Acne drug program targets birth defect prevention
(CNN) -- It's considered one of the most effective treatments for acne, but the drug Accutane also can cause severe birth defects.
Now its manufacturer, Hoffmann-La Roche, is helping implement a program aimed at ensuring that women aren't pregnant -- and don't become pregnant -- while they're being treated.
"The most important thing is that the drug should not be given to anybody who is pregnant," said Dr. John Strauss, professor emeritus of dermatology at the University of Iowa.
Accutane primarily is used to treat severe cases of nodular or cystic acne that aren't responding to other treatments, and dermatologists consider it one of their top weapons against the skin condition.
"Frankly, if I ever get into a situation where I don't have the drug available, I don't know whether I'm going to continue to take care of acne patients," said Strauss, a consultant who reviewed the program for Roche.
But Accutane's risk of causing birth defects has been known since it was initially marketed, the manufacturer says. In addition to the risk of premature birth or miscarriage, it can cause internal and external abnormalities in the fetus.
The program, called SMART (System to Manage Accutane Related Teratogenicity), is an enhanced version of a previous education program for women on the medication. It's being phased in over several months, and April 10 is the deadline for compliance.
To get an Accutane prescription, a female patient will have to have two negative pregnancy tests and commit to using two forms of birth control starting one month before treatment through a month after stopping.
She also has to read and sign a consent agreement explaining the risk of birth defects associated with the drug.
Women must have a negative pregnancy test and get contraception counseling from the prescribing physician before getting a new prescription. Yellow Accutane qualification stickers then will be placed on the prescription, and only prescriptions with stickers attached are to be accepted.
"I think that Roche has really developed a model program for this type of thing," Strauss said. "The amount of effort they put into developing this has been tremendous."
Accutane Information Page - Center for Drug Evaluation and Research
Accutane Medication Guide - Center for Drug Evaluation and Research
Roche U.S. Pharmaceuticals: Accutane
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