Accutanes Pregnancy Risk: Are Women Aware?

Oct. 14, 2005 -- Some women apparently aren't getting the message that they shouldn't take the acne drug Accutane and its generic versions during pregnancy.

Accutane and its generic versions are an effective acne treatment, but they're not intended for use during pregnancy due to the risk of birth defects.

That well-publicized risk is stressed in information from the drug's makers. The FDA also recently tightened its rulesThe FDA also recently tightened its rules to try to prevent pregnant women from taking Accutane or its generic versions.

The drug's old pregnancy prevention program was voluntary. It wasn't always heeded, a new report shows.

The researchers included Julia Robertson of the Birth Defects and Genetics Program in Utah's health department. Their findings appear online in Birth Defects Research (Part A): Clinical and Molecular Teratology.

Pregnant and at Risk

The report included 34 women who had taken Accutane or its generic versions while pregnant. Between April 2002 and September 2004, the women had voluntarily called a hotline run by the Organization of Teratology Information Services.

A teratogen is a substance that causes birth defects.

Many of the women said they didn't remember hearing or following the old guidelines.

For instance, the old program recommended that women get birth control counseling and two negative pregnancy tests before starting the drug.

Eight women said they didn't remember being counseled about birth control, and 25 said they hadn't gotten a second pregnancy test before taking the drug.

Also, the program advised monthly pregnancy tests while women took the drug. More than half said they hadn't done that. The drug is usually taken for four to six months.

In addition, few women reported having the type of severe acne for which the drug is intended.

It's possible that the women's reports weren't accurate. There's also no information on women for whom the old program worked since they didn't have a reason to call the birth defects hotline.

New Rules

The new program, announced by the FDA in August, is called "iPLEDGE."

The iPLEDGE plan requires virtually everyone involved with prescribing, supplying, or using the drug to register and accept certain responsibilities.

For women of childbearing age, those responsibilities include:

• Signing an informed consent form in their doctor's office.
• Personally registering with iPLEDGE.
• Getting two negative pregnancy tests within seven days of starting the drug.
• Agreeing to use two forms of birth control.
• Getting a negative pregnancy test within seven days of seeking their monthly drug refill.

The pregnancy tests must be done in a doctor's office or at a lab. Home pregnancy tests do not count.

Men also have to sign an informed consent form and be registered through their doctor's office, but they don't need to personally sign up with iPLEDGE or follow the plan's pregnancy-related rules.

Doctors, Pharmacies Also Involved

Doctors, pharmacies, and wholesalers must also register with iPLEDGE and take on certain duties.

For instance, the prescribing doctor must counsel patients about the drug's risks, give them an informed consent form, register with iPLEDGE, note patients taking the drug in the iPLEDGE system, and receive patients' pregnancy test results.

Pharmacies must log on to iPLEDGE and check that everything is in order before filling a prescription for the drug for women of childbearing age.

Wholesale companies must agree only to give the drug to pharmacies that register with iPLEDGE.

For more information or to register for iPLEDGE, go to www.ipledgeprogram.com or call (866) 495-0654.

SOURCES: Robertson, J. Birth Defects Research (Part A): Clinical and Molecular Teratology, Oct. 14, 2005; online edition. WebMD Medical News: "FDA OKs Tighter Controls for Accutane.""FDA OKs Tighter Controls for Accutane." News release, John Wiley & Sons, Inc.