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Tuesday, September 13, 2011

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:
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.

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