SALT LAKE CITY, April 26 /PRNewswire/ -- Pregnancy and powerful acne
medicines like Accutane(R) don't mix. That's the message pregnancy counselors
with the Organization of Teratology Information Services (OTIS) are trying to
convey to pregnant women, health care providers, pharmaceutical companies, and
decision-makers in the federal government.
Women who have used Accutane(R), known generically as isotretinoin, within
30 days of becoming pregnant are encouraged to participate in an ongoing OTIS
study by calling the North American Isotretinoin information and Survey Line
(866-626-6847).
Callers will be given information on the potential effects of isotretinoin
and be asked to take a brief survey about how much isotretinoin they were
using when they became pregnant, how they obtained the drug, and what level of
education they received when the drug was prescribed.
"Having nice-looking skin is not worth the risk of having an abnormal baby
or child," stressed Debbie Banner, a Virginia mother whose son was born with
brain damage as a result of Accutane(R) exposure during her pregnancy.
The FDA approved Accutane(R) in 1982 as a prescription medication for
severe or cystic acne. Although the drug's label warned it was not to be
taken by pregnant women, exposed pregnancies continued. It was found that
Accutane(R) was a teratogen, meaning it can cause brain and heart defects,
mental retardation, and other abnormalities.
By 1999, it was reported that nearly three out of every 1,000 American
women aged 15-44 were taking Accutane(R). The more recent introduction of
additional forms of isotretinoin (Amnesteem(R), Claravis(R), and Sotret(R))
may further increase usage.
In late February, the Food and Drug Administration (FDA) held hearings to
consider imposing stricter regulations on Accutane(R), which has been shown to
cause birth and developmental defects.
OTIS, a nonprofit organization that conducts research and provides
education on the effects of drugs and chemicals on the human fetus, presented
preliminary findings from a survey of women in the U.S. and Canada who used
Accutane(R) at the time they became pregnant. OTIS told FDA members that only
the most stringent restrictions could prevent more Accutane-exposed
pregnancies.
The FDA has agreed to review recommendations by an advisory panel for
manufacturers to establish a national registry system in which all patients
using any form of isotretinoin would be required to enroll. For female
patients, this would mean they could no longer obtain a prescription without a
negative pregnancy test and written instructions by their doctor to use two
forms of birth control while on the drug.
"We encourage the manufacturers of isotretinoin to implement a mandatory,
nationwide registry, including required contraception counseling by trained
professionals," said Dr. John C. Carey of the University of Utah School of
Medicine and Medical Director of Utah's Pregnancy Risk Line, which was
instrumental in obtaining the grant for the OTIS survey.
The grant awarded by the Centers For Disease Control and Prevention has
enabled OTIS and more than 20 other teratology information organizations
across North America to gather critical data about exposure to Accutane(R) and
generic isotretinoin during pregnancy. The hope is the findings will be used
in future decisions about drug regulation as well as to increase and expand
pregnancy prevention education.
To enroll in the survey, or find out more about birth defects caused by
isotretinoin, call toll-free 1-866-626-OTIS (6847) or go to the OTIS web site
at http://www.otispregnancy.org.
SOURCE Organization of Teratology Information Services
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Related links:
http://www.otispregnancy.org
CONTACT:
Julia Robertson, +1-800-687-7597, or Marcie
McCleary, +1-801-485-4449, both for Organization of Teratology
Information Services
NOTE TO EDITORS: For more information or interviews, contact:
Julia Robertson, 800-687-7597, or Marcie McCleary, 801-485-4449.
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