Safety Information > November 2010

The MedWatch November 2010 Safety Labeling Changes posting includes 37 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/ucm233345.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:

Adderall XR (dextroamphetamine mixed salts of a single-entity amphetamine product) Capsules
Anectine (succinylcholine chloride injection, USP)
Arduan (pipecuronium bromide) Injection
Cardizem CD (diltiazem hydrochloride) Capsules and Tablets, Cardizem LA (diltiazem hydrochloride) Extended-Release Tablets
Feraheme (ferumoxytol) Injection
Metopirone (metyrapone USP) 250 mg, Capsules
Metosolv ODT (metoclopramide hydrochloride)
Mivacron (mivacurium chloride) Injection
Nimbex (cisatracurium besylate) Injection
Norcuron (vecuronium bromide) Injection
Nuromax (doxacurium chloride) Injection
Pavulon (pancuronium bromide) Injection
Quelicin (succinylcholine chloride injection, USP)
Rapamune (sirolimus) oral solution and tablets
Raplon (rapacuronium bromide) Injection
Reglan (metoclopramide) tablets, ODT (Orally Disintegrating Tablets), and injection
Revatio (sildenafil) Tablets and Injection
Rifadin (rifampin capsules USP), and Rifadin (rifampin for injection USP) IV
Rifater (rifampin, isoniazid and pyrazinamide) Tablets
Rozerem (ramelteon) Tablets
Tiazac (diltiazem hydrochloride) Extended Release Capsules
Trandate (labetalol hydrochloride) Tablets and Injection
Vfend (voriconazole) Tablets, Injection, and Oral Suspension
Vyvanse (lisdexamfetamine dimesylate) Capsules
Zemuron (rocuronium bromide) Injection

Safety Information > November 2010