Drug Safety Labeling Changes - March 2009

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March 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
Epzicom (abacavir sulfate and lamivudine) tabletsBoxed WarningContraindicationsWarningsPrecautions----
OsmoPrep (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) TabletsBoxed Warning---Adverse Reactions---
Raptiva (efalizumab)Boxed WarningContraindicationsWarningsPrecautionsAdverse Reactions---
Sporanox (itraconazole) Oral Solution, 10 mg/mLBoxed WarningContraindicationsWarningsPrecautionsAdverse Reactions---
Trizivir (abacavir sulfate, lamivudine, and zidovudine) TabletsBoxed WarningContraindicationsWarningsPrecautions----
Visicol (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP)Boxed Warning---Adverse Reactions---
Macrobid (nitrofurantoin monohydrate/macrocrystals) capsules, 100 mg-Contraindications------
Macrodantin (nitrofurantoin macrocrystals) capsules, 25, 50 and 100 mg-ContraindicationsWarnings-----
Rocephin (ceftriaxone sodium) for injection, 250 mg, 500 mg, 1 g and 2 g-ContraindicationsWarnings-Adverse Reactions---
Sporanox (itraconazole) Capsules, 100 mg-ContraindicationsWarningsPrecautionsAdverse ReactionsPatient Package Insert--
Drug Name BW C W P AR PPI MG PCI
Sporanox (itraconazole) Injection, 10 mg/mL-ContraindicationsWarningsPrecautionsAdverse ReactionsPatient Package Insert--
Theophylline in 5% Dextrose injection, USP, Flexible Plastic Container-ContraindicationsWarningsPrecautionsAdverse Reactions---
Tracleer (bosentan) 62.5 and 125 mg Tablets-Contraindications-Precautions----
Advair Diskus (fluticasone propionate and salmeterol xinafoate inhalation powder)--WarningsPrecautions----
Altace (ramipril) 1.25, 2.5, 5, and 10 mg Capsules--WarningsPrecautions----
Altace (ramipril) 1.25, 2.5, 5 and 10 mg Tablets--WarningsPrecautions----
Axert (almotriptan malate) Tablets 6.25 and 12.5 mg--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules 20, 30 and 60 mg--WarningsPrecautionsAdverse Reactions---
Frova (frovatriptan succinate) Tablets 2.5 mg--WarningsPrecautionsAdverse Reactions---
Lexiscan (regadenoson) Injection--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Spiriva HandiHaler inhalation powder--Warnings-Adverse Reactions---
NegGram (nalidixic acid) Caplets---Precautions----
Novothyrox (levothyroxine sodium) Tablets---Precautions----
Tarka (trandolopril/verapamil hydrochloride) 2/180, 1/240, 2/240, 4/240 mg ER Tablets---Precautions----
Zithromax (azithromcyin) for Oral Suspension, 200 mg, 500 mg, Single Dose Packet, 600 mg, IV---Precautions----
Clinoril (sulindac) Tablets----Adverse Reactions---
Cosmegen (dactinomycin) for Injection----Adverse Reactions---
Crestor (rosuvastatin calcium) Tablets ----Adverse Reactions---
Demerol (meperidine hydrochloride) Tablets and Oral Solution----Adverse Reactions---
Eloxatin (oxaliplatin) powder for solution for intravenous use----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Eloxatin (oxaliplatin) concentrate for solution for intravenous use----Adverse Reactions---
Vancocin Hcl (vancomycin for injection, USP) 500 mg/100mL and 1g/200mL----Adverse Reactions---
Dalmane (flurazepam hydrochloride), 15 mg and 30 mg oral Capsules--------
Prozac (fluoxetine hydrochloride) capsules--------
Symbyax (olanzapine/fluoxetine) capsules--------
Synagis (palivizumab)-----Patient Package Insert--
Zyprexa (olanzapine) Tablet--------
Zyprexa Zydis (olanzapine) Tablet, Orally Disintegrating--------
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