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Medtronic, Inc. voluntarily recalled several Heparin products, According to the U.S. Food and Drug Administration (FDA). One can only wonder what took them so long to get this conviction. On April 8, 2008, the U.S. Food and Drug Administration's recommended that heparin supplies be checked with newly-developed tests, and that affected products be evaluated for possible field corrective action. The Medtronic recalled products include disposables used for heart surgeries and the cardiopulmonary bypass, including reservoirs, blood oxygenators, tubing packs, and pumps. It is unclear if exposure to Heparin Carmeda-coated medical devices could cause adverse events similar to those observed with injectable heparin formulations.

In a separate action, Medtronic is advising customers that selected lots of Trillium-coated products were also manufactured with heparin containing OSCS. Trillium is another biosurface used on CPB products. The ultimate goal is to remove all contaminated products from the market.

The Medtronic recall is a precautionary one. Let's all hope the company continues to take measures regarding their products that will help save lives and not threaten them.

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Concerned Citizens, Health Care Personnel, the FDA wants your opinion on the new FDA Proposed Guidance for Dissemination of Information on Unapproved Uses of Medical Products. Public Comments will be accepted for 60 days. 

"Articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care," said Randall Lutter, FDA deputy commissioner for policy. "This guidance also safeguards against off-label promotion."

Previously, Section 401 of the Food and Drug Administration Modernization Act set out guidelines that allowed the dissemination of information on unapproved uses of FDA-approved products. As long as the guidelines were met by the manufacturers, the dissemination of such materials was not viewed by the FDA as evidence of an intent to promote the product for an "off-label" use. However, Section 401 expired on Sept. 30, 2006.

Comments via the Internet:  go to Docket Number FDA-2008-D-0053 on the Regulations.gov Web site.

Comments via mail:
Submit comments to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

All comments should be identified with the docket number, FDA-2008-D-0053. For single copies of the draft guidance, call 301-827-3360 or contact: Office of Policy, Food and Drug Administration, 5600 Fishers Lane, Room 14-101, HF-11, Rockville, MD 20857.

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NATIONWIDE URGENT DEVICE RECALL - Heparin and Saline Flushes by AM2 PAT

The FDA has announced an urgent nationwide recall of pre-filled Heparin and normal Saline Flushes that were manufactured by AM2 PAT, Inc. of Angier, a North Carolina based Company. The pre-filled syringes are contaminated with Serratia marcescens, which has resulted in patient infections. The products can be found under the brand names, Sierra Pre-Filled Inc. and B. Braun. They 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 was found to be contaminated with Serratia marcescens, which has resulted in patient infections. The CDC  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 products were recalled after bacterial contamination in some end user samples of product code 1003-02, Lot 070926H was found.

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.

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.

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This week, The House of Representatives approved legislation that gives the FDA more power to police the safety of prescription drugs, sending the measure to the Senate for final approval.

What if the the Food and Drug Administration required drugmakers to study the safety of their products after they go on the market? Would that be so terrible? Would it be a bad thing for regulators to order warnings added to prescribing information? If these measures can help save lives and prevent more illnesses, I think not.

This new legislation may be able to prevent future repeats of what happened with Vioxx, the Merck & Co. painkiller, allegedly linked to heart attacks and strokes, and Avandia, GlaxoSmithKline Plc's diabetes pill linked in some studies to a risk of heart attacks.

I hope that  Representative Henry Waxman, a California Democrat, is correct in his assessment that the legislation ``provides FDA with critical tools the agency has been desperately lacking in its efforts to protect the American public from unsafe drugs". Now let's see if the Senate agrees.

Click here to read more on this new FDA legislation from Bloomberg News.

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The Executives at GlaxoSmithKline  must be breathing a huge sigh of relief. They only received a mere minor setback with the new Food and Drug Administration decision. Yesterday, The FDA  advisory panels called  for new warnings for the widely used diabetes drug Avandia. New evidence has shown that it significantly raises the risk of heart attack, however, they stopped short of recommending that the drug be pulled from the market, as some FDA officials had urged. I wonder why and how they managed to get a 22 to 1 vote to allow continued sales of  Avandia?

There has been controversy among regulators, drug company officials, physicians and advocates for patients, who have offered dueling interpretations of contradictory safety studies. Maybe it is because it is a "Billion Dollar Baby" for the North Carolina Drug Maker, GlaxoSmithKline. Last year, Avandia produced $3 billion in sales for the company. Today, stock for GlaxoSmithKline closed at $51.08, an increase of $1.64 per share. I think that shareholders must be happy with the news of the new FDA warning.

                                           
The company that produces Tums and other well known brands have been given another chance to make a difference in the lives of millions of people around the world. Let's hope that this miracle they received, will keep them in check and make them proactively share critical information to unsuspecting consumers before they take a GSK drug or product, instead of after the fact. Good corporate citizenship requires as much, if not more.Click Here to read more from the Washington Post on the Avandia FDA Warning.

The LaBovick Injury Law Blog is presented as a service of the Private Law Firm, LaBovick & LaBovick, P.A., Civil Justice Prosecutors. 

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