Accutane's Pregnancy Risk: Are Women Aware?
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
That well-publicized risk is stressed in information from the drug's
makers. The FDA also recently tightened its rules to try to prevent
pregnant women from taking acne drugs such as Accutane or its generic
The drug's old pregnancy prevention program was voluntary. It wasn't always heeded, a new report shows.
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
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
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 acne drugs.
Also, the program advised monthly pregnancy tests while women took
the Accutane or similar acne drug. More than half said they hadn't done
Acne drugs are usually taken for four to six months.
In addition, few women reported having the type of severe acne for which the drug is intended.
The new program, announced by the FDA, is called "iPLEDGE." The
iPLEDGE plan requires virtually everyone involved with prescribing,
supplying, or using acne drug Accutane or its generic versions to
register and accept certain responsibilities such as getting two
negative pregnancy tests within seven days of starting Accutane and
agreeing to use two forms of birth control.