Tag Archives: Incivek

Incivek telaprevir Drug Safety Communication

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Translation Incivek (telaprevir) In Combination with Drugs Peginterferon Alfa and Ribavirin (Incivek Combination Treatment): Drug Safety Communication – Serious Skin Reactions   AUDIENCE: Internal Medicine, Gastroenterology, Dermatology ISSUE: FDA received reports of serious skin reactions, some fatal, in patients taking … Continue reading

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Posted in Dermatology, FDA Label Change, FDA Safety Communication, Gastroenterology, Internal Medicine | Tagged , , , , , , , , , | Comments Off

June 2012 Safety Labeling Changes

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TranslationThe MedWatch June 2012 Safety Labeling Changes posting includes 35 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The “Summary Page” provides a listing of drug names and … Continue reading

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Posted in FDA 2012, FDA Label Change, FDA Safety Communication | Tagged , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , | Comments Off