Major birth defects caused by exposure to Accutane and other brands of isotretinoin, an acne therapy drug, continue to occur in the United States each year because of the failure of voluntary safety measures meant to prevent them, the March of Dimes says.
At an advisory committee meeting to be held tomorrow by the Food & Drug Administration, the March of Dimes will call on the agency to immediately impose tougher restrictions on isotretinoin modeled on the system put in place for thalidomide.
“No pregnant woman should ever take isotretinoin, and no woman taking isotretinoin should ever get pregnant,” says Nancy S. Green, M.D., medical director of the March of Dimes. “However, 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.”
“FDA’s own Center for Drug Evaluation and Research recently concluded that the newest version of voluntary safety measures by manufacturers have produced no substantial improvement in reported pregnancy exposures. The tragic consequence for families has been miscarriages, fetal loss, and major birth defects.
“The March of Dimes urges FDA to mandate a single, stringently monitored and restricted program for isotretinoin, such as the highly effective system created for thalidomide when it was licensed in 1998.”
If such a system is not put into place, the March of Dimes may consider calling for a ban on all systemic forms of isotretinoin, Dr. Green says.
Dr. Green warns women of childbearing age with acne who may want to take isotretinoin to consult a physician qualified to advise on its proper use and avoid Internet suppliers. In addition, she says, those who have prescriptions for isotretinoin should never share this drug with others.
Dr. Green says 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 Accutane. Pregnancy may result in child’s 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’s pregnant,” she says.
Isotretinoin is a member of a family of drugs called retinoids, which are related to vitamin A. Other retinoids include Soriatane (acitretin), Tegison (etretinate), 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.
These precautions have been made to ensure that pregnant women will not reach the drug and will be informed properly of its harmful side effects. Moreover, the program is obviously intended to keep the manufacturer safe from claims, since the number of lawsuits against Roche may increase rapidly after the drug’s adverse reactions disclosure.