The May 2011 MedWatch posting includes 47 products with safety labeling changes to the following sections:

• Boxed warnings
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Patient package insert
• Medication guide

The May 2011 "Summary Page" on the FDA website provides a listing of drug names and safety labeling sections revised.

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, contradictions and warnings sections:

Aciphex (rabeprazole sodium) delayed-release tablets
Afinitor (everolimus) tablets
Aldactazide (spironolactone/hydrochlorothiazide) tablets
Avandia (rosiglitazone maleate)
Avandamet (rosiglitazone maleate/metformin hydrochloride)
Avandaryl (rosiglitazone maleate/glimepiride) tablets
Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) tablets
Biaxin Filmtab (clarithromycin tablets, USP), Biaxin XL Filmtab (clarithromycin extended-release tablets), Biaxin granules (clarithromycin for oral suspension, USP)
Dexilant (dexlansoprazole) delayed release capsules
Genotropin (somatropin [rDNA origin] for injection
Humalog (insulin lispro [rDNA origin]) injection
Imuran (azathioprine) tablets and injection
Levatol (penbutolol sulfate) tablets
Micardis HCT (telmisartan/hydrochlorothiazide) tablets
Norditropin Cartridges (somatropin [rDNA origin] injection)
Omeprazole / sodium bicarbonate / magnesium hydroxide tablets
Prevacid(Lansoprazole) delayed-release capsules
Prevacid SoluTab (Lansoprazole) delayed-release orally disintegrating tablets
Prilosec (omeprazole) delayed release capsules and Prilosec (omeprazole magnesium) for delayed release oral suspension
Protonix (pantoprazole sodium) for delayed-release oral suspension 40 mg, Protonix (pantoprazole sodium) delayed-release tablets, and Protonix I.V. (pantoprazole sodium) for injection
Purinethol (mercaptopurine) tablets
Seroquel (quetiapine fumarate) and Seroquel XR (quetiapine fumarate) extended-release tablets
Sutent (sunitinib malate) capsules
Teveten HCT (eprosartan mesylate/hydrochlorothiazide) tablets
Uniretic (moexipril hydrochloride/hydrochlorothiazide)
Vimovo (naproxen/esomeprazole magnesium) tablets
Zegerid (omeprazole/sodium bicarbonate) capsules and powder for oral suspension
Ziac (bisoprolol fumarate/hydrochlorothiazide) tablets

Doug Beardsley
952.851.2489
dbeardsl@careproviders.org

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