August 2011 Medication Label Changes

Last month brought changes to forty-five (45) medical product labels, with changes to the prescribing information to include any of the following areas: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

For a complete detailed accounting of the label changes, please refer to the following summary.
By clicking onto the drug name, you will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.


The following drugs have been effected:

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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