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FDA MedWatch


03/24/2008 -  The December 2007 posting includes 43 drug products with safety labeling changes to the following sections:  BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and 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/2007/dec07_quickview.htm

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

http://www.fda.gov/medwatch/safety/2007/dec07.htm

In December 2007, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:

Carbatrol (carbamazepine) Extended-Release Capsules

Equetro (carbamazepine) Extended-Release Capsules

Omniscan (gadodiamide) Injection for Intravenous Use

Tegretol (carbamazepine) USP, Chewable Tablets and Oral Suspension

Tegretol-XR (carbamazepine extended-release tablets)

Ambien CR (zolpidem tartrate extended-release) Tablets

AndroGel (testosterone gel) 1%

Dostinex (cabergoline) Tablets

Aredia (pamidronate disodium for injection)

Biaxin Filmtab (clarithromycin tablets, USP)

Biaxin XL Filmtab (clarithromycin extended-release tablets)

Biaxin Granules (clarithromycin for oral suspension, USP)

DepoDur (morphine sulfate extended-release liposome injection)

Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil 0.01% (Body Oil)

Doryx (doxycycline hyclate) Capsule, Delayed Release Pellets

Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules

Exjade (deferasirox) Tablets for Oral Suspension

Heparin Sodium Injection, USP

Heparin Sodium Injection, USP (porcine) 5,000 U/mL

Hepsera (adefovir dipivoxil) Tablets

Invega (paliperidone) Extended-Release Tablets

Levaquin (levofloxacin) Tablets and Oral Solution

Levaquin (levofloxacin) Injection, for Intravenous Use

Levaquin (levofloxacin in 5% dextrose) Injection, for Intravenous Use

Monodox (doxycycline monohydrate) Capsules

Sonata (zaleplon) Capsules
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