Starting January 1, 2006 people with severe acne who need Accutane (isotretinoin), must enroll in the FDA’s new iPLEDGE program through 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 its reporting requirements.
Specifically, users of Accutane (or any other drug containing isotretinoin) must do the following:
Everyone:
- must be registered in iPLEDGE by your doctor, who must also be registered.
- must understand that severe birth defects can occur with use of isotretinoin by a female who could become pregnant.
- must receive and read educational materials with safety information about isotretinoin and about iPLEDGE program requirements.
- must sign an Informed Consent form that contains warnings about the risks of isotretinoin.
- must fill your prescription for isotretinoin within 7 days of your doctor visit.
- must agree to see your doctor every month during treatment for a progress check-up and to get a new prescription for isotretinoin.
Women of childbearing age, in addition:
- must not be pregnant or breast-feeding.
- must have 2 negative pregnancy tests before starting isotretinoin, a negative pregnancy test every month during treatment, and a negative pregnancy test 1 month after treatment has ended.
- 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.
- must sign a second Informed Consent form with warnings about the risks of birth defects if pregnancy occurs before or during isotretinoin treatment.
- 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.
The above is not a complete listing of program requirements.
For more IPLEDGE info, visit www.ipledgeprogram.com or telephone 1-866-495-0654.
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