Drug Safety Labeling Changes - February 2014

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February 2014

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
Promacta (eltrombopag) TabletsBoxed Warning-WarningsPrecautionsAdverse Reactions---
Nizoral (ketoconazole) Tablet Boxed Warning-WarningsPrecautions----
Bravelle (urofollitropin for injection, purified)-ContraindicationsWarningsPrecautions----
Juvisync (sitagliptin and simvastatin) Tablets-ContraindicationsWarningsPrecautions----
Menopur (menotropins for injection)-ContraindicationsWarningsPrecautions----
Mevacor (lovastatin)-ContraindicationsWarningsPrecautions----
Samsca (tolvaptan) Tablets -Contraindications--Adverse Reactions---
Vytorin (ezetimibe/simvastatin) Tablets-ContraindicationsWarningsPrecautions----
Zocor (simvastatin) Tablets-ContraindicationsWarningsPrecautions----
Afinitor (everolimus) Tablets for Oral AdministrationAfinitor Disperz (everolimus tablets for oral suspension)--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Agrylin (anagrelide hydrochloride) Capsules --WarningsPrecautions----
Aloxi (palonosetron hydrochloride) Injection --WarningsPrecautions----
Astagraf XL (tacrolimus extended-release capsules) --WarningsPrecautionsAdverse Reactions---
Imuran (azathioprine) Tablets and Imuran (azathioprine) Injection --Warnings-----
Lodosyn (carbidopa)--WarningsPrecautionsAdverse Reactions---
Simponi Aria (golimumab) Injection For Intravenous Use--WarningsPrecautions----
Victrelis (boceprevir) 200 mg capsules--WarningsPrecautionsAdverse Reactions---
Zelboraf (vemurafenib) Tablets--WarningsPrecautionsAdverse Reactions---
Biltricide (praziquantel) Tablets---PrecautionsAdverse Reactions---
Juxtapid (lomitapide) Capsules---Precautions----
Drug Name BW C W P AR PPI MG PCI
Nexium (esomeprazole magnesium) Delayed-Release Oral Suspension---Precautions----
Nexium I.V. (esomeprazole sodium) for Intravenous Injection---Precautions----
Prilosec (omeprazole) Delayed-Release Capsules---Precautions----
Prilosec (omeprazole magnesium) Delayed-Release Oral Suspension---Precautions----
Xarelto (rivaroxaban) Tablets---Precautions----
Zegerid (omeprazole/sodium bicarbonate) Powder for Oral Suspension---Precautions----
Zegerid (omeprazole/sodium bicarbonate) Capsules---Precautions----
Brovana (arformoterol tartrate) Inhalation Solution ----Adverse Reactions---
Lunesta (eszopiclone) Film Coated Oral Tablets----Adverse Reactions---
Ozurdex (dexamethasone intravitreal implant)----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Pepcid (famotidine) Tablet----Adverse Reactions---
Strattera (atomoxetine hydrochloride) Capsules----Adverse Reactions---
Janumet XR (sitagliptin and metformin HCl Extended-Release) Tablets --------
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