Home > FDA MedWatch > FDA MedWatch – April 2011 Drug Safety Labeling Changes

FDA MedWatch – April 2011 Drug Safety Labeling Changes

The MedWatch April 2011 Safety Labeling Changes posting includes 43 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

The “Summary Page” provides a listing of drug names and safety labeling sections revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm253470.htm

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.

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

Aplenzin (bupropion hydrobromide) Extended-Release Tablets
Fosrenal (lanthanum carbonate) Chewable Tablets
Advil (ibuprofen) Infants oral suspension
Advil (ibuprofen) tablets
Advil Liqui-Gels (ibuprofen) capsules
Advil PM (ibuprofen 200 mg/diphenhydramine citrate 38 mg) tablets
Aleve (naproxen sodium) tablets
Chorionic Gonadotropin for Injection
Combivent (ipratropium bromide and albuterol sulfate) Aerosol
Cyanokit (hydroxocobalamin for Injection)
Demerol (meperidine hydrochloride)
Eligard (leuprolide acetate) injectable suspension
Fuzeon (enfuvirtide) for Injection
Gleevec (imatinib mesylate) Tablets
Invega (paliperidone) extended-release tablets
Janumet (sitagliptin/metformin hydrochloride) Tablets
Januvia (sitagliptin) Tablets
Lysteda (tranexamic acid) Tablets
Novarel (chorionic gonadotropin for Injection, USP)
Omnitrope (somatropin [rDNA origin] injection)
Pregnyl (chorionic gonadotropin for Injection, USP)
Zemplar (Paricalcitol) Injection

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