FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer

FOR IMMEDIATE RELEASE
November 6, 2008

Media Inquiries:
Karen Riley, 301-827-6244
Consumer Inquiries:
888-INFO-FDA

FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer

As part of the U.S. Food and Drug Administration’s ongoing efforts to ensure that heparin for patients remains safe, the government today seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio.

The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA’s request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin’s anticoagulant activity.

“This action will help prevent this contaminated heparin from finding its way into the marketplace,” said Mike Chappell, acting associate commissioner for regulatory affairs, FDA.

Heparin is a blood-thinning drug. An API is a substance or mixture of substances that, when delivered in a finished drug product, directly affects the structure or function of the body. Heparin Sodium USP is an API that may be incorporated into finished drug products. Heparin Lithium is used in certain medical devices including vacutainer blood collection tubes, some in vitro diagnostic assays, and as a coating for capillary tubes. Celsus has distributed Heparin Sodium USP and Heparin Lithium to manufacturers in both the United States and abroad.

OSCS contaminant in injectable drug products containing heparin has been linked to multiple adverse events and deaths initially reported to the FDA in January 2008. Since then, the FDA has put in place a comprehensive inspection and import controls program and has acted to remove from the market heparin materials and products contaminated with OSCS. The seized Celsus heparin – which had entered the United States before the establishment of import controls for the drug – was tested for the presence of OSCS as part of this FDA effort.

To date, the agency has initiated 13 recalls of multiple contaminated medical products containing heparin from several companies.

The FDA informed Celsus Laboratories during an April 2008 inspection and again in a May 8, 2008, letter that the company’s actions to notify customers about a contaminant in its heparin were insufficient to assure an effective recall. The agency advises manufacturers who may have purchased heparin from Celsus to contact the company to make certain they are not using any heparin from the seized lots because the product does not meet acceptable quality standards.

The FDA has notified Japanese, Canadian, Australian, European Union, and other international authorities of shipments of contaminated heparin from Celsus.


Uses/Indications – Heparin’s primary uses in small animal medicine include treatment of Disseminated Intravascular Coagulation (DIC), and treatment of thromboembolic disease. In horses, it has also been used in the treatment of DIC and as prophylactic therapy for laminitis (unproven efficacy).


Heparin Sodium For Veterinary Use
By Barbara Forney VMD

Overview

Therapeutic Class
Parenteral anticoagulant

Species
Dogs, cats and horses

Commonly prescribed by vets for:
Catheter maintenance, thrombo-embolic disease.

FDA Status
No veterinary approved products.

Basic Information

Heparin is a naturally occurring glycosaminoglycan that is found in mast cells. Most commercially available heparin is manufactured from porcine or bovine origin. Heparin’s mechanism of action is on both the extrinsic and intrinsic coagulation pathways. It does not significantly change the concentration of clotting factors, but rather blocks the clotting pathways. Heparin will not dissolve an existing clot. Heparin does not cross the placenta and is used with caution during pregnancy when the benefits of anticoagulation are felt to outweigh the risks. The FDA classifies it as a class C drug.
Heparin must be given either intravenously or subcutaneously. It is not absorbed orally and should not be given intra-muscularly due to hematoma formation. With the exception of IV catheter maintenance, most heparin use is in animals with serious medical problems and will require close supervision and hematologic monitoring.

Dogs and Cats, and Horses

Heparin is used in a variety of medical conditions where there is excessive clotting or increased risk of clot formation. These may include thromboembolic disease, pancreatitis, laminitis, endotoxic shock and burns. It is also commonly used for the maintenance of intravenous catheters. Heparin was commonly used in the treatment of disseminated intravascular coagulopathy, but that use is becoming controversial.

Side Effects

• Bleeding and thrombocytopenia

• Hypersensitivity reaction may occur due to the foreign protein.

• Numerous rare side effects include decreased kidney function, osteoporosis, vascular spasm, electrolyte abnormalities, hyperlipidemia.

Precautions

• Heparin should not be used in animals with severe thrombocytopenia, those that are actively bleeding, or have uncontrollable bleeding.

• There is wide variability in the response to heparin and a wide range of recommended doses. Regular monitoring of clotting function is important particularly during the early stages of treatment.

Drug Interactions

• Heparin should be used with caution when used with other drugs that affect coagulation such as NSAIDs, aspirin and wafarin.

• Heparin may reduce the effects of corticosteroids, insulin and ACTH.

• Antihistamines, nitroglycerin, digoxin and tetracycline may decrease the effects of heparin.

Overdose

• Heparin overdose is associated with bleeding. Before frank bleeding occurs, subtler symptoms may include bruising, petechiaie and blood in the urine or stool. Protamine is the drug of choice for heparin toxicity. Protamine will bind with heparin and neutralize the anti-thrombin effects within five minutes of intravenous injection.

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