FDA MedWatch - May 2011 Monthly Safety Labeling Changes includes 47 products with revisions to Prescribing Information

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
Companies in this article
More in Regulatory