FDA places very tight restrictions on acne drug Accutane

Aug 14 2005

The U.S. Food and Drug Administration said late last week, that in future, patients and doctors will have to register with manufacturers and promise to comply with tight restrictions, before using the acne drug Accutane and it's generic versions.

The measures come after recommendations from an FDA advisory panel in February 2004, calling for tighter limits on Accutane, and in November 2004, veteran FDA scientist David Graham called for a closer scrutiny of five drugs, including Accutane.

This demand will become effective from the end of December, and is part of a plan announced in November last year, to strengthen safeguards to prevent pregnant women from taking Accutane, as the prescription drug can cause severe birth defects or miscarriages.

The move will also mean that wholesalers and pharmacies will have to sign up with manufacturers to obtain the drug as from November 1st.

They will be obliged to follow distribution rules, says the FDA.

Dr. Sandra Kweder, deputy director of the FDA's Office of New Drugs, says the program is an "unprecedented" effort to manage a serious safety concern of a widely used drug.

According to the FDA, about 1.2 million prescriptions per year are written for the drug.

The FDA has also changed it's existing warnings on Accutane in order that doctors and patients can identify depression, suicidal behavior and other psychiatric problems that could occur with the drug's use.

Accutane is also known by the generic name Isotretinoin, which is produced by Mylan Laboratories.

India's Ranbaxy Laboratories and Barr Pharmaceuticals also sell generic versions of the drug.

All manufacturers have expressed support for the new distribution limits, but add that it was unknown if Accutane caused psychiatric problems.

The March of Dimes, which works to prevent birth defects, has welcomed the move but vows to closely monitor its effect.

March of Dimes Medical Director Nancy Green says if the distribution limits fail to prevent pregnancy exposures, they will consider calling for a withdrawal of the drug from the market.

Lawmaker Bart Stupak, a Michigan Democrat, says he is pleased with the FDA action, but he believes the use of the drug for milder acne would "remain rampant" because the FDA cannot limit prescribing to the severe cases the drug is approved to treat.

Stupak, who went public in October 2000 over his son's suicide while taking Accutane, says the FDA should have taken steps to improve the tracking of mental problems among Accutane users.

Although several, but in the main, voluntary efforts have been made since Accutane's approval in 1982 to keep pregnant women from taking it, officials continue to receive reports of pregnancies

The new plan compells women of child-bearing potential, to register with manufacturers, sign consent forms and be counseled about potential risks.

They must also have monthly pregnancy tests before refills are given and promise to use two forms of birth control.

Doctors will be expected to pledge to inform patients of potential side effects and check for negative pregnancy tests, while male patients will need to sign a form saying they were told of Accutane's psychiatric and other risks.