FDA restricts access to drug Accutane Users must register; drug harms fetuses

WASHINGTON – The thousands of Americans who take the acne drug Accutane – and people who prescribe and dispense it – must enroll in a national registry, part of a major government program to tighten access to the medicine that causes birth defects.

The Food and Drug Administration enacted unprecedented curbs Friday in trying to keep Accutane and its generic competitors on the market while ensuring that pregnant women don’t use the risky pills. Critics see it as the drug’s last chance, after two decades of safety warnings and other restrictions failed to end Accutane-damaged pregnancies.

“This is a system that has been long in the works and many would say is long overdue,” said Dr. Sandra Kweder, the FDA’s deputy drug chief. “The responsibility for ensuring that fetuses are not exposed to this medicine is enormous, and is shared by everyone” who takes, prescribes or sells it.

If a woman becomes pregnant while taking the acne drug, her baby can suffer severe brain and heart defects, mental retardation and other abnormalities, even if the mother took only a small dose for a short period. There is a risk for 30 days after stopping the drug.

Under the program, every patient – man and woman – must enroll in the iPLEDGE computerized registry starting Dec. 31 to receive Accutane or generic versions of the drug isotretinoin.

Doctors must register if they wish to continue prescribing the pills. Drugstores and wholesalers also must register in order for the pills’ manufacturers to ship them any supplies.

How does the program work?

All patients seeking a prescription must sign a document informing them of Accutane’s risks, including the possibility that it contributes to depression or suicidal thoughts – a warning on the drug’s label that FDA also strengthened Friday.

Patients must agree to monthly doctor visits for refills and not to share the pills with anyone. Then the doctor registers each patient into the iPLEDGE database, giving him or her a special identifying code number, and writes the prescription.

But for women of childbearing age, there are some additional steps:

-They must undergo two tests to ensure they’re not pregnant in a laboratory or doctor’s office before the initial prescription, and monthly pregnancy testing before each refill. Home pregnancy tests don’t count. The doctor must enter the pregnancy test results into the iPLEDGE system, and the woman must buy her pills within seven days.

-These women also must agree to use two forms of birth control while using Accutane, and must self-register with iPLEDGE – in addition to the doctor’s initial registration – to report that they’re doing so. There’s no way to know if women lie in this step, but FDA sees it as an additional opportunity to warn of the pills’ danger.

The pharmacist must check the computer database before filling a prescription to ensure that patients followed all these rules.