For Immediate Release August 17, 2001

CDC Media Relations Division
404-639-3286

FDA Office of Communications
Press/Media 301-827-6242

Press Release

Continuing Need to Prevent Exposures During Pregnancy to Medications Known to Cause Birth Defects

The Centers for Disease Control and Prevention (CDC) reported today 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", are published in the September issue of the journal Teratology. A teratogen is a drug or exposure that causes birth defects.

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.

Current recommendations are that women taking Accutane^® who could possibly be or become pregnant should:

• Have two negative pregnancy tests, including one on the 2nd day of their next normal menstrual period, before beginning the medication
• Use two forms of effective birth control
• Have repeat pregnancy tests every month
• Register with the survey that monitors the experience of women on this medication

Many women and prescribers do not follow these recommendations, and over 2,000 pregnancies that were exposed to Accutane^® in the United States have been reported to the FDA from 1982 through March 2000.

"Health care providers must counsel their patients to ensure that these recommendations are followed to prevent these serious and completely preventable birth defects," said José Cordero, M.D., MPH, acting director of CDC’s National Center on Birth Defects and Developmental Disabilities.

The teratogen warning symbol shows a pregnant woman in a circle with a slash through it. While the symbol can serve as an effective reminder of educational counseling given to patients, the study found that many women who saw the symbol without counseling were unable to say what the warning symbol meant. It also found that one third of study participants confused the medication with birth control. The researchers caution that drug manufacturers and marketers need to make sure that drug package text and symbols are clear and cannot increase risks to consumers. Health professionals who prescribe drugs that cause birth defects should make sure that their patients fully understand the potential for harm.

FDA and the manufacturer of Accutane^®, Hoffman-LaRoche, are finalizing a substantially enhanced risk management program for Accutane^®. Efforts to strengthen the existing Pregnancy Prevention Program (PPP) were endorsed in September 2000 at a public advisory committee meeting.

"The two studies appearing in Teratology demonstrate the compelling need for an even stronger risk management program for this drug. Such a program must involve the drug manufacturers, pharmacists and patients. Clearly, more needs to be done soon to communicate and manage these risks," said Steven Galson, M.D., MPH, Deputy Director of FDA's Center for Drug Evaluation and Research.

For more information about CDC’s work on Accutane^® and birth defects, please see our website at: http://www.cdc.gov/ncbddd/bd/accutane.htm.

For more information about the FDA’s review of Accutane^® and birth defects, please see http://www.fda.gov/cder/drug/infopage/accutane/default.htm.

The Centers for Disease Control and Prevention (CDC) protects people's health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong partnerships with local, national and international organizations.

FDA, the nation's foremost consumer protection agency, oversees the safety and in most cases the quality and effectiveness of a trillion dollars' worth of products that constitute nearly one-fourth of the total consumer expenditures of U.S. citizens. These goods include all food except for meat and poultry; all prescription and non-prescription drugs; all blood products, vaccines, and tissues for transplantation; all medical equipment and all devices that emit radiation, including microwave ovens; all animal drugs and feed; and even all cosmetics.

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