cease promotions aimed at getting doctors to prescribe its arthritis painkiller Vioxx, saying they minimize potential safety risks. The FDA told Merck to set the record straight by sending a “Dear Doctor” letter to all health workers who may have been exposed to the misleading campaign. Merck has until Oct. 1 to respond.

The main issue: Whether Vioxx users face an increased risk of heart attacks and strokes. A recent study comparing Vioxx with another painkiller, naproxen, suggested they do.

Many heart experts are divided about the risk and want more research. But an FDA advisory panel has said Vioxx should carry a warning label about the potential risk. Merck has argued that Vioxx falsely looked risky because naproxen thins the blood much like aspirin does and thus protected against heart attacks.

Shares of Merck closed down $1.54 at $62.45 on the NYSE.