New FDA Web Page Warns Against Buying Isotretinoin Products Online

Yael Waknine


March 29, 2007

March 29, 2007 — The US Food and Drug Administration (FDA) recently launched a new Web site to warn consumers of the dangers associated with buying isotretinoin online, the agency announced today.

The Web page, , will appear in online search results for isotretinoin ( Accutane, Hoffman La-Roche) and its generic versions, Amnesteem (Genpharm, Inc), Claravis (Barr Pharmaceuticals, Inc), and Sotret (Ranbaxy Pharmaceuticals, Inc), according to an alert from MedWatch, the FDA's safety information and adverse event reporting program.

The FDA Web page warns that isotretinoin should only be taken under the close supervision of a physician or pharmacist because of the risks for birth defects, miscarriage, premature birth, and neonatal death. Spontaneous psychiatric disturbances have also been reported, including depression and suicide.

Other risks include severe headaches, blurred vision, dizziness, nausea, vomiting, seizures, stroke, diarrhea, and muscle weakness.

The new page also provides links regarding the safe use of these products

The FDA notes that purchase of isotretinoin without a prescription precludes the implementation of safeguards such as iPledge, the risk management program intended to reduce the risk for fetal exposure to the teratogenic drug. Under the program, women of child-bearing age must undergo monthly pregnancy testing to ensure that they have not conceived during treatment.

Furthermore, Web sites that offer prescription drugs without the required prescription may provide products that are counterfeit, have dangerous ingredients, are inactive, or are not labeled or shipped correctly, according to the FDA. In addition to being dangerous, such purchases are illegal.

Isotretinoin is indicated for the treatment of severe recalcitrant nodular acne.

Adverse events potentially related to use of isotretinoin should be reported to the manufacturer and to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at , or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.


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