FDA MedWatch - September 2008 Drug Safety-Related Labeling Changes for 36 Drugs Now Available on Web

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Title: FDA MedWatch - September 2008 Drug Safety-Related Labeling Changes for 36 Drugs Now Available on Web
MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

The September 2008 posting includes 36 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.

The "Summary Page" provides a listing of drug names and safety labeling sections revised:

 http://www.fda.gov/medwatch/safety/2008/sep08_quickview.htm

The "Detailed View Page" identifies safety labeling sections and subsections revised along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:

http://www.fda.gov/medwatch/safety/2008/sep08.htm

In September 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:

Aceon (perindopril erbumine) Tablets

Proair HFA (albuterol sulfate) Inhalation Aerosol

EpiPen (epinephrine) Auto-Injector 0.3 mg & EpiPen JR (epinephrine) Auto-Injector 0.15 mg

Erbitux (cetuximab) Solution for Intravenous Use

Exubera (insulin human [rDNA origin]) Inhalation Powder

Gleevec (imatinib mesylate) Tablets

Heparin Sodium Injection, USP [Preservative Free]

Heparin Sodium Injection, USP [Preserved with Parabens]

Nasacort AQ (triamcinolone acetonide) Nasal Spray

Noroxin (norfloxacin) Tablets

Photofrin (porfimer sodium) Injection

Reyataz (atazanavir sulfate) Capsules

Rituxan (rituximab) Injection for Intravenous Use

Tarceva (erlotinib) Tablets

Uroxatral (alfuzosin HCl extended-release tablets)


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