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New Accutane Requirements
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 information, visit www.ipledgeprogram.com or telephone
1-866-495-0654.
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