 Registration Reqired For Accutane
by: Ron King
If you have severe acne that requires Accutane (isotretinoin), you will be unable to get it after December 31, 2005 unless you are enrolled in the FDA’s new iPLEDGE program by a physician who is also enrolled.
In an effort to reduce the number of birth defects caused by isotretinoin, these new rules require anyone involved in the use or distribution of Accutane to be registered in iPLEDGE and to abide by certain reporting requirements.
Specifically, users of Accutane (or any other drug containing isotretinoin) must do the following:
For everyone:
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You must be registered in iPLEDGE by your doctor, who must also be registered.
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You must understand the severe birth defects that can occur with use of isotretinoin by a female who could become pregnant.
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You must receive and read educational materials with safety information about isotretinoin and about iPLEDGE program requirements.
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You must sign an Informed Consent form that contains warnings about the risks of isotretinoin.
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You must fill your prescription for isotretinoin within 7 days of your doctor visit.
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You must agree to see your doctor every month during treatment for a progress check-up and to get a new prescription for isotretinoin.
For women of childbearing age, in addition:
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You must not be pregnant or breast-feeding.
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You must have 2 negative pregnancy tests before starting isotretinoin, a negative pregnancy test every month during treatment, and a negative pregnancy test one month after treatment has ended.
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You must use 2 different forms of birth control at all times unless you agree not to have heterosexual intercourse for 1 month before isotretinoin treatment, during treatment, and for 1 month after treatment has ended.
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You must sign a second Informed Consent form with warnings about the risks of birth defects if pregnancy occurs before or during isotretinoin treatment.
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You must access the iPLEDGE program on the Internet or by telephone before starting isotretinoin, once a month during treatment, and 1 month after ending treatment to answer questions about program requirements and to enter the 2 forms of birth control you have chosen.
To begin or to continue using Accutane after December 31, 2005, you must be sure that you and your doctor are registered with the iPLEDGE program. The above is not a complete listing of program requirements.
For more information, you see www.ipledgeprogram.com or telephone 1-866-495-0654.
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