Friday, September 17, 2004

Warning about off-label prescriptions?

A panel advising the Food and Drug Administration (FDA) recommended a black box warning for non-FDA approved uses and marks a significant shift in the government's regulatory stance toward widely used antidepressants -- which include Prozac, Paxil, Zoloft and Celexa -- for treating children with depression, anxiety, obsessive-compulsive disorder or other conditions.

The issue of patent infringement wherein the majority of prescriptions were for off-label uses came up in the Neurontin case.

from the Washington Post-->

The panel had to wrestle with a problem unique to psychiatry: Depression is itself associated with suicide, and many specialists believe the drugs reduce the risk.

While there is no conclusive evidence of this, studies have shown that suicide rates dropped among populations of children as the prescribing of antidepressants increased. Some experts believe the medications, many of which belong to a class of drugs called selective serotonin reuptake inhibitors, or SSRIs, may increase the risk of suicide among some children while reducing it in others.

"If there were no SSRIs, would there be more suicides, fewer suicides or the same number of suicides in children?" panel member Norman Fost, professor of pediatrics and bioethics at the University of Wisconsin Medical School, asked at the start of yesterday's session.

Robert J. Temple, the FDA's associate director for medical policy, said there are no data to answer that question.

But most of the panelists agreed that the enthusiasm for the drugs among American physicians was not supported by the research. Many noted with concern that with the exception of Prozac, none of the antidepressants have been approved by the FDA for treating depression in children. Most children are prescribed the medications "off label" -- based on physicians' belief that the drugs are safe and effective. Once a drug has been cleared for the market, physicians are free to use it even for conditions not specifically endorsed by the agency.

The panel's recommendation, on a 15 to 8 vote, left the FDA in the potentially awkward position of having to warn physicians about using the drugs for purposes that the agency has not approved.

While the agency traditionally avoids telling doctors how to practice medicine, many panel members argued that drug marketing was superseding science: Although companies cannot promote most of the antidepressants for childhood depression -- an unapproved use -- they can aggressively market the same medications for adults.

The experts noted that although Prozac is the only drug specifically approved to treat depression in children, the top-selling antidepressant for youngsters is Zoloft. Two trials of Zoloft failed to show the medication was superior to sugar pills in depressed children.

Prozac is no longer being actively marketed because its patent has expired; Zoloft is still being promoted.

Temple said the FDA would weigh whether to include specific information on each drug's label detailing how the drug had performed in clinical trials


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