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Drug Safety Labeling Changes - June 2015

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June 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
Enjuvia (synthetic conjugated estrogens, B) Tablets Boxed WarningContraindicationsWarningsPrecautionsAdverse Reactions---
Hycamtin (Topotecan) InjectionBoxed Warning-------
Capoten (captopril) Tablets-ContraindicationsWarnings-----
Jevtana (cabazitaxel) Injection-ContraindicationsWarningsPrecautions----
Rocephin (ceftriaxone sodium) for Injection -ContraindicationsWarnings-Adverse Reactions---
Angeliq (drospirenone and estradiol) Tablets--WarningsPrecautions----
Banzel (rufinamide) Oral Tablets and Oral Suspension--WarningsPrecautionsAdverse Reactions---
Beyaz  (drospirenone/ethinylestradiol/levomefolate calcium) Tablets--WarningsPrecautions----
Cardura XL (doxazosin mesylate extended release tablets)--WarningsPrecautionsAdverse Reactions---
Doryx (doxycycline delayed release) Tablets--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Keytruda (pembrolizumab) Injection --WarningsPrecautionsAdverse Reactions---
Nexium 24HR (esomeprazole magnesium) Delayed-release Capsules (OTC)--Warnings-----
Omeprazole Delayed Release Tablets (OTC)--Warnings-----
Prevacid 24HR (lansoprazole) Delayed Release Capsules (OTC)--Warnings-----
Safyral (drospirenone/ethinylestradiol/levomefolate calcium) Tablets--WarningsPrecautions----
Vimovo (naproxen/esomeprazole magnesium) Delayed-Release Tablets--WarningsPrecautionsAdverse Reactions---
Xeljanz (tofacitinib) Tablets--WarningsPrecautions----
Xgeva (denosumab)--WarningsPrecautions----
Yasmin (drospirenone/ethinylestradiol) Tablets--WarningsPrecautions----
Yaz (drospirenone/ethinylestradiol) Tablets--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Zegerid (omeprazole, 20 mg and sodium bicarbonate, 1100mg) Capsules (OTC)--Warnings-----
Zometa (zoledronic acid) Injection--WarningsPrecautionsAdverse Reactions---
Cerebyx (fosphenytoin sodium) Injection---Precautions----
Crestor (rosuvastatin) Tablets---Precautions----
Cymbalta (duloxetine hydrochloride) Capsules---PrecautionsAdverse Reactions---
Depo-Provera (medroxyprojesterone acetate) Injectable Suspension---PrecautionsAdverse Reactions---
Eliquis (apixaban) Tablets---Precautions----
Kaletra (lopinavir/ritonavir) Capsules, Film-coated Tablets, Oral Solution ---Precautions----
Stiolto Respimat (tiotropium bromide and olodaterol) Inhalation Spray---Precautions----
Xenazine (tetrabenazine) Tablets----Adverse Reactions---
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