September 2009 Drug Safety Labeling Changes - 36 drugs with changes*

The "Summary Page" provides a listing of drug names and safety labeling sections revised.

Nov 2, 2009

Clicking on a drug product name in the Summary View will take you to the "detailed view" page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.

The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:

AndroGel (testosterone gel), Rapamune (sirolimus), Testim (testosterone gel), Cordarone (amiodarone HCl), Flector Patch (diclofenac epolamine), Intelence (etravirine), Kayexalate (sodium polystyrene sulfonate), Lexiva (fosamprenavir calcium), Neoral (cyclosporine capsules, modified), Ortho Evra (norelgestromin/ethinyl estradiol) transdermal system, Pre-Pen (benzylpenicilloyl polylysine), Sustiva (efavirenz), Ultracet (tramadol HCl/acetaminophen), Ultram (tramadol hydrochloride), Voltaren Gel (diclofenac sodium), Zolinza (vorinostat).

FDA

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