August 2011 Safety Labeling Changes

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August 2011 Safety Labeling Changes: 44 Medical Product Labels with changes to Prescribing Information

The MedWatch August 2011 Safety Labeling Changes posting includes 45 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:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm242998.htm

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:

Accolate (zafirlukast) tablets
Actos (pioglitazone hydrochloride) Tablets
Bentyl (dicyclomine hydrochloride, USP) Capsules/Tablets, Oral Syrup and Injection
Betapace and Betapace AF (sotalol HCl) Tablets
BiCNU (carmustine for injection)
Celexa (citalopram hydrobromide) Tablets and  Oral Solution
DepoCyt (cytarabine liposome injection)  
Ditropan (Oxybutynin chloride) Tablets
Dostinex (cabergoline) Tablets
Exjade (deferasirox) Tablets for Oral Suspension
Haldol (haloperidol) Injection and Haldol Decanoate (haloperidol) IM Injection
Hyzaar (losartan/hydrochlorothiazide) Tablets
Kerledex (betaxolol hydrochloride/chlorthalidone) Tablets
Kerlone (betaxolol hydrochloride) Tablets
Lamictal (lamotrigine) Tablets, Chewable Dispersible Tablets, Lamictal  Orally Disintegrating Tablets, and Lamictal XR Extended-Release Tablets
Mobic (meloxicam) Tablets and Oral Suspension
Multaq (dronedarone hydrochloride) Tablets
Neurontin (gabapentin) Capsules, Tablets, and Oral Solution
Platinol (cisplatin for injection, USP)
Prinzide (lisinopril/hydrochlorothiazide) Tablets
Reclast (zoledronic acid) Injection
Saphris (asenapine)  Sublingual Tablets
Sensipar (cinacalcet) Tablets
Tenoretic (atenolol/chlorthalidone) Tablets
Tenormin (atenolol) Tablets
Tenoretic (atenolol/chlorthalidone) Tablets
Thallous Chloride [Tl-201] Injection
Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate

 

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