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FDA Launches Site to Warn Patients, Doctors of Drug Risks

May 20, 2005 | Knight Ridder Newspapers

The U.S. Food and Drug Administration has begun issuing alerts to patients and doctors on its Web site about emerging drug-safety concerns, including dangers posed by drugs prescribed for unapproved purposes.

The new site, called Drug Watch, marks a significant change in how the agency communicates risks to the public. In the past, the FDA has spent months or years privately weighing and debating risk information with drug companies until a final determination was made on the scientific significance of the danger.

After being bashed by Congress and consumers for its slow response to emerging information about heart risks posed by blockbuster pain medications such as Vioxx, the FDA now is beginning to make risk information available to the public much sooner.

"This is really a fundamental change," said Dr. Steven Galson, the acting director of the FDA's Center for Drug Evaluation and Research. "We do intend to give companies a heads up before posting something new about their drugs, but we're not going to discuss it with them. They're not going to review it."

The safety alerts posted so far on the site are notable also because they emphasize risks posed by doctors prescribing drugs for purposes never approved by the FDA. It's a practice called "off-label prescribing" because it involves using drugs in ways and to treat conditions not covered by the safety and effectiveness determinations on their FDA-approved labels.

"That's a very important aspect of this," Galson said. "As you know, we don't regulate the practice of medicine. We have no way of preventing physicians from using drugs off label."

But Galson said the agency does have a responsibility to let people know about known risks of off-label uses. "This is very controversial, of course," he said.

Some off-label drug uses are beneficial and based on good science, others have little proof of effectiveness and still others have been proved worthless in studies.

Officials at the American Medical Association, which represents doctors, and the Pharmaceutical Research and Manufacturers of America, which represents drugmakers, declined to comment, saying they are evaluating the Drug Watch site and will submit formal comments to the FDA.

Ed Sagebiel, a spokesman for Indianapolis-based drugmaker Eli Lilly, said the company generally supports the FDA's new effort. The site includes alerts for Eli Lilly drugs Prozac, warning of suicide risks related to it and other antidepressants, and Zyprexa, warning of an increased risk of death when it and other atypical antipsychotics are prescribed off-label to treat dementia in elderly patients.

"We just want, from our standpoint, to properly balance warning people and patients of safety concerns without frightening them or inadvertently making them stop taking their medicines," Sagebiel said.

Galson said others in the drug industry have expressed similar concerns. "They're worried we may be over-warning and dissuading patients from using products that may do good," he said. "We expected we would get that sort of push-back."

Advocates for patients called the site an incremental move in the right direction, even though it requires patients to seek out the information on the Internet, rather than it being given to them when they pick up their medicines. The emphasis on early and off-label risk information is a departure for the FDA, they said.

"I don't think they had the political courage even a few years ago to take these kinds of steps," said Larry Sasich, a pharmacist with Public Citizen's Health Research Group, a consumer watchdog that publishes a searchable database of drug risks at

Sasich said he thinks the FDA is realizing that the only way to change risky prescribing is for consumers to know more about the drugs they take. Changing the official labeling on drugs and sending letters to doctors about new risks hasn't worked, he said.

Sasich expressed concern that elderly patients who are the biggest consumers of prescription drugs won't have enough access to Drug Watch information that's available only on the Web.

Cynthia Pearson, the executive director of the National Women's Health Network in Washington, praised the direct communication of risks listed atop several drugs on the site.

"Our position always has been: Get people access to good information and they can make good decisions," Pearson said.

The Drug Watch site, still being developed, lists information on about 200 drugs. Most of them include routine prescribing information. Among those tagged with an "FDA Alert:"

Accutane, a drug for severe acne. "The FDA continues to assess reports of suicide or suicide attempts" associated with this drug. All patients "should be observed closely for symptoms of Accutane depression or suicidal thoughts," the alert warns.

Cytotec, also called misoprostol, a drug approved to prevent ulcers. The alert warns of risks in its off-label use in labor and delivery. "These uses are not approved by the FDA. No company has sent the FDA scientific proof that (Cytotec) is safe and effective for these uses. There can be serious side effects, including a torn uterus..." the alert warns.

Zyprexa, Risperdal and several other psychiatric drugs called atypical antipsychotics. The FDA warns that when prescribed off label as a treatment for dementia, older patients "had a higher chance for death than patients who did not take the medicine."

Amiodarone, marketed also as Cordarone and Pacerone, a popular heart drug approved only to treat a specific life-threatening rhythm disorder. It is widely prescribed off label for non-life-threatening atrial fibrillation. The alert warns of potentially fatal side effects including lung toxicity, liver injury and worsened heart rhythm problems.

Gabitril, a drug approved to treat seizures. The alert warns that it risks causing seizures when used off label. Gabitril's "safety and effectiveness have not been established for any other use," the alert notes, adding that the drug's maker, Cephalon, will be educating doctors "to discourage off-label use."

Sheryl Williams, a Cephalon spokeswoman, said through Drug Watch, the FDA appears to be trying to do a better job of communicating and addressing the increasing prevalence of off-label prescribing.

A Knight Ridder investigation published in 2003 found that patients are being injured and killed when doctors routinely prescribe medications in ways that the FDA has never approved as safe and effective. Off-label prescriptions for top-selling drugs accounted for nearly a quarter of their retail sales.

Williams said most of the prescriptions that doctors write for Gabitril are to treat psychiatric conditions - not epileptic seizures. Bipolar disorder is a particularly popular use, she said.

"The problem is there is no guidance for them to do so. We haven't done double-blind studies. We haven't even done single-blind studies," Williams said. "Our scientific team doesn't believe there is sufficient evidence that a drug like Gabitril would be effective in bipolar disorder."

While Gabitril is effective in reducing the frequency of seizures in people with epilepsy, she said, when used off label the drug has been associated with seizures in people without epilepsy.

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