Fwd: FDA MedWatch - May 2014 Safety Labeling Changes includes 37 products with revisions to Prescribing Information

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From: FDA MedWatch <fda@service.govdelivery.com>
Date: Fri, Jun 13, 2014 at 12:29 PM
Subject: FDA MedWatch - May 2014 Safety Labeling Changes includes 37 products with revisions to Prescribing Information
To: iammejtm@gmail.com

The MedWatch May 2014 Safety Labeling Changes posting includes 37 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.

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

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm400227.htm

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

Accupril (quinapril)
Accuretic (quinapril HCl/hydrochlorothiazide)
Avandia (rosiglitazone maleate) tablets
Avandaryl (rosiglitazone maleate and glimepiride)
Avandamet (rosiglitazone maleate and metformin hydrochloride)  
Edurant (rilpivirine)
Jentadueto (linagliptin and metformin hydrochloride)
Soriatane (acitretin)
Tradjenta (linagliptin)
Apidra (insulin glulisine [rDNA origin]) 
Altace (ramipril)
Aromasin (exemestane)
Azilect (rasagiline mesylate)
Bydureon (exenatide extended-release)
Gemzar (gemcitabine)
Lunesta (eszopiclone)
Sustiva (efavirenz)
Temodar (temozolomide)
Temodar (temozolomide)
Adempas (riociguat)
Aloxi (palonosetron hydrochloride)
Avalide (irbesartan/hydrochlorothiazide)
Avapro (irbesartan)
Cleocin HCl (clindamycin hydrochloride)
Cleocin Phosphate (clindamycin phosphate)   
Colestid (colestipol HCl)
Humira (adalimumab)
Invokana (canagliflozin)
Tivicay (dolutegravir)
Xalkori (crizotinib)

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Jeremy Tobias Matthews