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FDA Revises MS Drug Warning

Mar 14, 2003 | UPI

The U.S. Food and Drug Administration and the manufacturer of a multiple sclerosis drug called Avonex issued a new alert on the medication Friday to warn healthcare professionals about risks of mental disorders.

Biogen, the international pharmaceutical company that makes Avonex, and the FDA said they have agreed on a patient medication guide for physicians and new safety information about the drug's associated risks of depression and severe psychiatric problems among patients who have a prior history of these illnesses.

The FDA-approved guide on Avonex includes warnings of depression, feelings of suicide, development of new or worsening pre-existing psychiatric problems, autoimmune disorders, suffocation, hepatitis risks, and even changes in the blood. All of the information has been added to the labeling.

"Avonex can cause serious side effects," the FDA said in a statement, so patients should discuss with their doctors the risks associated with this drug.

Although Avonex does not cure MS, the FDA said it has been shown in clinical studies to reduce flare-ups. The drug belongs to a class of medications called interferon beta-1a.

"I don't want the MS community to be alarmed by this," Dr. Ben Thrower, medical director of the Multiple Sclerosis Center at the Shepherd Center in Atlanta, a non-profit hospital specializing in catastrophic care, told United Press International. "The risk of depression is probably dose-dependent," Thrower said. "We do see some with Avonex. It's some, but not a lot."

Thrower explained Avonex was not required previously to carry such a warning about psychiatric problems, but because other interferon beta-1a medications have been linked to such risks, "the FDA probably thought it should be a class effect."

Representatives from Biogen did not return UPI's requests for comment by presstime.

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