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drug_recall accutaneFirst hitting the market in 1982, Accutane birth defects have been occurring at a much too high rate for too long, according to critics. A prescription acne medication, Accutane is prescribed to over 1 million patients every year, eventhough Accutane is intended for use as a last resort in severe cases of acne. Considering the arguably potentially deadly effects the use of Accutane can lead to, many who oppose Accutane’s wide availability feel that the drug is being prescribed far too often to patients with only mild or moderate cases of acne.
There are more than 2,000 reports of women becoming pregnant while using Accutane, despite its links to severe fetal brain and heart defects, mental retardation, and other birth abnormalities. Estimates show that Accutane may be prescribed to 26 times more women than it should be. Most of the women that have become pregnant while using Accutane have opted for abortion rather than risk Accutane birth defects.
Although there have been some instances of healthy pregnancies, the drug agency has counted over 160 Accutane birth defects. Many believe the number of Accutane birth defects counted by the FDA is extremely low, especially considering doctors are not required to report Accutane linked pregnancies. At a recent FDA advisory committee meeting, Public Citizen director described Accutane birth defects, saying about 25 percent of babies born to mothers taking Accutane have serious birth defects and 50 percent are mentally disabled.
Despite the warnings to doctors and patients of the risks of Accutane birth defects, the occurrence of pregnancies remained. The agency was criticized for failing to more strictly enforce a program to reduce the potential Accutane birth defects. In 2001, the FDA''s own advisory committee recommended the agency put a registry in place to curb the number of Accutane birth defects. The FDA and Accutane''s manufacturer Roche launched the program in April 2002.
The first year the registry was put into place, of the 61 reported pregnancies, 48 ended in elective abortions due to concerns of the high rate of Accutane birth defects. In the time between 1982 and 2000 there were 162 babies reported to have Accutane birth defects. At the February 2004 FDA advisory committee meeting, Public Citizen''s director Sidney Wolfe stated, "if the government doesn''t act, this administration and advisory committee will continue to put its imprimatur on the reckless use of a drug that each year causes the need for hundreds of abortions and results in many seriously deformed infants with birth defects."
For years, the government has known about Accutane birth defects but has failed to implement adequate measures to reduce these numbers. In 1983, Public Citizen first petitioned the FDA to give patients warning information with Accutane and petitioned for an Accutane ban in 1998. In 2004, the FDA began debating guidelines because of the Accutane birth defects. Talks of a registry system mandating women not being able to get their monthly supply of Accutane without a negative pregnancy test, and proof of using two forms of contraception, every health worker prescribing Accutane, as well as every drugstore dispensing it, must also be registered. When the women go to the drugstore to get the Accutane, the store must double check to make sure the women are properly cleared.
These Accutane birth defects measures are too little, too late, according to angry family members and consumer groups. Accutane birth defects risks exist even when using the acne medication for a short period of time in small doses. They can even remain a risk for 30 days after discontinuing the use of the drug.
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