Drug Safety Labeling Changes - September 2008

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September 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
Proair HFA (albuterol sulfate) Inhalation Aerosol-ContraindicationsWarningsPrecautionsAdverse Reactions---
EpiPen (epinephrine) Auto-Injector 0.3 mg--WarningsPrecautionsAdverse Reactions---
EpiPen JR (epinephrine) Auto-Injector 0.15 mg--WarningsPrecautionsAdverse Reactions---
Erbitux (cetuximab) Solution for Intravenous Use--WarningsPrecautionsAdverse Reactions---
Exubera (insulin human [rDNA origin]) Inhalation Powder--Warnings-----
Heparin Sodium Injection, USP [Preservative Free]--WarningsPrecautions----
Heparin Sodium Injection, USP [Preserved with Parabens]--WarningsPrecautions----
Nasacort AQ (triamcinolone acetonide) Nasal Spray--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Noroxin (norfloxacin) Tablets--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Photofrin (porfimer sodium) Injection--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Reyataz (atazanavir sulfate) Capsules--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Rituxan (rituximab) Injection for Intravenous Use--WarningsPrecautions----
Tarceva (erlotinib) Tablets--WarningsPrecautionsAdverse Reactions---
Uroxatral (alfuzosin HCl extended-release tablets)--Warnings-----
Capoten (captopril tablets, USP)---Precautions----
Celexa (citalopram hydrobromide) Tablets and Oral Solution ---Precautions----
Detrol (tolterodine tartrate tablets)---Precautions-Patient Package Insert--
Detrol LA (tolterodine tartrate extended release capsules)---Precautions-Patient Package Insert--
Glucovance (glyburide and metformin HCl tablets)---Precautions----
Invega (paliperidone) Extended-Release Tablets---Precautions----
Drug Name BW C W P AR PPI MG PCI
Lariam (mefloquine hydrochloride) Tablets---PrecautionsAdverse Reactions---
Stromectol (ivermectin) Tablets---Precautions----
Vaseretic (enalapril maleate and hydrochlorothiazide) Tablets---Precautions----
Ventavis (iloprost) Inhalation Solution---PrecautionsAdverse Reactions---
Videx EC (didanosine, USP) Delayed-Release Capsules (Enteric-Coated Beadlets)---Precautions-Patient Package Insert--
Alimta (pemetrexed disodium) Injection, Powder, Lyophilized, For Solution for Intravenous Use----Adverse ReactionsPatient Package Insert--
Curosurf (poractant alfa) Intratracheal Suspension----Adverse Reactions---
Lybrel (90 mcg levonorgestrel and 20 mcg ethinyl estradiol) Tablets----Adverse ReactionsPatient Package Insert--
NeoProfen (ibuprofen lysine) Injection----Adverse Reactions---
Retrovir (zidovudine) Tablets, Capsules, and Syrup----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Valtrex (valacyclovir hydrochloride) Caplets----Adverse ReactionsPatient Package Insert--
Pegasys (peginterferon alfa-2a)--------
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