June 2011 Safety Labeling Changes: 50 products with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions

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