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FDA tightens restrictions on acne drug



14th August, 2005: U.S. officials said on Friday that patients and doctors must register with manufacturers and promise to comply with tight restrictions on Roche Holding AG's acne drug Accutane and generic versions.

The restriction which will take effect on December 31 is part of a plan announced in November 2004 to strengthen safeguards to restrict pregnant women from taking Acutane. Use of this drug may lead to birth disorders or miscarriages, if taken by pregnant women.

The Food and Drug Administration said that the wholesalers and pharmacies should sign up with manufacturers to get the drug from November 1 and pledge to follow distribution rules.

The program is an "unprecedented" effort to manage a serious safety concern of a widely used drug, said Dr. Sandra Kweder, deputy director of FDA's Office of New Drugs. The F.D.A said that about 1.2 million prescriptions are written per year for the drug.

F.D.A changed the existing warnings on Acutane, so that doctors and patients could better identify depression, suicidal behavior and other psychiatric problems that may occur as a result of the use of the drug.

Accutane is also called by the generic name isotretinoin. Mylan Laboratories Inc.  India's Ranbaxy Laboratories Ltd. and Barr Pharmaceuticals Inc. sell generic versions.

All the drug manufacturers said in a statement that they supported the new distribution limits. They also said it was unknown if Accutane caused psychiatric problems.

"If this does not prevent pregnancy exposures, we would consider calling for a withdrawal of the drug from the market," March of Dimes Medical Director Nancy Green said. The March of Dimes works to prevent birth defects. They welcomed the new rules and said that it would closely monitor the effect.

Several voluntary attempts have been made to keep pregnant women from using the drug , but the officials kept on getting reports of pregnancies. The drug was introduced in 1982.

Under the new law, women of child-bearing potential should register with the manufacturers , sign consent forms and be counseled about risks. They must have monthly pregnancy tests to get refills and promise to use two forms of birth control.

The new plan insists that the doctors must pledge to inform patients of possible side effects and check for negative pregnancy tests. Male drug users should sign a form saying that they have been told of the potential risks in using the drug.

The new restrictions follow the report of an advisory panel set up in February 2004 for tighter limits on Acutane.

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