Drug Safety Labeling Changes - April 2015

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April 2015

This monthly summary of drug label changes provides a quick view of the sections that have changed. Click on a drug name to view the changes in more detail.

Key to Label Sections
BW - Boxed Warning C - Contraindications W - Warnings P - Precautions
AR - Adverse Reactions PPI - Patient Package Insert MG - Medication Guide PCI - Patient Counseling Information

Sections Modified
Drug Name BW C W P AR PPI MG PCI
Pomalyst (pomalidomide) CapsulesBoxed Warning-WarningsPrecautionsAdverse Reactions---
Sporanox (itraconazole) Capsules and Oral SolutionBoxed WarningContraindications-PrecautionsAdverse Reactions---
Adcirca (tadalafil) Tablets-Contraindications------
Bidil (isosorbide dinitrate/hydralazine hydrochloride) Tablets-Contraindications-Precautions----
Revatio (sildenafil) Tablets, Single Use Vials for Injection, and Oral Suspension-Contraindications------
Actonel (risedronate sodium) Tablets--WarningsPrecautions----
Actonel with Calcium (risedronate sodium tablets with calcium carbonate tablets, USP)--WarningsPrecautions----
Arthrotec (diclofenac sodium/misoprostol) Oral Tablets--Warnings-Adverse Reactions---
Atelvia (risedronate sodium) Delayed-release Tablets--WarningsPrecautions----
Binosto (alendronate sodium) Effervescent Tablets for Oral Solution--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Boniva (ibandronate sodium) Injection--WarningsPrecautions----
Boniva (ibandronate sodium) Tablets--WarningsPrecautions----
Didronel (etidronate disodium) Tablets--WarningsPrecautions----
Edarbyclor (azilsartan medoxomil/chlorthalidone)--WarningsPrecautions----
Erbitux (cetuximab)--WarningsPrecautions----
Fosamax (alendronate sodium) Tablets and Oral Solution--WarningsPrecautions----
Fosamax Plus D (alendronate sodium/cholecalciferol) Tablets--WarningsPrecautions----
Flucelvax (Influenza Vaccine)--WarningsPrecautionsAdverse Reactions---
Herceptin (trastuzumab)--WarningsPrecautions----
Lotrel (amlodipine besylate and benazepril hydrochloride) Capsules--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Olysio (simeprevir) Capsules--WarningsPrecautionsAdverse Reactions---
Prolia (denosumab)--WarningsPrecautions----
Selzentry (maraviroc)--WarningsPrecautions----
Sutent (sunitinib malate)--WarningsPrecautions----
Tudorza Pressair (aclidinium bromide inhalation powder)--WarningsPrecautions----
Votrient (pazopanib) Tablets--WarningsPrecautionsAdverse Reactions---
Dolophine (methadone) Tablets---Precautions----
Phoslyra (calcium acetate) Oral Solution---Precautions----
Primaquine (primaquine phosphate) Tablets---PrecautionsAdverse Reactions---
Adderall (mixed salts of a single-entity amphetamine product) Tablets----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Adderall XR (dextroamphetamine mixed salts of a single entity amphetamine product) Capsules----Adverse Reactions---
Concerta (methylphenidate HCl) Extended-release Tablets----Adverse Reactions---
Daytrana (methylphenidate transdermal system)----Adverse Reactions---
Desoxyn (methamphetamine hydrochloride) Tablets----Adverse Reactions---
Dexedrine (dextroamphetamine sulfate) Spansule Sustained Release Capsules----Adverse Reactions---
Duac (clindamycin phosphate and benzoyl peroxide) Gel----Adverse Reactions---
Focalin (dexmethylphenidate HCl) Tablets----Adverse Reactions---
Focalin XR (dexmethylphenidate HCl) Extended-release Tablets----Adverse Reactions---
Invirase (saquinavir mesylate) Capsules and Tablets----Adverse Reactions---
Janumet (sitagliptin and metformin HCl) Tablets----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Janumet XR (sitagliptin and metformin extended release) Tablets----Adverse Reactions---
Januvia (sitagliptin) Tablets----Adverse Reactions---
Metadate CD (methylphenidate HCl) Extended-Release Capsules----Adverse Reactions---
Methylin (methylphenidate) Chewable Tablets----Adverse Reactions---
Methylin (methylphenidate) Oral Solution ----Adverse Reactions---
Opsumit (macitentan) Tablets----Adverse Reactions---
Quillivant XR (methylphenidate hydrochloride) Extended-release Oral Suspension----Adverse Reactions---
Reclast (zoledronic acid) Injection----Adverse Reactions---
Ritalin (methylphenidate hydrochloride) Tablets ----Adverse Reactions---
Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules ----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets  ----Adverse Reactions---
Strattera (atomoxetine hydrochloride) Capsules----Adverse Reactions---
Stivarga (regorafenib) Tablets----Adverse Reactions---
Temodar (temozolomide) for Injection----Adverse Reactions---
Vyvanse (lisdexamfetamine dimesylate) Capsules----Adverse Reactions---
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