Home > FDA MedWatch > FDA MedWatch – February 2011 Safety Labeling Changes

FDA MedWatch – February 2011 Safety Labeling Changes

The MedWatch February 2011 Safety Labeling Changes posting includes 53 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/ucm242998.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:

Avandia (rosiglitazone maleate) Avandamet (rosiglitazone maleate/metformin hydrochloride) and Avandaryl (rosiglitazone maleate/glimepiride) Tablets
Avelox (moxifloxacin hydrochloride) tablets and Avelox (moxifloxacin hydrochloride in NaCl injection) I.V.
Cipro (ciprofloxacin hydrochloride) Tablets, Oral Suspension, IV and Cipro XR (ciprofloxacin extended-release tablets)
Factive (gemifloxacin mesylate) Tablets
Floxin (ofloxacin) Tablets
Heparin Sodium Injection, USP
Humatrope (somatropin [rDNA origin]) for injection
Increlex (mecasermin [rDNA origin] injection
Kaletra (lopinavir/ritonavir) Tablets and Oral Solution
Levaquin (levofloxacin) Tablets, Oral Solution and Injection
Multaq (dronedarone hydrochloride) Tablets
Noroxin (norfloxacin) Tablets
Prilosec OTC (omeprazole magnesium) delayed-release tablets
Promacta (eltrombopag) Tablets
Proquin XR (ciprofloxacin) Extended-Release Tablets
Remicade (Infliximab)
Tekturna (aliskiren) and Tekturna HCT (aliskiren/hydrochlorothiazide) Tablets
Toviaz (fesoterodine fumarate) Extended Release Tablets
Valturna (aliskiren/valsartan) Tablets
Zebeta (bisoprolol fumarate) Tablets

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