The March of Dimes and the Organization of Teratology Information Specialists (OTIS) respectfully request the Food and Drug Administration (FDA) to make public their evaluation of iPledge, the FDA-mandated monitoring program. Under previous voluntary programs, more than 2,000 pregnancies were exposed to isotretinoin.
“Indications are that the number of pregnancies exposed to isotretinoin probably have dramatically decreased, which is what iPledge was designed to do. But we can't be certain without a report about the program's effectiveness,” said Dr. Jennifer Howse, president of March of Dimes. “No pregnant woman should ever take isotretinoin and no woman taking isotretinoin should ever get pregnant.”
Since iPledge began, only a handful of isotretinoin-exposed pregnancies were reported to OTIS. , a formal analysis is underway.
“Between 2001 and 2004, our specialists received about 28 U.S. reports of isotretinoin-exposed pregnancies annually. If iPledge is working, those numbers should decrease dramatically” said Sharon Voyer Lavigne, MS OTIS president.
Internet and overseas sales remain loopholes that must be closed for iPledge to be effective. For two suspected isotretinoin-exposed pregnancies this year, prescriptions were obtained overseas, OTIS said.
Isotretinoin is marketed under several brand names to treat severe acne. It is one of the most potent teratogens (birth defect-causing agent). More than 1.5 million prescriptions were written annually according to 2001-2002 FDA data.
Isotretinoin is chemically related to vitamin A. Birth defects associated with isotretinoin include mental retardation, brain and heart defects. Birth defects or miscarriages can occur soon after conception, often before a woman realizes she is pregnant.
The iPledge program is administered by Covance, a company designated by the drug manufacturers and required to report to the FDA. It was modeled on the strict thalidomide program.
The March of Dimes works to improve the health of babies by preventing birth defects, premature birth and infant mortality. For more information, visit marchofdimes.com or nacersano.org for Spanish language information.
The Organization of Teratology Information Specialists disseminates information about clinical teratology, and provides accurate and timely information about prenatal exposures through a telephone-based service to improve public health. For information, call 866-626-6847.
