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How Safe Are the 5 Drugs?

FDA, pharmaceuticals defend process after insider names questionable medications

FRIDAY, Nov. 19, 2004 (HealthDayNews) -- Now that a U.S. Food and Drug Administration official has named five prescription drugs that may pose health dangers like Vioxx, medical professionals are taking sides as the debate is joined. And right now, there appears to be as many questions as there are answers.

Testifying before a Senate Finance Committee hearing Thursday, FDA safety reviewer Dr. David Graham singled out the acne drug Accutane, the weight-loss drug Meridia, the cholesterol-lowering agent Crestor, the pain reliever Bextra, and the asthma drug Serevent.

Graham stated that due to potential risks, the five drugs need "to be seriously looked at."

Graham was an early critic of Vioxx, an arthritis and pain drug. In September, the manufacturer, Merck & Co., Inc., announced it was voluntarily removing the drug from markets worldwide after its own research found long-term users faced increased risks for heart attack and stroke.

Following Graham's testimony Thursday, the makers of the five other drugs defended their products as safe.

Most of the drugs have controversial histories, some louder than others. But not all doctors agree that all the drugs should be banned. In many cases, some of the drugs' benefits outweigh potential risks -- if the medicines are prescribed properly and the patients carefully monitored.

Accutane, for instance, has a long record of scrutiny since it first reached the market in 1982. The drug 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 and actions. Federal lawmakers, led by U.S. Rep. Bart Stupak (D-Mich.), have been pressuring the FDA to require that users and prescribers of the drug enroll in a national registry; some legislators want the drug banned. Bartak's son committed suicide in 2000 while taking the drug.

But many physicians believe that Accutane is a valuable medicine.

"There are many people who have acne who will not respond to any topical acne treatment, and will not respond to oral antibiotics," said 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."

The vast majority -- 85 percent -- of people who take Accutane will have their acne clear up, Jamal added.

The drug does require extreme diligence when prescribing and using it, however, Jamal said. 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.

"I think when those issues have been addressed adequately, the drug can be safely prescribed," Jamal said. "I do think Accutane has an important place in the treatment of severe and scarring acne and, right now, I don't see anything else that could replace that."

Graham's comments Thursday surprised even seasoned observers such as Public Citizen, a nonprofit consumer advocacy organization.

"We thought the focus [of the hearing] was going to be on Vioxx," said Larry D. Sasich, a pharmacist and research analyst for Public Citizen. "I was in the room. There was an audible gasp and, after the gasp, the Blackberries started to burn."

Sasich said Public Citizen agreed with Graham on Accutane. "The distribution needs to be severely restricted," he said. "We feel that it is uniquely useful for a rare condition called cystic acne [which leads to severe scarring]."

Crestor, a drug designed to lower cholesterol, has been the subject of great scrutiny as well. Public Citizen lobbied against its approval, and has since been urging the FDA to pull it off shelves, alleging that patients who use it are 75 times likelier to suffer 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," said company spokeswoman Emily Denney. "We are very confident in the safety profile of Crestor, and we've got all of our clinical and postmarketing information available online. It's all out there for everyone to see."

Public Citizen has also called on the FDA to ban Meridia, the 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, and so here's a drug with no proven benefit from a health standpoint and it has some substantial risks," Sasich said. "We think this is one that should come off the market."

Abbott Laboratories, the maker of Meridia, insists that it's safe. "Obesity remains one of the leading health epidemics in the U.S., 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 percent or more of body weight," the company said in a statement.

Bextra -- like Vioxx, a member of a class of stomach-friendly painkillers called cox-2 inhibitors -- has also been linked to potentially serious heart problems. According to results of a study released at the American Heart Association's annual scientific sessions earlier this month, Bextra users with heart disease had double the risk of heart attack and stroke, compared to nonusers.

Bextra's maker, Pfizer, Inc., dismissed the study's conclusions. "Bextra has been found safe and effective when used as indicated to treat osteoarthritis, rheumatoid arthritis, and pain due to menstruation," the company said in a statement.

"In addition, no increased risk of serious cardiovascular events was seen in a recent pooled analysis of nearly 8,000 osteoarthritis and rheumatoid arthritis patients treated with Bextra for periods ranging from six weeks up to one year," the company said.

Meanwhile, the FDA's top officials on Friday defended the agency's drug-review process, saying they took all possible steps to ensure the public's safety.

"Dr. Graham's congressional testimony does not reflect the views of the agency," Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, said in a statement.

"The five specific drugs that Dr. Graham identified in his oral testimony are currently approved as safe and effective for use in the United States. 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 said.

More information

Visit the FDA for more on recent drug safety and withdrawal actions.

SOURCES: Sumayah Jamal, M.D., Ph.D., assistant professor of dermatology, New York University School of Medicine, New York City; Larry D. Sasich, M.P.H., PharmD., research analyst, Public Citizen, Washington, D.C.; Nov. 18, 2004, statement, Steven Galson, M.D., acting director, Center for Drug Evaluation and Research, U.S. Food and Drug Adminstration, Rockville, Md.
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