Drug Safety Labeling Changes - September 2009

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September 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
Rapamune (sirolimus) oral solution and tabletsBoxed Warning-WarningsPrecautions----
Cordarone (amiodarone HCl) 200 mg tablets--Warnings-Adverse Reactions---
Flector Patch (diclofenac epolamine) 1.3% topical patch--Warnings-----
Kayexalate (sodium polystyrene sulfonate) powder--Warnings-----
Lexiva (fosamprenavir calcium) tablets and oral suspension--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Neoral (cyclosporine capsules, modified) soft gelatin capsule and oral solution--WarningsPrecautionsAdverse Reactions---
Ortho Evra (norelgestromin/ethinyl estradiol) transdermal system--Warnings-----
Pre-Pen (benzylpenicilloyl polylysine) injection--WarningsPrecautions----
Sustiva (efavirenz) capsules and tablets--WarningsPrecautions-Patient Package Insert--
Ultram (tramadol hydrochloride) tablets--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Voltaren Gel (diclofenac sodium) 1% topical gel--Warnings-----
Zolinza (vorinostat) capsules--WarningsPrecautions----
Accuretic (quinapril hydrochloride/ hydrochlorothiazide) tablets---Precautions----
Asacol (mesalamine) 400 mg delayed-release tablets---Precautions----
DepoDur (morphine sulfate extended-release) liposome injection---Precautions----
Doral (quazepam) 7.5 mg and 15 mg oral tablets---Precautions----
Lovaza (omega-3-acid ethyl esters) capsules---Precautions----
Lozol (indapamide) 1.25 and 2.5mg tablets---Precautions----
Malarone (atovaquone and proguanil hydrochloride) tablets---Precautions----
Maxipime (cefepime hydrochloride) 500 mg, 1g, 2g per vial powder for injection---Precautions----
Drug Name BW C W P AR PPI MG PCI
OxyContin (oxycodone hydrochloride) controlled-release tablets---Precautions----
Zantac (ranitidine hydrochloride)----Adverse Reactions---
Darvon (propoxyphene hydrochloride) capsules, Darvon-N (propoxyphene napsylate) tablets, and Darvocet-N (propoxyphene napsylate and acetaminophen) tablets--------
Prilosec OTC (omeprazole magnesium) 20 mg delayed-release tablets--------
Reglan (metoclopramide) tablets--------
Vaginal Ointment (300 mg, 6.5%, tioconazole) and 1-Day Ointment (300 mg, 6.5% tioconazole)--------
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