FDA seizes Heparin from Cincinnati manufacturer
Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc., U.S., announced today that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) recommended that the FDA approve febuxostat for the treatment of hyperuricemia in patients with gout. The vote was 12 to zero in favor of
Full Post: Febuxostat recommended by panel for treatment of hyperuricemia in patients with gout
As part of the U.S. Food and Drug Administration’s ongoing efforts to ensure that heparin for patients remains safe, the government 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.
The blood-thinning drug heparin is highly effective when used to prevent and treat blood clots in veins, arteries and lungs, but earlier this year its reputation as a lifesaver was sullied when contaminated heparin products caused serious allergic reactions that led to a large number of deaths. Now, University of Michigan researchers have demonstrated a
Full Post: Simple, inexpensive method for detecting contaminants in heparin
A food scare in Britain involving pork from Ireland has forced all major supermarkets to remove all Irish pork products from their shelves because of concerns they may contain toxic dioxins. Britain’s Food Standards Agency (FSA) says tests on pork sourced from the Irish Republic or Northern Ireland have revealed the possible contamination with potentially
Full Post: Dioxins in Irish pork causes food scare in Britain
Scientists at the University of North Carolina at Chapel Hill have learned to customize a key human enzyme responsible for producing heparin, opening the door to a more effective synthetic anticoagulant as well as treatments for other conditions. Jian Liu, Ph.D., and colleagues at the UNC Eshelman School of Pharmacy have learned to modify the
Full Post: Scientists create synthetic Heparin in more varieties
Sun Pharmaceutical Industries Ltd. has announced that its fully owned US subsidiary, Sun Pharmaceutical Industries, Inc., has acquired 100% ownership of Chattem Chemicals, Inc. (Chattem) from Elcat, Inc,. The terms of the transaction were not disclosed. The Company will apply to regulatory authorities for appropriate clearances, as required. Chattem is registered with the US Drug
Full Post: Sun Pharma acquires Chattem Chemicals, Inc
From a quantitative standpoint, mineral oil is probably the largest contaminant of our body. That this contaminant can be tolerated without health concerns in humans has not been proven convincingly. The current Editorial of the European Journal of Lipid Science and Technology reflects on this and concludes that this proof either has to be
Full Post: Health problems associated with mineral oil contamination