Drug Safety Labeling Changes - October 2008

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October 2008

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
Avelox I.V. (moxifloxacin hydrochloride in sodium chloride injection)Boxed Warning-WarningsPrecautions----
Cipro I.V. (ciprofloxacin) for Intravenous InfusionBoxed Warning-WarningsPrecautions----
Cipro (ciprofloxacin hydrochloride) TabletsBoxed Warning-WarningsPrecautions----
Cipro (ciprofloxacin) Oral SuspensionBoxed Warning-WarningsPrecautions----
Cipro XR (ciprofloxacin extended-release tablets)Boxed Warning-WarningsPrecautions----
Factive (gemifloxacin mesylate) TabletsBoxed Warning-WarningsPrecautionsAdverse Reactions---
Floxin (ofloxacin) TabletsBoxed Warning-WarningsPrecautions----
Levaquin (levofloxacin) Injection, for Intravenous UseBoxed Warning-WarningsPrecautions----
Levaquin (levofloxacin in 5% dextrose) Injection, for Intravenous UseBoxed Warning-WarningsPrecautions----
Noroxin (norfloxacin) TabletsBoxed Warning-WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Ontak (denileukin difttox) Solution for Intravenous UseBoxed Warning-WarningsPrecautionsAdverse Reactions---
Raptiva (efalizumab) for Injection, SubcutaneousBoxed Warning-WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Regranex (becaplermin) Gel 0.01 %Boxed Warning-Warnings-----
Apidra (insulin glulisine [rDNA origin] injection) Solution for Injection-ContraindicationsWarningsPrecautionsAdverse ReactionsPatient Package Insert--
Norditropin Cartridges [somatropin (rDNA origin) injection], for Subcutaneous Use-ContraindicationsWarningsPrecautionsAdverse ReactionsPatient Package Insert--
(lansoprazole delayed-release 15 mg capsules and naproxen 500 mg tablets kit)-ContraindicationsWarningsPrecautionsAdverse Reactions---
Prezista (darunavir) Tablets-ContraindicationsWarningsPrecautionsAdverse ReactionsPatient Package Insert--
Rozerem (ramelteon) Tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Soma Compound with Codeine (carisoprodol, aspirin, and codeine phosphate, USP) Tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Zomig (zolmitriptan) Nasal Spray-ContraindicationsWarningsPrecautionsAdverse ReactionsPatient Package Insert--
Drug Name BW C W P AR PPI MG PCI
Arixtra (fondaparinux sodium) Injection--WarningsPrecautionsAdverse Reactions---
Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Avandia (rosiglitazone maleate) Tablets--WarningsPrecautions----
Clolar (clofarabine) Injection for Intravenous Use--WarningsPrecautionsAdverse Reactions---
Cordarone (amiodarone HCl) Tablets--WarningsPrecautionsAdverse Reactions---
Exjade (deferasirox) Tablets for Oral Suspension--WarningsPrecautions-Patient Package Insert--
Ortho Evra (norelgestromin / ethinyl estradiol transdermal system)--Warnings-----
Pamidronate Disodium (pamidronate disodium injection) Solution for Intravenous Infusion--WarningsPrecautionsAdverse Reactions---
Pamidronate Disodium (pamidronate disodium injection) Powder, Lyophilized, for Solution for Intravenous Infusion--WarningsPrecautionsAdverse Reactions---
Precedex (dexmedetomidine hydrochloride) Injection for Intravenous Infusion [following dilution]--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Sutent (sunitinib malate) Capsules--WarningsPrecautionsAdverse Reactions---
Treanda (bendamustine hydrochloride) for Injection, for Intravenous Infusion--WarningsPrecautionsAdverse Reactions---
Atrovent (ipratropium bromide) Nasal Spray, Metered ---Precautions----
Cefazolin for Injection USP and Dextrose Injection USP---Precautions----
Cosopt (dorzolamide hydrochloride-timolol maleate ophthalmic solution)---Precautions----
Diabinese (chlorpropamide) Tablets, USP---Precautions----
Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules---Precautions----
Fosrenol (lanthanum carbonate) Chewable Tablets---Precautions----
Glynase PresTab (micronized glyburide tablets)---Precautions----
Hylenex recombinant (hyaluronidase human injection)---Precautions----
Drug Name BW C W P AR PPI MG PCI
Kaletra (lopinavir and ritonavir) Tablet, Film Coated for Oral Use---Precautions----
Kaletra (lopinavir and ritonavir) Solution for Oral Use---Precautions----
Micronase (glyburide tablets, USP)---Precautions----
Norvir (ritonavir) Capsules and Solution---Precautions----
Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets---Precautions----
Prevacid (lansoprazole) Delayed-Release Capsules---Precautions----
Prevacid (lansoprazole) For Delayed-Release Oral Suspension---Precautions----
Prevacid SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets---Precautions----
Riomet (metformin hydrochloride oral solution)---Precautions----
Skelaxin (metaxalone) Tablets---Precautions----
Drug Name BW C W P AR PPI MG PCI
Tenoretic (atenolol and chlorthalidone) Tablets---Precautions----
Theophylline in 5% Dextrose Injections USP---Precautions----
Theophylline in 5% Dextrose Injection (theophylline injection, solution) USP, in Flexible Plastic Container---Precautions----
Theophylline in Dextrose (theophylline anhydrous injection, solution) USP, in VIAFLEX Plus Container---Precautions----
Tobi (tobramycin inhalation solution, USP) Nebulizer Solution - For Inhalation Use Only---Precautions----
Trusopt (dorzolamide hydrochloride ophthalmic solution) ---Precautions----
Janumet (sitagliptin and metformin hydrochloride) Tablets----Adverse Reactions---
Januvia (sitagliptin) Tablets----Adverse Reactions---
Lexapro (escitalopram oxalate) Tablets and Oral Solution----Adverse Reactions---
Myambutol (ethambutol hydrochloride) Tablets----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Proquin XR (ciprofloxacin hydrochloride) Extended-Release Tablets--------
Requip XL (ropinirole extended-release tablets)-----Patient Package Insert--
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