Anti-Acne Accutane Can Cause Birth Defects
In 1957, the drug thalidomide was introduced and prescribed to treat morning sickness in pregnant women. Use of the drug resulted in the birth of numerous children with horrendous birth defects in the late 1950’s and early 1960’s. Now, there is concern that another drug could create a new generation of children with abnormalities, and the March of Dimes is calling upon the Food and Drug Administration to employ “the same rigorous system currently used for thalidomide” to govern the use of Accutane.
In September, the Connecticut Chapter of the March of Dimes issued a warning concerning the use of an anti-acne medication and birth defects. At a meeting of the Food and Drug Administration, the March of Dimes urged that the federal agency more closely regulate the use of the drug Accutane because it has been linked to severe birth defects and miscarriage. There is concern that too many pregnant women are being exposed to this medication, and that too many prescriptions are being written for it. Since the month of January has been designated as Birth Defects Month, this is an appropriate time to consider the dangers associated with the use of Accutane, and to inform young women of the risks before they become pregnant while using this drug.
Accutane (the generic name is isotretinion) is a man-made form of Vitamin A that is taken as an oral medication to treat severe, disfiguring acne. It is normally prescribed only after the acne has failed to respond to other treatments. If taken during pregnancy, Accutane can cause birth defects. In women exposed to Accutane during the first trimester of pregnancy, 25-35% of their infants suffered birth defects. Birth defects associated with this drug include microcephaly (small head and brain), hydrocephalus (enlargement of the fluid-filled spaces in the brain), mental retardation, heart defects, cleft lip and palate, ear and eye abnormalities, and occasionally, defects of the thymus gland and limb abnormalities. Some children later demonstrate problems with hand-eye coordination, visual perception, attention span, and organizational abilities. The long-term effects on exposed children are not known.
In addition to the birth defects survivors of Accutane exposure endure, there is a significantly higher rate of miscarriage for pregnant women who have used the drug. Further, a child born with known birth defects may also be at an increased risk for infant death.
A woman who is pregnant and is taking Accutane should stop using the medication immediately and consult her physician to discuss other treatment options and the health risks to her unborn child. Women who are trying to conceive should not use Accutane at all. For women who have used this medication and plan to become pregnant, it could take as long as 10 days after the last dose for the Accutane and its by-products to be eliminated from the body, so at least that much time should be factored in before attempting to become pregnant. If a woman does not plan to become pregnant, she can use Accutane safely if she follows the recommended guidelines for Accutane users who wish to prevent pregnancy. She should discuss this program with her physician.
For further information on the use of Accutane and birth defects, the March of Dimes encourages the use of their toll-free number 1-888-MODIMES; people with access to the Internet can also contact the March of Dimes on line at www.modimes.org. General inquiries also can be directed to the Central Connecticut Health District at 721-2824.