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Drug Safety Labeling Changes - May 2015

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May 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
Erivedge (vismodegib) CapsulesBoxed Warning-WarningsPrecautionsAdverse Reactions---
Lamictal (lamotrigine) TabletsLamictal (lamotrigine) Chewable Dispersible TabletsLamictal ODT (lamotrigine) Orally Disintegrating TabletsBoxed Warning-WarningsPrecautions----
Sirturo (bedaquiline) TabletsBoxed Warning-WarningsPrecautionsAdverse Reactions---
Prezista (darunavir) Tablet and Oral Suspension-Contraindications-Precautions----
Provera (medroxyprogesterone acetate) Tablets-Contraindications--Adverse Reactions---
Androderm (testosterone) Transdermal System--WarningsPrecautionsAdverse Reactions---
AndroGel (testosterone) Gel--WarningsPrecautionsAdverse Reactions---
Avastin (bevacizumab) Solution for Intravenous Infusion--WarningsPrecautions----
Aveed (testosterone undecanoate) Injection--WarningsPrecautionsAdverse Reactions---
Axiron (testosterone) Topical Solution--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) Tablet--WarningsPrecautionsAdverse Reactions---
Delatestryl (testosterone enanthate) Injection--WarningsPrecautionsAdverse Reactions---
Edurant (rilpivirine) Tablet--WarningsPrecautionsAdverse Reactions---
Fluvirin (influenza Vaccine)--WarningsPrecautionsAdverse Reactions---
Fortesta (testosterone) Gel--WarningsPrecautionsAdverse Reactions---
Gilenya (fingolimod) Capsules--WarningsPrecautions----
Intron A (interferon alfa-2b), Recombinant for Injection--WarningsPrecautionsAdverse Reactions---
Natesto (testosterone) Nasal Gel--WarningsPrecautionsAdverse Reactions---
Nicorette (nicotine polacrilex) Lozenges--Warnings-----
PegIntron (peginterferon alfa-2b), Injection for Subcutaneous Use--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Perjeta (pertuzumab) Injection, for Intravenous Use--WarningsPrecautions----
Rebetol (ribavirin) Capsules and Oral Solution--WarningsPrecautions----
Striant (testosterone buccal system) Mucoadhesive--WarningsPrecautionsAdverse Reactions---
Sylatron (peginterferon alfa-2b) for Injection, for Subcutaneous Use--WarningsPrecautionsAdverse Reactions---
Testim (testosterone) Gel--WarningsPrecautionsAdverse Reactions---
Testosterone Gel, for Topical Use--WarningsPrecautionsAdverse Reactions---
Trokendi XR (topiramate) Extended-release Capsules--WarningsPrecautions----
Tysabri (natalizumab) Injection, for Intravenous Use--WarningsPrecautions----
Vogelxo (testosterone) Gel--WarningsPrecautionsAdverse Reactions---
VPRIV (velaglucerase alfa for injection)--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Asacol (mesalamine) Delayed-release Tablets---Precautions----
Carnitor (levocarnitine) Tablets, Oral Solution, Sugar-free Oral Solution, Injection---Precautions----
Ceftazidime for Injection USP and Dextrose Injection USP---Precautions----
CombiPatch (estradiol/norethindrone acetate transdermal system)---PrecautionsAdverse Reactions---
Glynase PresTab (micronized glyburide) Tablets---Precautions----
Lotrel (amlodipine besylate/benazepril hydrochloride) Tablets---Precautions----
Micronase (glyburide) Tablets---Precautions----
Prograf (tacrolimus) Capsules and Injection---Precautions----
Veramyst (fluticasone furoate) Nasal Spray---Precautions----
Zymar (gatifloxacin) Ophthalmic Solution---Precautions----
Drug Name BW C W P AR PPI MG PCI
Elitek (rasburicase) Solution, for Intravenous Infusion----Adverse Reactions---
Xiaflex (collagenase clostridium histolyticum) for Injection, for Intralesional Use----Adverse Reactions---
Zytiga (abiraterone acetate) Tablets----Adverse Reactions---
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