The MedWatch June 2011 Safety Labeling Changes posting includes 50 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/ucm261325.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:
Avalide (irbesartan/hydrochlorothiazide) tablets
Avodart (dutasteride) soft gelatin capsules
Corgard (nadolol) tablets
Corzide (nadolol and bendroflumethiazide) tablets
Diflucan (fluconazole) tablets, I.V, and oral suspension
Diovan (valsartan) tablets
Ditropan XL (oxybutynin chloride) tablets
Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) tablets
Feraheme (ferumoxytol) injection
Fioricet with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) Capsules
Jalyn (dutasteride and tamsulosin) capsules
Kenalog-10 (triamcinolone acetonide) injection and Kenalog-40 (triamcinolone acetonide) injection
Nexium (esomeprazole magnesium) for delayed-release oral suspension, delayed-release capsules and (esomeprazole sodium) for injection
Photofrin (porfimer sodium) for injection
Prilosec (omeprazole magnesium) for delayed-release oral suspension and delayed-release capsules
Proscar (finasteride) tablets
Prozac Pulvules (fluoxetine hydrochloride) capsules for oral use and Prozac Weekly (fluoxetine hydrochloride) delayed-release capsules
Renagel (sevelamer hydrochloride) tablets and Renvela (sevelamer carbonate) powder for oral suspension and tablets
Simcor (niacin extended-release/simvastatin) tablets
Sumavel DosePro (sumatriptan) injection for subcutaneous use
Talacen (pentazocine hydrochloride and acetaminophen) tablets
Tekturna HCT (aliskiren/hydrochlorothiazide) tablets
Torisel (temsirolimus) injection
Ultracet (tramadol HCl/acetaminophen) tablets
Venofer (iron sucrose) injection
Vimovo (naproxen/esomeprazole magnesium) tablets
Vytorin (ezetimibe/simvastatin) tablets
Zmax (azithromycin extended release) for oral suspension
Zocor (simvastatin) tablets
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