FDA Puts New Restrictions on Accutane
Accutane is the most effective drug we have to treat acne, but also the most controversial. The media has been irresponsible at times by reporting stories of questionable side effects and in effect “demonizing” this very safe and useful drug. However, the one side effect that is not in any way “questionable” is that Accutane can cause birth defects and therefore cannot be given to a woman who may become pregnant.
In an effort to eliminate Accutane-related birth defects, the thousands of Americans who take the acne drug Accutane — and people who prescribe and dispense it — must now enroll in a national registry.
Under the program, every patient — men and women — must enroll in the iPLEDGE computerized registry starting Dec. 31 2006 to receive Accutane or generic versions of the drug isotretinoin. Doctors must register, too, 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.
Additional Step for Women:
Women 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 on 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 the FDA sees it as an additional opportunity to warn of the pills’ danger.
The last step occurs at the pharmacy. The pharmacist must check the computer database before filling a prescription to ensure that patients followed all these rules.
The Scope of the Problem:
The FDA estimates that 100,000 prescriptions for Accutane and generics are filled each month. Since Accutane began selling in 1982, the FDA has reports of well over 2,000 pregnancies among users (and possibly more that were never reported). The vast majority ended in abortion or miscarriage, but the FDA counts more than 160 babies born with drug-caused defects.