Drug Safety Labeling Changes - July 2009

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July 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
Chantix (varenicline) 0.5 mg and 1 mg tabletsBoxed Warning-WarningsPrecautionsAdverse Reactions---
Wellbutrin (bupropion hydrochloride) tablets, Sustained-Release, and Extended Release (XL) tablets Boxed Warning-WarningsPrecautions----
Diabeta (glyburide) tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Lopid (gemfibrozil) tablets-Contraindications-Precautions----
Ortho Evra (norelgestromin / ethinyl estradiol) transdermal system-ContraindicationsWarnings-Adverse Reactions---
Veramyst (fluticasone furoate) nasal spray-ContraindicationsWarningsPrecautionsAdverse Reactions---
Gardasil (Human Papillomavirus Quadrivalent Types 6, 11, 16, 18) Recombinant Vaccine--WarningsPrecautions----
Letairis (ambrisentan) 5 and 10 mg tablets--WarningsPrecautions----
Myfortic (mycophenolic acid) 180 mg and 360 mg delayed-release tablet--Warnings-Adverse Reactions---
Rilutek (riluzole) tablets--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Soliris (eculizumab)--WarningsPrecautionsAdverse Reactions---
Abilify (aripiprazole) 9.75 mg / 1.3 mL (7.5 mg /mL) Injection---Precautions----
Calan (verapamil hydrochloride) tablets---Precautions----
Cardura (doxazosin mesylate) 1, 2, 4, and 8 mg tablets---Precautions----
Geodon (ziprasidone) 20 mg, 40 mg, 60 mg, and 80 mg capsules and 20 mg base /mL injection---Precautions----
Haldol (haloperidol) 5 mg base /mL injection and Haldol Decanoate (haloperidol) 50 mg base /mL and 100 mg base /mL IM injection---Precautions----
Hytrin (terazosin hydrochloride) 1, 2, 5, and 10 mg tablets---Precautions----
Invega (paliperidone) 1.5 mg, 3 mg, 6 mg, and 9 mg Extended-Release tablets---Precautions----
Isoptin SR (verapamil HCL) 120 mg, 180 mg, and 240 mg Sustained Release tablets---Precautions----
Minipress (prazosin hydrochloride) 1, 2, and 5 mg capsules---Precautions----
Drug Name BW C W P AR PPI MG PCI
Moban (molindone) 5 mg, 10 mg, 25 mg, and 50 mg tablets---Precautions----
Navane (thiothixene) 2 mg base/mL and 10 mg base/mL injectable---Precautions----
Pamidronate disodium injection---PrecautionsAdverse Reactions---
Phisohex (hexachlorophene 3%) detergent cleanser---Precautions----
Risperdal M-TAB (risperidone) 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg Orally Disintegrating tablets---Precautions----
Alimta (pemetrexed disodium) Injection, Powder, Lyophilized for Intravenous Use 100 mg and 500 mg vial----Adverse Reactions---
Caduet (amlodipine besylate/atorvastatin calcium) tablets----Adverse Reactions---
Ditropan XL (oxybutynin chloride, USP) Extended Release tablets----Adverse Reactions---
Femara (letrozole) 2.5 mg tablets----Adverse Reactions---
Isentress (raltegravir potassium) tablets----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Baraclude (entecavir) tablets and oral solution-----Patient Package Insert--
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