Safety Information > June 2011

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
full-text ►
Safety Information > June 2011: "June 2011

The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. The “quick view” table below provides the drug name and sections modified. Click on the drug name to go to the detailed view. The detailed view includes sections and subsections modified, a description of new or modified safety information in the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS sections, and a link to the revised prescribing information.

Key to Label Section Acronyms:

BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS, AR=ADVERSE REACTIONS, PPI/MG=PATIENT PACKAGE INSERT/MEDICATION GUIDE

Safety Information > June 2011: "June 2011 - Enviado mediante la barra Google"