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Drug Safety Labeling Changes - June 2016

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June 2016

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
Elitek (rasburicase)Boxed Warning-WarningsPrecautionsAdverse Reactions---
Sabril (vigabatrin) Tablet Sabril (vigabatrin) Oral SolutionBoxed Warning-WarningsPrecautionsAdverse Reactions---
Xigduo XR (dapagliflozin and metformin HCl extended-release)Boxed WarningContraindicationsWarningsPrecautionsAdverse Reactions---
Aubagio (teriflunomide)-ContraindicationsWarningsPrecautionsAdverse Reactions---
Farxiga (dapagliflozin)-ContraindicationsWarningsPrecautionsAdverse Reactions---
Hectorol (doxercalciferol)-ContraindicationsWarnings-Adverse Reactions---
Nitromist (nitroglycerin)-Contraindications-Precautions----
Technivie (ombitasvir, paritaprevir and ritonavir) Tablets-Contraindications-Precautions----
Tybost (cobicistat)-ContraindicationsWarningsPrecautions----
Afinitor (everolimus)--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Bendeka (bendamustine hydrochloride)--WarningsPrecautionsAdverse Reactions---
Children's Motrin (ibuprofen)--Warnings-----
Farydak (panobinostat) --WarningsPrecautions----
Humira (adalimumab)--WarningsPrecautionsAdverse Reactions---
Iclusig (ponatinib hydrochloride)--WarningsPrecautionsAdverse Reactions---
Lybrel (levonorgestrel and ethinyl estradiol)--Warnings-----
Natpara (parathyroid hormone)--WarningsPrecautions----
Orfadin (nitisinone)--WarningsPrecautionsAdverse Reactions---
Prezista (darunavir) Tablet and Oral Suspension--WarningsPrecautionsAdverse Reactions---
Stivarga (regorafenib)--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Tamiflu (oseltamivir phosphate) Capsules and Oral Suspension--WarningsPrecautionsAdverse Reactions---
Tyvaso (treprostinil)--WarningsPrecautionsAdverse Reactions---
Zosyn (piperacillin and tazobactam for injection) and Zosyn (piperacillin sodium and tazobactam sodium injection)--WarningsPrecautionsAdverse Reactions---
Avycaz (ceftazidime and avibactam)---PrecautionsAdverse Reactions---
Cardura (doxazosin)---Precautions----
Cerebyx (fosphenytoin sodium)---Precautions----
Dilantin (phenytoin) Injection, Dilantin (phenytoin) Oral Suspension---PrecautionsAdverse Reactions---
Envarsus XR (tacrolimus extended release)---Precautions----
Kuvan (sapropterin dihydrochloride)---PrecautionsAdverse Reactions---
Pomalyst (pomalidomide)---PrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Tivicay (dolutegravir)---Precautions----
Viekira PAK (ombitasvir, paritaprevir and ritonavir tablets; dasabuvir tablets)---Precautions----
DEPO-PROVERA (medroxyprogesterone acetate)----Adverse Reactions---
Elelyso (taliglucerase alfa)----Adverse Reactions---
Imbruvica (ibrutinib)----Adverse Reactions---
Opsumit (macitentan)----Adverse Reactions---
Seroquel (quetiapine fumarate) and Seroquel XR (quetiapine fumarate)----Adverse Reactions---
Xyzal (levocetirizine dihydrochloride Oral Tabs)Xyzal (levocetirizine dihydrochloride Oral Solution)----Adverse Reactions---
Zaltrap (ziv-aflibercept) Injection----Adverse Reactions---
Zyban (Bupropion Hydrochloride)----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
LUPRON DEPOT (leuprolide acetate for depot suspension)--------
Neupogen (filgrastim)--------
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