Drug Safety Labeling Changes - August 2009

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August 2009

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
DexFerrum (iron dextran) 50 mg/mL injectionBoxed Warning--Precautions----
INFeD (iron dextran) 50 mg elemental iron/mL injectionBoxed Warning--Precautions----
Tasigna (nilotinib) capsulesBoxed Warning-WarningsPrecautions----
Arixtra (fondaparinux sodium) injection--WarningsPrecautionsAdverse Reactions---
Flagyl (metronidazole) 500 mg I.V. injection RTU (in plastic container)--Warnings-Adverse Reactions---
Inomax (nitric oxide) for Inhalation--WarningsPrecautions----
Lariam (mefloquine hydrochloride) 250 mg tablets--WarningsPrecautionsAdverse Reactions---
Letairis (ambrisentan) 5 and 10 mg tablets--WarningsPrecautionsAdverse Reactions---
Lopressor HCT (metoprolol tartrate and hydrochlorothiazide) tablets--Warnings-----
Merrem (meropenem) I.V. for injection--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Primaxin (imipenem and cilastatin) IM injectable suspension--WarningsPrecautions----
Pristiq (desvenlafaxine) extended-release tablets--WarningsPrecautionsAdverse Reactions---
Tobramycin 1.2 gram/50mL vial for injection--WarningsPrecautions----
Accolate (zafirlukast) tablets---PrecautionsAdverse Reactions---
Diabinese (chlorpropamide) tablets---Precautions----
Geodon (ziprasidone) 10 mg/mL oral suspension ---Precautions----
Glucotrol and Glucotrol XL (glipizide) tablets---Precautions----
Glynase (micronized glyburide) tablets---Precautions----
Metaglip (glipizide/metformin HCl fixed-dose combination) tablets---Precautions----
Micardis (telmisartan) tablets and Micardis HCT (telmisartan/HCTZ) tablets---PrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Serostim/Zorbtive (somatropin [rDNA origin] for injection)---Precautions----
Singulair (montelukast sodium) tablets, chewable tablets and oral granules---PrecautionsAdverse ReactionsPatient Package Insert--
Symbyax (olanzapine and fluoxetine hydrochloride) capsules---Precautions----
Ventavis (iloprost) 10 mcg/mL inhalation solution---Precautions----
Zyflo (zileuton) tablets and Zyflo CR (zileuton)  extended-release tablets---PrecautionsAdverse Reactions---
Zyprexa (olanzapine) tablets, orally disintegrating tablets and IM injection---Precautions----
Biaxin (clarithromycin) filmtabs, granules, and XL filmtabs----Adverse Reactions---
Dipentum (olsalazine sodium) 250 mg capsules----Adverse Reactions---
Orencia (abatacept) powder for injection----Adverse Reactions---
Zemplar (paricalcitol) 2 mcg/mL and 5 mcg/mL injection----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Nplate (romiplostim) for subcutaneous injection--------
Tracleer (bosentan) 62.5 and 125 mg tablets--------
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