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FDA Warnings on Accutane (New Restrictions)
The FDA has changed its rules regarding the
drug so that doctors must now get patients
to sign a consent form. The form is produced
by Accutane's maker, Roche Pharmaceuticals.
It says the patient understands all the
risks associated with Accutane, including
depression and suicide.
Pharmacists must also hand out a detailed warning brochure
from the FDA, called a Medguide (below).
Accutane is one of just three drugs in the
United States that has ever been required to
come with a Medguide.
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