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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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 27 Feb 2008 08:48:02 -0600 (CST)
Subject: FDA Warning Letters Update

You are subscribed to FDA Warning Letters for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 27 Feb 2008 17:04:19 -0600 (CST)
Subject: FDA Approves New Orphan Drug for Treatment of Rare Inflammatory Syndromes

FDA Approves New Orphan Drug for Treatment of Rare Inflammatory Syndromes
Wed, 27 Feb 2008 15:57:00 -0600

The U.S. Food and Drug Administration today approved a drug to help ease the suffering faced by those with certain chronic inflammatory diseases. Arcalyst (rilonacept, an Interleukin-1 blocker) is now approved for the long term treatment of two Cryopyrin-Associated Periodic Syndromes (CAPS) disorders: Familial Cold Auto-Inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 27 Feb 2008 13:18:06 -0600 (CST)
Subject: FDA MedWatch - FDA MedWatch - Tysabri (natalizumab) - Reports Of Clinically Significant Liver Injury

Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients. Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury. Physicians should inform patients that Tysabri may cause liver injury.

Read the complete 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Professional Letter and prescribing information for Tysabri at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tysabri

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 26 Feb 2008 05:41:08 -0600 (CST)
Subject: CDRH New Update

	FDA Home Page | CDRH Home Page | Search | A-Z Index

Date: February 26, 2008

The following new items were added to the CDRH web pages on February 25, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	Advice for Patients: Denture Cleansers
	FDA Public Health Notification: Denture Cleanser Allergic Reactions and Misuse
	Questions and Answers on Chattem, Inc. Icy Hot Heat Therapy Air Activated Heat (Back and Arm, Neck & Leg)

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 26 Feb 2008 12:06:02 -0600 (CST)
Subject: Wang Globalnet Issues Allergy Alert on Undeclared Eggs, Peanuts and Milk Allergens in Lotte Margaret Brand Korean Cracker (Feb. 14)

Wang Globalnet Issues Allergy Alert on Undeclared Eggs, Peanuts and Milk Allergens in Lotte Margaret Brand Korean Cracker (Feb. 14)
Tue, 26 Feb 2008 10:31:00 -0600

Wang Globalnet is recalling 19 gram packages of Lotte Margaret Brand Korean Cracker because they may contain undeclared eggs, peanuts and milk allergens. Consumers who are allergic to eggs, peanuts and milk may run the risk of serious or life-threatening allergic reactions if they consume this product. The product comes in a 19 gram cardboard box marked with item#: 00438 on the top and a code date of 08.08.06.B2 stamped on the side. The recalled packages of Lotte Margaret Brand Korean Cracker were distributed nationwide in retail stores.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 26 Feb 2008 14:06:38 -0600 (CST)
Subject: Summit Import Corporation Issues an Alert on Uneviscerated Fish (Feb. 12)

Summit Import Corporation Issues an Alert on Uneviscerated Fish (Feb. 12)
Tue, 26 Feb 2008 12:48:00 -0600

Summit Import Corp. is recalling all packages of Sum Cheong Lung brand Dried Fish discovered by New York State Dept. of Agriculture and Markets Food Inspectors during a routine inspection and subsequent analysis of the product by Food Laboratory personnel confirming that the fish had not been eviscerated prior to processing. This product may be contaminated with Clostridium botulinum spores, which can cause Botulism, a serious and potentially fatal foodborne illness.

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Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 26 Feb 2008 11:03:17 -0600 (CST)
Subject: FDA MedWatch - Avandia (rosiglitazone maleate): new Medication Guide issued

FDA and GlaxoSmithKline notified pharmacists and physicians of a new Medication Guide for Avandia (rosiglitazone maleate). The FDA regulation 21CFR 208 requires a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern. A list of currently approved Medication Guides are available at http://www.fda.gov/cder/Offices/ODS/medication_guides.htm.

See the MedWatch 2008 safety summary, including links to the Medication Guide and the current Prescribing Information for Avandia, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Avandia

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Message: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 26 Feb 2008 11:07:31 -0600 (CST)
Subject: FDA MedWatch - Denture Cleanser Allergic Reactions and Misuse

FDA notified dental healthcare professionals and patients of the risk of serious allergic reactions in users of denture cleansers. These adverse events, including abdominal pain, vomiting, seizures, hypotension and difficulty breathing, have occurred both when the product has been used properly as well as from improper use. These events can occur soon after first use or after years of use. FDA believes that the ingredient responsible for these reactions is persulfate, a known allergen. Persulfates are used in most denture cleansers to help clean and bleach the dentures. FDA has provided specific recommendations for dental healthcare professionals and an 'Advice for Patients' document.

FDA is recommending that all manufacturers of denture cleansers modify their labeling to include warning information that the product contains persulfates and recommends improving the directions for use on their labeling in order to reduce misuse.

See the MedWatch 2008 safety summary, including links to the Public Health Notification and "Advice for Patients", at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Denture
 

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 25 Feb 2008 05:41:24 -0600 (CST)
Subject: CDRH New Update

	FDA Home Page | CDRH Home Page | Search | A-Z Index

Date: February 25, 2008

The following new items were added to the CDRH web pages on February 22, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 25 Feb 2008 08:27:40 -0600 (CST)
Subject: Public Health Notifications Update

You are subscribed to Public Health Notifications for U.S. Food & Drug Administration (FDA), Center for Devices and Radiological Health.

The FDA has posted a new Public Health Notification regarding Denture Cleanser Allergic Reactions and Misuse.  This Notification provides information about the potential for allergic reactions due to persulfates and stresses the importance of following the product directions for use.

This Notification and accompanying Advice for Patients is available by clicking here.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 25 Feb 2008 15:40:15 -0600 (CST)
Subject: Denture Cleanser Allergic Reactions and Misuse - Medical Device Safety Update

Healthcare providers should be aware of a new public health notification that recommends specific actions to prevent or minimize serious patient injuries and allergic reactions related to the use of denture cleansers.

You are subscribed to Medical Device Safety for U.S. Food & Drug Administration (FDA).

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 22 Feb 2008 07:03:50 -0600 (CST)
Subject: Allergy Alert on Undeclared Pecans in Mayfield Vanilla Classic Ice Cream (Feb. 21)

Allergy Alert on Undeclared Pecans in Mayfield Vanilla Classic Ice Cream (Feb. 21)
Fri, 22 Feb 2008 05:51:00 -0600

Mayfield Dairy Farms announced today that it is voluntarily recalling half-gallon rectangular paper cartons of Mayfield Vanilla Classic Ice Cream with a code date of 01-30-09 and a Universal Product Code (UPC) number of 75243 20144. The recall was initiated because the affected product contains pecans, which are not listed on the label. No other code dates or Mayfield Dairy Farms products are involved in this recall.

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 22 Feb 2008 09:04:39 -0600 (CST)
Subject: Lion Pavilion Issues Alert on Undeclared Sulfites in Grassplot Brand Dried Pachyrhizus (Feb. 15)

Lion Pavilion Issues Alert on Undeclared Sulfites in Grassplot Brand Dried Pachyrhizus (Feb. 15)
Fri, 22 Feb 2008 07:09:00 -0600

Lion Pavilion LTD. of Brooklyn, NY is recalling 8 ounce packages of Grassplot brand Dried Pachyrhizus because they contain undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product. The product comes in an uncoded 8 ounce, clear plastic package. The recalled packages of Grassplot brand Dried Pachyrhizus were distributed nationwide.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 22 Feb 2008 11:04:55 -0600 (CST)
Subject: FDA Announces Permanent Injunction against Food Companies, Executives

FDA Announces Permanent Injunction against Food Companies, Executives
Fri, 22 Feb 2008 09:34:00 -0600

The U.S. Food and Drug Administration today announced that Brownwood Acres Foods Inc., Cherry Capital Services Inc. (doing business as Flavonoid Sciences) and two of their top executives have signed a consent decree that effectively prohibits the companies and their executives from manufacturing and distributing any products with claims in the label or labeling to cure, treat, mitigate or prevent diseases.

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 21 Feb 2008 06:02:35 -0600 (CST)
Subject: CDRH New Update

	FDA Home Page | CDRH Home Page | Search | A-Z Index

Date: February 21, 2008

The following new items were added to the CDRH web pages on February 20, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	Federal Register: Draft Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices; Availability.
	PMA Final Decisions for January 2008

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 21 Feb 2008 13:05:13 -0600 (CST)
Subject: FDA Licenses New Hemophilia Treatment

FDA Licenses New Hemophilia Treatment
Thu, 21 Feb 2008 11:09:00 -0600

The new treatment, called Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free, is a genetically engineered version of factor VIII, a protein essential for the clotting of blood. Factor VIII, known as an anti-hemophilic factor, is missing or decreased in patients with hemophilia A.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 21 Feb 2008 13:05:15 -0600 (CST)
Subject: Pierre's Ice Cream Company Issues Allergy Alert on its Homestyle Brand of Dutch Chocolate Ice Cream for Undeclared Peanut Butter Cup Candies (Feb. 20)

Pierre's Ice Cream Company Issues Allergy Alert on its Homestyle Brand of Dutch Chocolate Ice Cream for Undeclared Peanut Butter Cup Candies (Feb. 20)
Thu, 21 Feb 2008 11:58:00 -0600

This ice cream was distributed in Ohio, Michigan, Western Pennsylvania, and Indiana and reached consumers through retail stores. The packaging does not reveal the presence of peanut butter candy or peanuts on the ingredient label. If consumers have a Dutch Chocolate 56 fl oz (purple package) with the code 07320 on the rim of the lid, they should discard the ice cream and send the lid of the empty container back to Pierre’s for a full refund.

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420