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

The MedWatch August 2011 Safety Labeling Changes posting includes 44 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:



The Following Drugs are Affected:

• 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

The "Summary Page" provides a listing of drug names and safety labeling sections revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm268289.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.

Drug Safety Data: How to Analyze, Summarize, and Interpret to Determine Risk

Cobert's Manual of Drug Safety and Pharmacovigilance

The Future of Drug Safety