> ## Content Index
> Fetch the complete content index at: https://www.foodconsumer.org/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA MedWatch - June 2014 Safety Labeling Changes includes 52 products with revisions to Prescribing Information
- URL: https://www.foodconsumer.org/fda_medwatch_0715141105/
- Published: 2014-07-15T12:05:00.000Z
- Updated: 2026-09-22T16:32:23.000Z
- Description: The posting covers 37 products with changes to boxed warnings, contraindications, warnings, precautions, adverse reactions and patient package inserts. Affected drugs include several testosterone products, Benicar, Herceptin, Prolia, Sutent and Thalomid.
- Author: Food Consumer
- Tags: Miscellaneous, Health News, #vivvo-import

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)