FDA MedWatch - April 2015 Safety Labeling Changes includes 55 products with revisions to Prescribing Information

Safety Information > April 2015

The MedWatch April 2015 Safety Labeling Changes posting includes 55 products with safety labeling changes to the following sections:BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE.

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

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm446032.htm

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

Actonel (risedronate sodium) Tablets
Actonel with Calcium (risedronate sodium tablets with calcium carbonate tablets, USP)
Adcirca (tadalafil) Tablets
Arthrotec (diclofenac sodium/misoprostol) Oral Tablets
Atelvia (risedronate sodium) Delayed-release Tablets
Bidil (isosorbide dinitrate/hydralazine hydrochloride) Tablets
Binosto (alendronate sodium) Effervescent Tablets for Oral Solution
Boniva (ibandronate sodium) Injection
Boniva (ibandronate sodium) Tablets
Didronel (etidronate disodium) Tablets
Edarbyclor (azilsartan medoxomil/chlorthalidone)
Erbitux (cetuximab)
Flucelvax (Influenza Vaccine)
Fosamax (alendronate sodium) Tablets and Oral Solution
Fosamax Plus D (alendronate sodium/cholecalciferol) Tablets
Herceptin (trastuzumab)
Lotrel (amlodipine besylate and benazepril hydrochloride) Capsules
Olysio (simeprevir) Capsules
Pomalyst (pomalidomide) Capsules
Prolia (denosumab)
Revatio (sildenafil) Tablets, Single Use Vials for Injection, and Oral Suspension
Selzentry (maraviroc)
Sporanox (itraconazole) Capsules and Oral Solution
Sutent (sunitinib malate)
Tudorza Pressair (aclidinium bromide inhalation powder)
Votrient (pazopanib) Tablets

Safety Information > April 2015