Urges FDA to Monitor Internet Purchases of Accutane to Prevent Birth Defects
WHITE PLAINS, N.Y., FEBRUARY 9, 2006 – Starting March 1, all patients prescribed Accutane or other isotretinoin drugs must register with a new federal monitoring program designed to prevent birth defects or the prescription will not be filled.
The March of Dimes applauds the new U.S. Food & Drug Administration iPledge program and urges the agency to monitor its effectiveness and to create comparable programs for other oral retinoid medications.
The organization's comments came in a national policy statement on retinoid drugs such as Accutane and the psoriasis medication Soriatane (acitretin).
"While the March of Dimes is cautiously optimistic iPledge will be successful in preventing pregnancy exposures, we remain concerned some patients may seek to purchase isotretinoin via the Internet and circumvent the requirements," says Nancy S. Green, M.D., March of Dimes medical director. "Even with iPledge, women may still obtain the drug from friends or other sources without knowing its powerful potential to cause birth defects."
Despite a previous voluntary monitoring program, more than 1,000 women using Accutane became pregnant since the drug was first licensed, and babies were born with birth defects caused by the drug. Isotretinoin is one of the most potent known teratogens (birth defect causing agent) available.
"No pregnant woman should ever take isotretinoin and no woman taking isotretinoin should ever get pregnant," said Dr. Green. "We applaud the FDA's requirements and expect officials to carefully monitor this program. Oral retinoid drugs are extremely hazardous, even fatal, to the developing fetus. Thorough monitoring and education is needed to ensure no infant ever again develops a birth defect because of these drugs."
Retinoids are chemically related to vitamin A, which plays a role in embryonic and fetal development. Birth defects associated with isotretinoin include hydrocephaly (enlargement of the brain's fluid-filled spaces); microcephaly (small head and brain); mental retardation; heart defects; ear and eye abnormalities; cleft lip and palate; and others. Isotretinoin can cause birth defects in the early weeks after conception, before a woman realizes she is pregnant.
Federal regulations requiring wholesale and retail providers of isotretinoin drugs to register with iPledge went into effect December 30. Women with childbearing potential must take two pregnancy tests with laboratory-confirmed negative results before obtaining a prescription and must take monthly pregnancy tests.
Other brands of isotretinoin include Amnesteem, Claravis and Sotret. Other retinoids include Targretin and Vesanoid.
The March of Dimes is a national voluntary health agency whose mission is to improve the health of babies by preventing birth defects, premature birth, and infant mortality. Founded in 1938, the March of Dimes funds programs of research, community services, education, and advocacy to save babies and in 2003 launched a campaign to address the increasing rate of premature birth. For more information, visit the March of Dimes Web site at marchofdimes.com or its Spanish language Web site at nacersano.org.
Contact
Todd P. Dezen, (914) 997-4608, tdezen@marchofdimes.com
Elizabeth Lynch, (914) 997-4286, elynch@marchofdimes.com
Robert Storace, (914) 997-4622, rstorace@marchofdimes.com
