Health News

Birth Defects Still Happening With Accutane

By Alison Palkhivala
WebMD Medical News
Reviewed by Jacqueline Brooks, MRCPsych, MBBCH
Aug. 17, 2001 -- Women still aren't getting the message that taking the
acne-fighting prescription drug Accutane while pregnant vastly
increases the chances an unborn child will have a birth defect. New
research suggests that one explanation might be that warning symbols
on the package aren't clear.

Accutane, also known as isotretinoin, is known to cause birth defects,

including brain, heart, and face deformities, if women take it while
pregnant. Because of this, it is recommended that women of
childbearing age taking the drug be tested for pregnancy before
starting it and then repeatedly during their treatment. They should also
use two forms of birth control while on the medication.

The manufacturer, drug company Hoffman-LaRoche, started placing

warnings about this risk all over Accutane packages in 1988 and even
started advertising about these risks in 1996. This effort does not
appear to be enough, however, according to two new studies.

In the first study, Margaret A. Honein, PhD, MPH, and colleagues

studied how many women of childbearing age take Accutane. They
found that prescriptions for this drug to this group have more than
doubled in the past 10 years, resulting in 2.5 of every 1,000 women of
childbearing age taking the drug in the U.S. in 1999.

Interviews with 14 women who took Accutane while pregnant revealed

that only one had used the recommended two forms of birth control
while taking the drug, and eight hadn't used any birth control at all.

Further, none of them saw all of the information on the package about
the risks of taking Accutane during pregnancy, and only four saw the
information printed directly on the pill packet.

"Accutane-exposed pregnancies continue to occur and result in babies

with major birth defects," Honein tells WebMD. "Women and their
physicians need to ensure that effective methods of contraception are
used to avoid exposed pregnancies." Honein is an epidemiologist from
the National Center on Birth Defects and Developmental Disabilities at
the CDC in Atlanta.

In the second study, Katherine Lyon-Daniel, PhD, and colleagues

interviewed 97 women of childbearing age about symbols used on
some medication packages that are meant to denote that a drug can
cause birth defects. The symbol depicts a pregnant woman with a bar
across the image, like in a no smoking sign, and includes the words ''do
not get pregnant.''

Only about a fifth of women correctly interpreted the symbol to mean

that they should not take the medication while pregnant or not get
pregnant while taking the medication. Others interpreted it to mean
that the package contained birth control medication or simply that the
package contained drugs or medicine.

Both studies are published in the August 2001 issue of the medical
journal Teratology.

"Most concerning was that about a third of study participants thought

that the symbol indicated the drug was a contraceptive, which might
decrease their efforts to use other methods of birth control", says Lyon-
Daniel, who is a behavioral scientist from the CDC's Birth Defects and
Pediatric Genetics branch of the National Center on Birth Defects and
Developmental Disabilities.

"We can't take for granted that just because a symbol has been put on
a drug that everyone interprets the symbol in the same way," says
Jonca Bull, MD. "Contraception and absolute vigilance is so critical with
a drug [like Accutane] that has such a high risk of [producing birth
defects]. The drug is commonly used by individuals in their peak
reproductive years. As we all know, acne is basically a disease of
young people."

Bull is acting director and deputy office director for the office of drug
evaluation at the Center for Drug Evaluation and Research of the FDA
in Rockville, MD.

Hoffman-LaRoche, in collaboration with the FDA, is currently

developing a stepped-up program to improve public awareness of the
risks of taking Accutane while pregnant.