Drug Safety Labeling Changes - April 2009

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April 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
Extraneal (icodextrin) Peritoneal Dialysis SolutionBoxed WarningContraindicationsWarningsPrecautionsAdverse Reactions---
Remicade (inflximab) IV InfusionBoxed Warning-Warnings-Adverse Reactions---
Orap (pimozide) 1 and 2 mg tablets-Contraindications-Precautions----
Prevpac (lansoprazole 30 mg/amoxicillin 500 mg/clarithromycin 500 mg)-Contraindications-PrecautionsAdverse Reactions---
Soma Compound (200 mg of carisoprodol and 325 mg of aspirin)-ContraindicationsWarningsPrecautionsAdverse Reactions---
Aleve (220 mg naproxen sodium) caplet, tablet, and gelcap [OTC]--Warnings-----
Aleve Liquid Gels (220 mg naproxen sodium) capsules--Warnings-----
Aleve-D Sinus & Cold and Aleve-D Sinus & Headache (naproxen sodium, 220 mg and pseudoephedrine HCl, 120 mg) extended-release tablets--Warnings-----
Axert (almotriptan) tablets--WarningsPrecautions----
Carbatrol (carbamazepine) Extended-Release Capsules--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Celontin (methsuximide) Capsules--WarningsPrecautions----
Depakene (valproic acid) Capsules and Oral Solution--WarningsPrecautions----
Depakote (divalproex sodium) Sprinkle Capsules--WarningsPrecautions----
Depo-Medrol (methylprednisolone acetate injectable suspension, USP)--WarningsPrecautionsAdverse Reactions---
Dilantin-125 (phenytoin oral suspension, USP) Suspension--WarningsPrecautions----
Doribax (doripenem for injection)--WarningsPrecautionsAdverse Reactions---
Enlon Plus (edrophonium chloride and atropine sulfate, USP) Injection--Warnings-----
Equetro (carbamazepine) Extended-Release Capsules--WarningsPrecautions----
Gabitril (tiagabine hydrochloride) Tablets--WarningsPrecautions----
Heparin Sodium Injection, USP--Warnings-----
Drug Name BW C W P AR PPI MG PCI
Ibuprofen 200 mg capsules--Warnings-----
Kaletra (lopinavir/ritonavir) 80 mg/20mg per ml Oral Solution--WarningsPrecautionsAdverse Reactions---
Keppra XR (levetiracetam) Extended-Release Tablets--WarningsPrecautions----
Klonopin (clonazepam orally disintegrating tablet) Wafers--WarningsPrecautions----
Lamictal (lamotrigine) Tablets and Chewable Dispersible Tablets--WarningsPrecautions----
Lyrica (pregabalin) Capsules--WarningsPrecautions----
Midol Extended Relief (220 mg naproxen sodium) caplet [OTC]--Warnings-----
Motrin--Warnings-----
Children’s Motrin Cold (100 mg/5 ml ibuprofen and 15 mg/5 ml pseudoephedrine HCl) suspension--Warnings-----
Mysoline (primidone) 50 mg and 250 mg Tablets--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Peganone (ethotoin) 250 mg Tablets--WarningsPrecautions----
Tarceva (erlotinib) Tablets--WarningsPrecautions----
Tegretol (carbamazepine) Tablets, Chewable Tablets, Suspension, and Extended-Release Tablets--WarningsPrecautions----
Topamax (topiramate) 25, 50, 100 and 200 mg Tablets and 15 mg and 25 mg Sprinkle Capsules--WarningsPrecautionsAdverse Reactions---
Tranxene (clorazepate dipotassium) Tablets--WarningsPrecautions----
Treanda (bendamustine hydrochloride) for Injection, 100 mg--WarningsPrecautions----
Tridione (trimethadione) Tablets--WarningsPrecautions----
Trileptal (oxcarbazepine) Tablets and Suspension--WarningsPrecautions----
Zonegran (zonisamide) Capsules--WarningsPrecautions----
Arava (leflunomide) oral tablets, 10mg, 20mg, 100mg---Precautions----
Drug Name BW C W P AR PPI MG PCI
CeeNu (lomustine) Capsules---Precautions----
Cordarone (amiodarone HCl) 200 mg Tablets---PrecautionsAdverse Reactions---
Glycet (miglitol) Tablets---Precautions----
Kayexalate (sodium polystyrene sulfonate, USP) Powder--------
Mavik (trandolopril) 1, 2, and 4 mg Tablets---Precautions----
Minipress (prazosin hydrochloride) 1, 2, and 5 mg Capsules---PrecautionsAdverse Reactions---
Copegasus-ß (ribavirin) 200 mg tablets in combination with Pegasys-ß (peginterferon alfa-2a)----Adverse Reactions---
Duraclon (clonidine hydrochloride) injection, solution----Adverse Reactions---
Metadate CD (methylphenidate HCl, USP) 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg Extended-Release Capsules----Adverse Reactions---
Mifeprex (mifepristone) Tablets----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Avelox (moxifloxacin hydrochloride in NaCl injection) I.V.--------
Detrol (tolterodine tartrate) tablets, 1 and 2 mg--------
Levaquin (levofloxacin) Oral Solution--------
Proquin XR (ciprofloxacin HCl extended-release) Tablets--------
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