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Accutane iPLEDGE Program Glitches Continue Six Months After Launch – AADA

Executive Summary

Implementation problems with the iPLEDGE pregnancy risk management program for the acne therapy isotretinoin (Roche's Accutane and generics) may be relieved by eliminating the mandatory one month hiatus between physician office visits, a study by the American Academy of Dermatology Association found

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FDA warns against purchasing Accutane online

FDA launches a Web site March 28 to warn consumers about the dangers of purchasing the acne medication isotretinoin (Roche's Accutane and generics) online. The agency advises, "Buying this product over the Internet bypasses important procedures to ensure that patients can take this drug safely," and may result in patients receiving counterfeit products. Isotretinoin is legally available only through iPLEDGE, a restricted distribution and risk management system to ensure the drug is not prescribed to pregnant patients. However, implementation of the iPLEDGE program has been plagued with compliance issues (1"The Pink Sheet" Sept. 4, 2006, p.15)...

FDA warns against purchasing Accutane online

FDA launches a Web site March 28 to warn consumers about the dangers of purchasing the acne medication isotretinoin (Roche's Accutane and generics) online. The agency advises, "Buying this product over the Internet bypasses important procedures to ensure that patients can take this drug safely," and may result in patients receiving counterfeit products. Isotretinoin is legally available only through iPLEDGE, a restricted distribution and risk management system to ensure the drug is not prescribed to pregnant patients. However, implementation of the iPLEDGE program has been plagued with compliance issues (1"The Pink Sheet" Sept. 4, 2006, p.15)...

Accutane iPLEDGE Program Tops CDER Ombudsman’s 2006 Complaint List

The most frequent complaint to the Center for Drug Evaluation & Research Ombudsman's office in 2006 concerned implementation of the iPLEDGE program, the office said in its annual report, issued Feb. 28

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