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Correction to This Article
A Dec. 7 Health article about drugs that a Food and Drug Administration official said have underpublicized safety risks incorrectly stated the highest approved U.S. dosage for cholesterol drug Crestor. The highest approved dose is 40 milligrams.

Five Brands of Risk

Now That an FDA Official Has Voiced Concerns About A Group of Popular Medications, Some Patients Who Take Them Are Seeking Safer Options

By January W. Payne
Washington Post Staff Writer
Tuesday, December 7, 2004; Page HE01

It's been a tough couple of weeks for the U.S. Food and Drug Administration (FDA) and pharmaceutical companies. But it's also been difficult for the millions of people who are taking any of five medications cited as potentially dangerous at a Nov. 18 Senate hearing.

That hearing was held to explore the FDA's record on warning people about drug risks. During his testimony, David J. Graham, associate director of the FDA's office of drug safety, said underpublicized safety risks of five drugs -- weight loss medication Meridia; acne drug Accutane; asthma medication Serevent; cholesterol drug Crestor; and painkiller Bextra -- could lead to restrictions or withdrawal of the drugs from the market.

(Gerald Herbert/AP)

More than 15 million prescriptions were filled for the five drugs during the first nine months of this year, according to IMS Health, a pharmaceutical information and health care consulting company. While the makers rigorously defend the drugs' safety when taken as directed, some people who take them are scared.

Michael Miller, director of the Center for Preventive Cardiology at the University of Maryland Medical Center in Baltimore, said at least 10 patients have called asking what to do. While some research suggests that Crestor carries greater risk of serious side effects than other statins, Miller said current knowledge does not warrant taking most patients off the drug. He will continue to monitor patients carefully and won't prescribe Crestor to those at high risk for the most serious side effects.

If you are taking one of these drugs and want to consider another treatment, experts recommend consulting with your doctor before stopping or changing any regimen. Some drugs interact with others, so you should tell your doctor about any drugs -- prescription or over-the-counter -- you're taking on a regular basis.

For those taking any of the five drugs, risks and options are discussed below.

• Meridia Used for weight loss, works by "acting on the appetite control centers in the brain," according to its maker, Abbott Laboratories. The drug works best when combined with a low-calorie diet, the company says.

Risks Elevated risk of cardiovascular side effects, including heart attack and stroke.

Drugmaker Response Illinois-based Abbott says it stands behind the safety of the drug.

Alternatives The best way to drop pounds: Eat less, move more, doctors said. "I very much believe in behavior modification and lifestyle changes," said Tania Heller, medical director of Suburban Hospital's Center for Eating Disorders and Adolescent Obesity. For patients at high risk for complications of obesity -- such as those with type 2 diabetes -- drugs may help speed weight loss, Heller said. "But the key point to get across is not to rely only on medication" to lose weight, she said.

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© 2004 The Washington Post Company


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