March 2011 Safety Labeling Changes: 55 Medical Product Labels with changes to Warnings, Contraindications, Precautions, Adverse Reactions

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.

Apr 16th, 2011

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)

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