U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 28 Feb 2008 06:03:32 -0600 (CST)
Subject: FDA Approves Nexium for Use in Children Ages 1-11 Years

FDA Approves Nexium for Use in Children Ages 1-11 Years
Thu, 28 Feb 2008 04:47:00 -0600

The U.S. Food and Drug Administration approved Nexium (esomeprazole magnesium) for short-term use in children ages 1-11 years for the treatment of gastroesophageal reflux disease (GERD). The agency approved Nexium in two forms, a delayed-release capsule and liquid form. Nexium is approved in 10 milligrams (mg) or 20 mg daily for children 1-11 years old compared to 20 mg or 40 mg recommended for pediatric patients 12 to 17 years of age.

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 28 Feb 2008 16:05:53 -0600 (CST)
Subject: Walker's Food Products Company Recalls Four Bean Salad Because Of Possible Health Risk (Feb. 28)

Walker's Food Products Company Recalls Four Bean Salad Because Of Possible Health Risk (Feb. 28)
Thu, 28 Feb 2008 09:58:00 -0600

Walker's Food Products Company of North Kansas, Missouri, is recalling its 16oz., 5-lb. and 10-lb. containers of Four Bean Salad because of potential contamination with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product, even if it does not look or smell spoiled.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 28 Feb 2008 19:04:42 -0600 (CST)
Subject: Baxter to Proceed with Recall of Remaining Heparin Sodium Vial Products (Feb. 28)

Baxter to Proceed with Recall of Remaining Heparin Sodium Vial Products (Feb. 28)
Thu, 28 Feb 2008 17:10:00 -0600

Baxter International Inc. announced today that the company is proceeding with the voluntary recall of all remaining lots and doses of its heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products.

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Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 28 Feb 2008 13:07:48 -0600 (CST)
Subject: FDA MedWatch - November 2007 Monthly Safety Labeling Changes Posted on MedWatch Website

The November 2007 posting includes 39 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/nov07_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/nov07.htm

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

Abilify (aripiprazole) Tablets, Abilify Discmelt (aripiprazole) Orally Disintegrating Tablets, Abilify (aripiprazole) Oral Solution, Abilify (aripiprazole) Injection For Intramuscular Use Only

Aranesp (darbepoetin alfa) For Injection

Avandia (rosiglitazone maleate) Tablets

Epogen (epoetin alfa) For Injection

Myfortic (mycophenolic acid) Delayed-Release Tablets

Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

Sarafem (fluoxetine hydrochloride tablets)

Crestor (rosuvastatin calcium) Tablets

Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules

Kaletra (Iopinavir/ritonavir) Tablets and Solution

Lac-Hydrin (ammonium lactate) Lotion, 12%

Zometa (zoledronic acid) Injection - Concentrate for Intravenous Infusion

Arava (leflunomide) Tablets

Avalide (irbesartan-hydrochlorothiazide) Tablets

Celebrex (celecoxib capsules)

Eligard (leuprolide acetate for injectable suspension)

Invanz (ertapenem for injection)

Motrin IB (200 mg ibuprofen) Tablets

Nexavar (sorafenib) Tablets

Sprycel (dasatinib) Tablet For Oral Use

Toradol (ketorolac tromethamine tablets)

Vectibix (panitumumab) For Intravenous Use Only

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Message: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 28 Feb 2008 19:10:43 -0600 (CST)
Subject: FDA MedWatch - Heparin Sodium Injection: Recall of Multi-dose And Single-dose Vials

UPDATE - Baxter Healthcare and FDA informed healthcare professionals of a voluntary recall of all Heparin multi-dose and single-use vials, and Heparin lock flush solutions.

Read the MedWatch 2008 safety summary, including links to the Public Health Update, press release, and the previous safety alert information, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeparinInj2

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