MedWatch May 2011 Safety Labeling Changes


The MedWatch May 2011 Safety Labeling Changes posting includes 47 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:

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:

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 and Protonix (pantoprazole sodium) Delayed-Release Tablets, Protonix I.V. (pantoprazole sodium) for Injection
Purinethol (mercaptopurine) Tablets
Seroquel (quetiapine fumarate) and Seroquel XR (quetiapine fumarate) Extended-ReleaseTablets
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


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