MedWatch March 2011 Safety Labeling Changes posting includes 55 products


The MedWatch March 2011 Safety Labeling Changes posting includes 55 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:

Accuretic (quinapril HCL/hydrochlorothiazide)     
Advil Cold & Sinus Liqui-Gels (ibuprofen 200 mg and pseudoephedrine HCl 30 mg)           
Atacand HCT (candesartan cilexitil/hydrochlorothiazide)      
Azasite (azithromycin)  
Dutoprol (metoprolol succinate extended release/hydrochlorothiazide)     
Dyazide (hydrochlorothiazide/triamterene)         
Etopophos (etoposide phosphate)
Fareston (toremifene citrate)      
Inderal (propranolol HCL)
Inderal LA (propranolol hydrochloride)      
Inderide (propranolol hydrochloride/hydrochlorothiazide)      
Integrilin (eptifibatide)   
Letairis (ambrisentan)
Lioresal (baclofen)    
Lopressor (metoprolol tartrate)
Lopressor HCT (metoprolol tartrate/hydrochlorothiazide)      
Lotensin HCT (benazapril hydrochloride/hydorchlorothiazide)      
Maxzide and Maxzide-25 (triamterene/hydrochlorothiazide) and     
Microzide (hydrochlorothiazide)     
Ortho Evra (norelgestromin/ethinyl estradiol)
PhosLo (calcium acetate)    
Rotarix (Rotavirus Vaccine, Live, Oral)  
Sectral (acebutolol hydrochloride)      
Strattera (atomoxetine hydrochloride)
Talacen (pentazocine hydrochloride and acetaminophen)  
Tekamlo (aliskiren/amlodipine) 
Topamax (topiramate) 
Tribenzor (olmesartan medoxomil / amlodipine / hydrochlorothiazide)       
Vaseretic (enalapril maleate/hydrochlorothiazide)     
Yaz (drospirenone/ethinyl estradiol)    
Zestoretic (lisinopril/hydrochlorothiazide)

This entry was posted in Consumer Products, FDA 2011, FDA Notice and tagged , , , . Bookmark the permalink.