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What's New

November 2008 Safety Labeling Changes - Summary of safety revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides.
(Posted 01/30/2009)

Ethex Corporation Product Recall - Nationwide voluntary recall of multiple products because they may have been manufactured under conditions that did not comply with current Good Manufacturing Practices.
(Posted 01/28/2009)

Venom HYPERDRIVE 3.0 - Product marketed as dietary supplement contains undeclared sibutramine, a controlled substance with risks for abuse or addiction, and can substantially increase blood pressure and heart rate.
(Posted 01/27/2009)

Clopidogrel bisulfate (marketed as Plavix) - FDA to conduct safety review to evaluate differences in efffectiveness, genetic factors, potential drug interactions.
(Posted 01/26/2009)

Topical Anesthetics - Patients, healthcare professionals, and caregivers alerted to serious hazards of using skin numbing products for relieving pain from mammography and other medical tests and conditions, especially when applied to a large area of skin or when the area of application is covered.
(Posted 01/16/2009)

Drug Safety Newsletter, Volume 2, Issue 1, 2009 - FDA newsletter provides information for healthcare professionals about the findings of selected post-marketing drug safety reviews, important emerging drug safety issues, and recently approved new drugs.
(Posted 01/16/2009)

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A self-learning tutorial covering the MedWatch program goals of broadcasting safety information and encouraging adverse event reporting. MedWatch tutorial screenshots
 
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