› $4.85 Billion settlement in drug case
A recent report in Huliq News documents efforts by the U.S. Pharmacopeial (USP) Convention to improve the safety of blood thinner heparin by revising its written and physical standards for the drug. The update comes at the request of the U.S. Food & Drug Administration (FDA) following a 2008 public health crisis when more than 200 people died after being administered contaminated heparin.
The U.S. Food and Drug Administration (FDA) issued and FDA NEWS release today informing the public that it has removed 11 lots of heparin from Celsus Laboratories, Inc., in Cinncinnati, Ohio. According to the release, the FDA has determined five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were contaminated with over-sulfated chondroitin sulfate (ASCS). The heparin products were manufactured from material imported from China.
The FDA ordered U.S. Marshals to seize the products today. Mike Chappell, acting associate commissioner for regulatory affairs for the FDA is quoted as saying, “This action will help prevent this contaminated heparin from finding its way into the marketplace.”
Earlier this year, heparin manufactured by Baxter International, Inc., was found to be contaminated with OSCS. That heparin also contained components manufactured in China, which is believed to be the source of the contamination. The Baxter contamination led to hundreds of injuries and 81 deaths.
The FDA news release states that the agency has initiated 13 recalls of multiple contaminated medical products containing heparin from several companies, to date this year.
Information in the news release indicates the Celsus heparin entered the United States before the establishment of FDA import controls for the drug, and was reviewed by the FDA after it was processed at Celsus as a part of the agency’s process to implement the controls.
The release also indicates that the FDA knew about the contamination in April 2008, when it warned Celsus Laboratories during an inspection that the company’s actions to notify customers about the contaminant were insufficient. The FDA says it warned Celsus again that it needed to step up its efforts to notify customers about the potential hazard in a May 8, 2008 letter. Finally, today the FDA seized the contaminated product from the lab.
Manufacturers who may have purchased heparin from Celsus are urged to contact the company immediately to make sure they are not using any heparin from the since-seized lots. The product does not meet acceptable quality standards, the release says.
Recently, we reported about the development of synthetic heparin as a safer alternative to today’s heparin, which is manufactured from the intestines of animals. The work is a project of Robert Linhardt, a professor at Rensselaer Polytechnic Institute in Troy, New York. Recently, Linhardt presented information about his work on the synthetic heparin, as well as findings in a new project using heparin to create a “paper battery,” at the NanoBioTech forum.
The Associated Press reported today that German dialysis clinic operator Fresenius has been approved to purchase APP Pharmaceuticals. APP makes injectable drugs, including heparin, and just announced its plans to begin manufacturing heparin at its Puerto Rico facility after receiving approval by the U.S. Food & Drug Administration (FDA).
This week APP Pharmaceuticals, headquartered in Schaumberg, Ill., announced it has gotten FDA approval to manufacture heparin at its Barceloneta, Puerto Rico, facility. The facility will manufacture three product codes of heparin sodium injection, USP.
Robert Linhardt, a scientist at Troy, New York-based Rensselaer Polytechnic Institute, is leading a team of researchers who have developed a fully synthetic version of the blood thinner heparin. While the group has only produced a few milligrams of the substance, it is the first step in eliminating the risk of contamination currently associated with the drug, which is manufactured primarily from pig intestines.
Attorneys who take on the pharmaceutical industry as a voice for consumers injured by medications found an unlikely ally this week, in doctors. Noting that the U.S. Food & Drug Administration is often “overwhelmed” by drug safety problems ranging from serious side effects to unsafe manufacturing facilities, editors of the New England Journal of Medicine said patients benefit from information uncovered by attorneys during liability investigations, according to an Associated Press report released Friday.
