U.S. tightens safety rules for acne drug

People in the U.S. who take the acne drug Accutane will need to add their names to a national registry. The new safety measure aims to prevent birth defects related to the drug.

The registry is one of the new safety measures introduced by the U.S. Food and Drug Administration on Friday. The rules apply to the drug isotretinoin in its brand name and generic forms.

The medication is supposed to be prescribed for severe acne, but has been used to treat milder cases.

• FROM FEB. 26, 2004: Boost training for doctors prescribing acne drug: researcher

The other measures require patients to:

• Fill out an informed consent form.
• Obtain counselling about the risks and requirements for safe use of the drug, which can contribute to depression or suicidal thoughts.
• Book monthly doctor visits for refills.
• Agree not to share pills.
• Take birth control counselling and pregnancy tests for women of childbearing age.

The U.S. regulator is also changing warnings on the drugs to help patients and doctors identify and manage potential psychiatric side-effects.

Doctors prescribing the drug will need to register in the system, inform patients of potential side-effects and check that pregnancy tests are negative.

Pharmacists will be required to check the computer database to ensure patients are following the rules.

The March of Dimes, which works to prevent birth defects, applauded the FDA's new safety moves, noting there were at least 2,000 exposed pregnancies since the drug went on the market.

All manufacturers of the drug are participating in the program. Previously, safety measures were voluntary.

The U.S. registry opens on Aug. 22 and becomes mandatory on Dec. 31.