From: FDA MedWatch <fda@service.govdelivery.com>
Date: Tue, Jul 15, 2014 at 8:15 AM
Subject: FDA MedWatch - June 2014 Safety Labeling Changes includes 52 products with revisions to Prescribing Information
To: iammejtm@gmail.com
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The MedWatch June 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/ucm402776.htm
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections:
Alsuma (sumatriptan)
Androderm (testosterone)
AndroGel (testosterone) gel
Avalide (irbesartan and hydrochlorothiazide)
Aveed (testosterone undecanoate)
Axiron (testosterone)
Benicar (olmesartan medoxomil)
Benicar HCT (olmesartan medoxomil-hydrochlorothiazide)
Caverject (alprostadil for injection)
Caverject Impulse Dual Chamber System (alprostadil for injection)
Cerebyx (Fosphenytoin Sodium Injection)
Cleocin Phosphate (Clindamycin injection, USP) and (clindamycin injection in 5 percent dextrose)
Cleocin HCL (clindamycin hydrochloride)
Complera (emtricitabine, rilpivirine, tenofovir disoproxil fumarate)
Comtan (entacapone)
Delatestryl (testosterone enanthate)
Ella (ulipristal acetate)
Fortesta (testosterone) gel
Gazyva (obinutuzumab)
Herceptin (trastuzumab)
Hycamtin (topotecan)
Jetrea (ocriplasmin)
Lupron Depot (leuprolide acetate)
Nutropin AQ (somatropin [rDNA origin])
Prolia (denosumab)
Ravicti (glycerol phenylbutyrate)
Saizen (somatropin [rDNA origin])
Serostim (somatropin [rDNA origin] for injection)
Sporanox (itraconazole)
Striant (testosterone)
Sutent (sunitinib malate)
Symlin (pramlintide acetate)
Testim (testosterone)
Testosterone gel
Tev-Tropin (somatropin [rDNA origin])
Thalomid (thalidomide)
Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide)
Trileptal (oxcarbazepine)
Votrient (pazopanib)
Xgeva (denosumab)
Zestril (lisinopril)
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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Jeremy Tobias Matthews
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