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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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