WHITE PLAINS, N.Y., AUGUST 12, 2005 – The following statement was issued today by Nancy S. Green, M.D., medical director of the March of Dimes, in response to a strengthened risk management program for Accutane and other brands of isotretinoin called iPLEDGE announced today by the U.S. Food and Drug Administration (FDA).
"The March of Dimes has been working for two decades to improve the inadequate voluntary programs for regulation of isotretinoin. No pregnant woman should ever take isotretinoin, and no woman taking isotretinoin should get pregnant. The voluntary safety measures created by manufacturers failed to provide adequate safety measures, which sadly meant that many pregnancies were exposed to this potent birth defects-causing agent. The tragic consequences for families have been miscarriages, fetal losses, and major birth defects. There have been at least 2,000 exposed pregnancies reported since this drug was introduced, and this figure may be only the tip of the iceberg.
"We applaud FDA's strengthened risk management program for isotretinoin, making it a single, mandatory program. We expect that the agency will collect data on exposures from the manufacturers and make this information available to the public in a timely fashion so that we and other concerned entities can see if there are gaps in the program that could be addressed. We are still concerned about the multiple generic forms of this drug, which can be confusing to patients and hinder compliance with the regulations -- so we will have to see how this unfolds.
"Women of childbearing age with acne who may want to take isotretinoin should consult a physician qualified to advise on its proper use and must avoid Internet suppliers. We've seen no statement from FDA about regulating Internet sales, so we remain deeply worried about this loophole."
There is a high risk of fetal malformations if a woman becomes pregnant while taking isotretinoin, even if she is taking a small amount of the drug for a short period. Birth defects associated with isotretinoin include hydrocephaly (enlargement of the fluid-filled spaces in the brain); microcephaly (small head and brain); mental retardation; heart defects; ear and eye abnormalities; cleft lip and palate; and other facial abnormalities.
Isotretinoin can cause these birth defects in the early weeks after conception, a time when a woman often doesn't know she is pregnant.
Isotretinoin is a member of a family of drugs called retinoids, which are related to vitamin A. Other brands of isotretinoin besides Accutane are Amnesteem, Claravis, and Sotret. Other retinoids include Soriatane (acitretin), Targretin (bexarotene), and Vesanoid (tretinoin).
In a January 2000 issue of Morbidity and Mortality Weekly Report, the Boston University Accutane Survey (BUAS) reported that 900 women became pregnant while taking isotretinoin between 1989 and 1999, a rate of 3 women becoming pregnant for each 1000 treatments with the drug. Roche Laboratories, makers of Accutane, reported to FDA that, from 1982 to 2000, there were 1,995 pregnancy exposures and 383 live births, of which 162 had birth defects. FDA says there were 325 known pregnancies in users of isotretinoin between April 1, 2001 and August 15, 2003.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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