The Food and Drug Administration announced that Vioxx - Merck's blockbuster painkiller, would include new information on its label. The FDA said that Merck can claim that Vioxx has fewer gastrointestinal complications than one older non-steroidal anti-inflammatory drug, naproxen. But the FDA also decided that the Vioxx label must mention that it might be linked to an increased risk of heart attack or high blood pressure.
Manufacturer Merck & Company got good news, too: Vioxx can advertise that it's gentler to the stomach than an older competitor and that it relieves the pain of rheumatoid arthritis in addition to the more common osteoarthritis. Vioxx and another popular competitor, Celebrex, work differently than older, cheaper painkillers known to cause stomach ulcers.
AdvertisementMerck had fought for over a year to be allowed to say Vioxx is gentler to the stomach. Finally, the FDA agreed that an 8,000-patient study found Vioxx users had half the risk of ulcers as users of the older naproxen. The same study found Vioxx users had twice the risk of heart attacks or other cardiovascular side effects than naproxen patients.
Merck argued that Vioxx isn't bad, but that naproxen offered the added benefit of thinning the blood a little, which Vioxx doesn't do. Studies also show Vioxx can increase the risk of high blood pressure, and that people who use higher-than-recommended doses are more at risk for certain side effects.