Proton Pump Inhibitors (PPI): Class Labeling Change1

• Proton Pump Inhibitors (PPI): Class Labeling Change¹ 
  Possible increased risk of fractures of the hip, wrist, and spine. Posted 05/25/201

Audience: Family Practice, consumers
[Posted 05/25/2010] FDA notified healthcare professionals and patients of revisions to the prescription and over-the-counter [OTC] labels for proton pump inhibitors, which work by reducing the amount of acid in the stomach, to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.
The new safety information is based on FDA's review of several epidemiological studies that found those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group. While the greatest increased risk for fractures in these studies involved people who had been taking prescription proton pump inhibitors for at least one year or who had been taking high doses of the prescription medications (not available over-the-counter), as a precaution, the "Drug Facts" label on the OTC proton pump inhibitors (indicated for 14 days of continuous use) also is being revised to include information about this risk. FDA recommends healthcare professionals, when prescribing proton pump inhibitors, should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition.
The safety communication includes a data summary with a table and references which support the epidemiological studies reviewed for this communication.
[05/25/2010 - Drug Safety Communication¹ - FDA]
[05/25/2010 - Possible Increased Risk of Bone Fractures With Certain Antacid Drugs² - FDA Consumer Health Update]
    

Vita Breath Dietary Supplement, Do Not Consume, FDA Advisory

Vita Breath Dietary Supplement, Do Not Consume, FDA Advisory
Audience: Consumers, healthcare professionals
[Posted 05/03/2010] FDA notified healthcare professionals, their patients, and consumers not to consume Vita Breath, a dietary supplement manufactured by American Herbal Lab and marketed at health fairs and on the Internet, because the product may contain hazardous levels of lead. The New York City Department of Health and Mental Hygiene analyzed a sample of Vita Breath and reported it contained 1,100 parts per million of lead. This level is more than 10,000 times higher than FDA’s maximum recommended level for lead in candy.
People with high blood levels of lead may show no symptoms, but the condition may cause damage to the nervous system and internal organs. Acute lead poisoning may cause a wide range of symptoms, including abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Children are particularly vulnerable to lead poisoning.
The FDA is working with state officials in New York and California to further investigate Vita Breath. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Online: www.fda.gov/MedWatch/report.htm¹
• Phone: 1-800-332-1088
• Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms²" page, to address on the pre-addressed form
• Fax: 1-800-FDA-0178

[05/01/2010 - News Release³ - FDA]

B. Braun Medical Inc. Recalls All Lots and All Sizes of Pre-Filled Heparin and Normal Saline Flush Syringes

B. Braun's Supplier Prompts Voluntary Recall of All Lots and All Sizes of Pre-Filled Heparin and Normal Saline Flush Syringes
AM2PAT Inc. manufactures these pre-filled syringes under both its private label, Sierra Pre-Filled Inc., as well as under the B. Braun Medical Inc. label

Contact:
Stephanie Euler, 908-276-4344 ext. 213
Susan Denby, 610-997-4856

FOR IMMEDIATE RELEASE -- January 18, 2008 -- B. Braun Medical Inc. was recently notified by its contract manufacturer, AM2PAT Inc., of a nationwide recall of all lots and sizes of Pre-filled Heparin and Saline Flush Syringes.

Catalog #	Lot #	Description
513584	All	Normal Saline 3mL in 12 mL Syringe
513586	All	Normal Saline 5mL in 12 mL Syringe
513587	All	Normal Saline 10mL in 12 mL Syringe
513610	All	10 units/mL Heparin, 5mL in 12 mL Syringe
513611	All	100 units/mL Heparin, 3mL in 12 mL Syringe
513612	All	100 units/mL Heparin, 5mL in 12 mL Syringe

Customers that have the recalled product in their possession should discontinue use immediately. If patients report any problems that may be related to usage of this product a physician should be contacted. Customers may contact the B. Braun Medical Inc. Customer Support Department at (800) 227-2862, Monday through Friday, 8 AM to 7 PM EST for instructions for handling the affected product and to arrange for replacement product.

Based on ongoing FDA inspection of AM2PAT Inc.'s facility, and CDC investigation it has been determined that there is a potential for the sterility of these affected products to be compromised, which may result in potential contamination. AM2PAT previously initiated a recall of one lot of Sierra Pre-Filled Heparin (lot #070926H) that was found to be contaminated with Serratia marcescens, which may lead to patient infections. CDC has confirmed growth of Serratia marcescens from several unopened syringes of this product in this specific AM2PAT lot. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 1-800-FDA-0178

tag: FDA, FDA Medwatch, B. Braun Medical recall, FDA Recall, Pre-Filled Heparin Recall, pre-filled Saline Flushes Recall, Heparin IV flush syringe Recall, Serratia marcescens,

AM2 PAT, Inc. Issues Nationwide Recall of All Lots and All Sizes of Pre-Filled Heparin and Normal Saline Flushes

NATIONWIDE URGENT DEVICE RECALL
RECALL EXPANSION 2nd Notice

FOR IMMEDIATE RELEASE DATE 01/18/08

AM2PAT, INC. (doing business as Sierra Pre-Filled Inc)
455 W. DEPOT STREET
ANGIER, NC 27501
919-552-9689

AM2 PAT, Inc. Issues Nationwide Recall of All Lots and All Sizes of Pre-Filled Heparin and Normal Saline Flushes

AM2 PAT, Inc., Angier, North Carolina, is initiating a Nationwide recall of all lots of both Heparin and Saline pre-filled flushes manufactured by AM2 PAT. These products are distributed under two brand names, Sierra Pre-Filled Inc. and B. Braun. These products are sold in 3ml, 5ml sizes for Heparin and 3ml, 5ml and 10ml sizes for Normal Saline. Both products are sold as pre-filled syringes.

One lot under recall of this product 1003-02, Lot 070926H, Heparin IV flush syringes has been found to be contaminated with Serratia marcescens, which has resulted in patient infections. CDC has confirmed growth of Serratia marcescens from several unopened syringes of this product.

This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.

Consumers and user facilities who have any of these recalled pre-filled syringes, Heparin or Saline Lock Flush Solution USP, should stop using the product immediately. These products should be immediately quarantined in your inventory and returned to your distributor immediately.

The following information for this recall includes:

MANUFACTURER: Sierra Pre-Filled, Inc., Angier, North Carolina

PRODUCT DESCRIPTION: Heparin Lock Flush Solution USP, All Strengths and Sizes

Saline Lock Flush Solution USP, All Strengths and Sizes

LOT #	NDC #	CATALOG #	Product Brand Name
All	64054-1003-02	1003-02	Heparin Lock Flush 100units/ml 5ml
	64054-1003-01	1003-01	Heparin Lock Flush 100units/ml 3ml
	64054-3005-02	3005-02	Heparin Lock Flush 10units/ml 5ml
	64054-3003-02	3003-02	Heparin Lock Flush 10units/ml 3ml
	64054-3003-06	3003-06	Heparin Lock Flush 10units/mL 3ml (6ml syringe)
	64054-3005-06	3005-06	Heparin Lock Flush 10units/mL 5ml (6ml syringe)
	64054-0910-2	0910-12	Normal Saline Flush 10ml
	64054-0905-2	0905-12	Normal Saline Flush 5ml
	64054-0903-2	0903-12	Normal Saline Flush 3ml

The firm voluntarily recalled these products after confirming bacterial contamination in some end user samples of product code 1003-02, Lot 070926H.

These products have been distributed nationwide.

It appears from an ongoing Food and Drug Administration (FDA) inspection of AM2 PAT, Inc.’s facility that the firm is not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes.

Consumers with questions may contact Sierra Pre-Filled at 919-552-9689, Monday through Friday, 10am-5pm Eastern Standard Time.

This recall is being conducted with the knowledge of the Food and Drug Administration.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

tag: Sierra Pre-Filled Inc recall, FDA, FDA Medwatch, CDC, AM2PAT recall, Pre-Filled Heparin Recall, pre-filled Saline Flushes Recall, Heparin IV flush syringe Recall, Serratia marcescens,