FDA: Safety Labeling Changes Made to Prescribing Information for 44 Products in August

The U.S. Food and Drug Administration has published safety labeling changes made prescribing information for 44 products in August.

 

Changes were made to 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:

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

 

To view a listing of drug names and safety labeling sections revised, click here. 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.

 

Related Articles on Medication Safety:

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Staff Education Tool: Medication Safety Reconciliation Toolkit

ULCA, Harvard Study Shows Results of Medication Studies May Be Misleading

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