FDA notified consumers and healthcare professionals of
a special webpage launched to warn about the dangers of buying
isotretinoin online. Isotretinoin is a drug approved for the treatment of
severe acne that does not respond to other forms of treatment. If the drug
is improperly used, it can cause severe side effects, including birth
defects. Serious mental health problems have also been reported with
isotretinoin use.
The new webpage, http://www.fda.gov/buyonline/accutane, will appear in
online search results for Accutane (isotretinoin) or one of the generic
versions, Amnesteem, Claravis, and Sotret. The webpage warns that the drug
should only be taken under the close supervision of a physician or a
pharmacist, and provides links to helpful information. The new webpage is
in addition to special safeguards put in place by FDA and manufacturers of
isotretinoin to reduce the risks of the drug, including a risk management
program called iPLEDGE. The aim of iPLEDGE is to ensure that women using
isotretinoin do not become pregnant, and that women who are pregnant do
not use isotretinoin.
