NEW YORK, Jan 20 (Reuters Health) -- Despite a decade of public warnings,
experts at the US Centers for Disease Control and Prevention (CDC) say birth
defects linked to use of the prescription acne medication Accutane continue to
occur.
"Physicians should limit use of the drug in women of childbearing age,"
according to a report published in the January 21st issue of the CDC's journal
Morbidity and Mortality Weekly Report.
Accutane (isotretinoin) has been approved by the US Food and Drug
Administration (FDA) for patients with severe, disfiguring acne that do not
respond to other forms of treatment. After birth defects linked to use of the
drug began to surface in the 1980s, the drug's manufacturer, Roche Laboratories
of Nutley, New Jersey, began in 1988 to inform physicians and patients about the
potential dangers of severe birth defects when the drug is used by women of
childbearing age. Drug packaging also includes labeling clearly warning women of
the potential dangers involved in using Accutane.
To determine whether these education efforts have succeeded in reducing or
eliminating birth defects linked to Accutane use, the CDC examined the cases of
14 women who had recently taken the drug during their pregnancies.
According to the authors, "four live-born infants with no major
malformations... (and) one live-born infant (with) major malformations" resulted
from these 14 pregnancies. The other 9 pregnancies ended in either miscarriage
or abortion.
The 25-year-old woman who delivered the one malformed infant began taking
Accutane after an initial pregnancy test was negative. "She had been using two
forms of contraception" during her course of medication, as recommended, the CDC
researchers add, "but did not wait for menstruation before starting isotretinoin
therapy as recommended." Her infant died at 9 weeks of age after being born with
severe defects of the heart, brain, and face.
The CDC authors believe that despite widespread warnings to the contrary,
too many dermatologists are prescribing Accutane to women who fall outside the
recommended patient population. In fact, at least half of the 14 women studied
said they did not have the "severe, disfiguring nodular acne" the drug is
targeted to treat. For example, one patient -- who ended her pregnancy due to
fears about the drug -- had obtained the drug to prevent menstruation-related
monthly acne outbreaks.
The authors also warn that many patients are obtaining the drug from
sources other than their doctors, or from other countries such as Mexico.
Based on the findings, the CDC experts recommend that doctors take special
care to fully inform appropriate female patients of the risks and precautions
associated with Accutane use.
