FDA Puts New Restrictions on Accutane
Accutane is the most effective drug we have to treat acne, but also the most controversial. The media has been irresponsible at times by reporting stories of questionable side effects and in effect demonizing this very safe and useful drug. However, the one side effect that is not in any way questionable is that Accutane can cause birth defects and therefore cannot be given to a woman who may become pregnant.
New Restrictions:
In an effort to eliminate Accutane-related birth defects, the thousands of Americans who take the acne drug Accutane — and people who prescribe and dispense it — must now enroll in a national registry.
Under the program, every patient — men and women — must enroll in the iPLEDGE computerized registry starting Dec. 31 2006 to receive Accutane or generic versions of the drug isotretinoin. Doctors must register, too, if they wish to continue prescribing the pills. Drugstores and wholesalers also must register in order for the pills’ manufacturers to ship them any supplies.
Additional Step for Women:
Women must undergo two tests to...
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