Tioxx isn't the only drug that may have posed a danger to those who used it. A US Food and Drug Administration (FDA) official cites some other prescriptions that need to be "seriously looked at."
These include the acne drug Accutane, the cholesterol-lowering medication Crestor and the weight-loss drug Meridia, according to FDA safety reviewer Dr. David Graham, an early critic of Vioxx, the arthritis and pain medication that was voluntarily removed from the marketplace in September 2004 after its manufacturer's own research found that long-term users faced increased risks for heart attacks and strokes.
Although some doctors believe the drugs cited by Graham should be banned, others say that their benefits outweigh potential risks—if the medicines are prescribed properly and the patients carefully monitored.
Accutane
Accutane is known to cause birth defects when taken by pregnant women, and there have also been allegations that it can cause psychiatric problems—including depression and suicidal thoughts. Federal lawmakers, led by US Rep. Bart Stupak (D., Mich.), whose son committed suicide in 2000 while taking this medication, have been pressuring the FDA to require users and prescribers of Accutane to enroll in a national registry. Some legislators want the drug banned.
But many physicians believe that Accutane is a valuable medicine because it clears acne in 85% of the people who take it. "There are many people who have acne who will not respond to any topical acne treatment, and will not respond to oral antibiotics," says Dr. Sumayah Jamal, an assistant professor of dermatology at New York University School of Medicine, "When I see a young person who is socially debilitated as a result of the acne, and when I see it is scarring acne, I will advise them of their treatment options and Accutane is one of those options."
However, the drug does require extreme diligence when prescribing and using it, Jamal notes. Adhering to recommended practice, she requires all female patients of childbearing age to use two forms of birth control and to come in once a month for a pregnancy test before getting a refill prescription. She also informs all patients of the possible psychiatric side effects.
Crestor
Crestor, a drug designed to lower cholesterol, has been the subject of great scrutiny as well. Public Citizen, a consumer advocacy group, lobbied against its approval, and has since urged the FDA to pull it off shelves.
Public Citizen alleges that patients who use it are 75 times more likely to have kidney damage than patients using any other drug in this family of statins.
The drug's maker, AstraZeneca, defends its record. "We have been assured today by officials at senior levels of the FDA that there is no concern in relation to Crestor's safety," says company spokeswoman, Emily Denney. "We are very confident in the safety profile of Crestor, and we've got all of our clinical and post-marketing information available online. It's all out there for everyone to see."
MERIDIA Public Citizen has also called on the FDA to ban Meridia, a weight-loss drug, saying it is "minimally effective and has been associated with several deaths.
"Meridia, in some people, raises blood pressure and heart rate. So here's a drug with no proven benefit from a health standpoint and it has some substantial risks," says Larry D. Sasich, research analyst for Public Citizen. "We think this is one that should come off the market."
Abbott Laboratories, the maker of Meridia, insists that it is safe. "Obesity remains one of the leading health epidemics in the US, and Meridia is one of the few effective drugs that are currently available for the treatment of obesity. People who benefit from Meridia can lose up to 10% or more of body weight," the company says.
FDA Defense
Dr. Steven Galson, the acting director of the FDA's Center for Drug Evaluation and Research, defends his organization. "The FDA evaluates the safety and effectiveness of all drugs independently on a case-by-case basis before they are approved to enter the marketplace, and also evaluates reported adverse events with all drugs already on the market to assess whether unforeseen safety concerns need to be addressed," he says.
