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FDA Accutane Panel Says to Loosen Restrictions, Despite Risk of Birth Defects

Aug 3, 2007 | Parker Waichman Alonso, LLP

Despite the fact that Accutane and other isotretinoin-containing medicines are still being used by pregnant women, a Food and Drug Administration (FDA) advisory panel recommended loosening restrictions on the drugs.  Accutane and other drugs in its class are used to treat acne. However, these medications pose a substantial risk of birth defects if taken by pregnant women.

Just days before the FDA advisory panel made its recommendations, a report was released showing that the FDA’s iPledge program was not entirely successful in keeping the drug from expectant mothers.  The iPledge program, which became mandatory last year, requires that all patients sign a document informing them of the drug’s risks.  Patients must also agree not to share their medication with anyone else, and to make follow up visits with their doctors.  The program has special requirements for women of childbearing age, including the requirement that they submit to regular pregnancy tests at their doctor’s office.  The prescribing physician is then required to enter the results of the tests into the iPledge database.  Women also must sign a pledge promising to use birth control while taking Accutane.  In its first year, 122 women in the iPledge program were either pregnant when they started taking Accutane, or became pregnant while doing so.  In some cases, the pregnancy test the women took prior to getting their Accutane prescription had a false-negative reading. In two cases, the women actually convinced their doctor to enter fake test results into the iPledge database.  But most of the pregnancies were the result of contraceptive failure.

The FDA advisory panel wants to lift some of the restrictions of the iPledge program.  For example, under current rules a woman must have a pregnancy test and fill her Accutane prescription within seven days of seeing her doctor.  The panel wants to change the rule so that a patient can get an Accutane prescription within seven days of the test.  Another rule change would allow a patient to have a second pregnancy test and receive a new prescription if she misses the seven day window.  Currently, if a patient does miss that window, they must wait 23 days to take another test before getting Accutane. 

The panel also suggested that the iPledge program should encourage Accutane users who do become pregnant to provide the FDA follow-up information on their pregnancies.  Of the 122 women who became pregnant, only about a dozen supplied such information. The FDA panel criticized a questionnaire the iPledge program used for this purpose, saying that it had a “punitive” tone.  For instance, the panel did not like the way questions about educational background followed those about contraceptive failure.  According to an Associated Press report, one panel member said that the questions implied that a woman became pregnant because she was “stupid”.

The FDA panel said that the proposed rule changes are minor, and should not affect pregnancy rates among Accutane users. They maintained that the alterations would make compliance easier.   

In addition to birth defects, Accutane has been linked to Inflammatory Bowel Disorder, as well as psychiatric problems.  Accutane has also been associated with problems of the liver, kidneys, central nervous system, and pancreas, as well as the cardiovascular, musculoskeletal and auto-immune systems.  Accutane and the other drugs in its class are only supposed to be used for the most severe types of acne.  However, it has long been known that doctors prescribe these medications to patients with milder acne.