|
The October 2008 posting includes 61 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/oct08_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/oct08.htm
In October 2008, the following drugs had modifications to the BOXED WARNING and CONTRAINDICATIONS sections:
Avelox (moxifloxacin hydrochloride) Tablets and Avelox I.V. (moxifloxacin hydrochloride in sodium chloride injection)
Cipro I.V. (ciprofloxacin) for Intravenous Infusion
Cipro (ciprofloxacin hydrochloride) Tablets and Cipro (ciprofloxacin) Oral Suspension
Cipro XR (ciprofloxacin extended-release tablets)
Factive (gemifloxacin mesylate) Tablets
Levaquin (levofloxacin) Tablets and Oral Solution, Levaquin (levofloxacin) Injection, for Intravenous Use, and Levaquin (levofloxacin in 5% dextrose) Injection, for Intravenous Use
Ontak (denileukin difttox) Solution for Intravenous Use
Raptiva (efalizumab) for Injection, Subcutaneous
Regranex (becaplermin) Gel 0.01 %
Apidra (insulin glulisine [rDNA origin] injection) Solution for Injection
Norditropin Cartridges [somatropin (rDNA origin) injection] for Subcutaneous Use
Prevacid NapraPAC 500 (lansoprazole delayed-release 15 mg capsules and naproxen 500 mg tablets kit)
Prezista (darunavir) Tablets
Rozerem (ramelteon) Tablets
Soma Compound with Codeine (carisoprodol, aspirin, and codeine phosphate, USP) Tablets
Zomig (zolmitriptan) Nasal Spray
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
