Accutane pregnancy warnings ignored

Despite warnings and information regarding Accutane’s detrimental effect on fetuses, women are still becoming pregnant while taking it. According to an August 17, 2001, FDA press release, the Centers for Disease Control and Prevention (CDC) reported “that despite prevention efforts some women who take Accutane, a prescription medication given for severe acne and known to cause birth defects, still become pregnant while on this medica­tion.” The CDC also reported that a symbol intended to remind women that they must not get pregnant while taking these medications is commonly misinterpreted. The two studies, “Continued Occurrence of Accutane-exposed Pregnancies” and “Interpretations of a Teratogen Warning Symbol,” were published in Teratology (2001, volume 64, issue 3, pages 142-147 and 148-153). (Teratogen refers to a substance or process that causes developmental malformations and birth defects.) Both of these studies indicate that there are serious problems related to women either not understanding or not being fully informed about the risks of becoming pregnant while taking Accutane.

The press release went on to say that “Since 1988, the CDC and the Food and Drug Administration (FDA) have worked closely to help educate health care providers and women of reproductive age who may be prescribed Accutane. The devastating birth defects caused by Accutane include: brain defects, heart defects, and facial defects such as babies born without ears.” Women who want to take Accutane are supposed to have two negative pregnancy tests before beginning the medication, use two forms of effective birth control during treatment, and have repeat pregnancy tests every month during the course of medi­cation. It turns out that many women do not follow these recommendations. Moreover, many doctors do not inform their patients that this is required, despite the fact that more women are taking Accutane for their acne than ever before.

In response, the FDA has established new restrictions designed to prevent women from becoming pregnant while they are taking Accutane. According to the FDA, the new require­ments for being allowed to take Accutane, and for a doctor’s ability to prescribe the drug, will include mandatory monthly pregnancy tests. Pharmacists will be allowed to fill only a one-month supply at a time, requiring proof of a negative pregnancy test from the patient. Physicians will have to place an “Accutane Qualification Sticker” on their prescriptions to establish that the patient has had a negative pregnancy test.

You can find more information about the CDC’s work on Accutane and birth defects at www. cdc. gov/ncbddd/bd/accutane. htm. For more information about the FDA’s review of Ac­cutane and birth defects, please see www. fda. gov/cder/drug/infopage/accutane/default. htm.

Updated: September 21, 2015 — 7:14 am