Scientists develop heparin antagonist medication
Scientists in Poland are developing a new way to remove heparin from blood in order to reduce or avoid the occurrence of unwanted side effects, according to Science Centric.
News for November, 2008
Contaminated heparin removed from Cinnicinnati plant
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.
Heparin found to reduce septic shock death rate
Heparin may serve as a very inexpensive and effective new treatment for septic shock, according to Canada.com.
Septic shock is a serious condition that can cause multiple organ failure and death. It is the main cause of mortality in intensive care units (ICU), with a mortality rate of up to 40 percent.
Scientists work to overcome obstacles in synthetic heparin
Heparin remains in high demand in the United States, with more than 300,000 doses used daily. The blood thinner, which has been widely used since the 1930s, saves lives by preventing potentially fatal blood clots and reducing the amount of time patients with kidney failure stay on dialysis machines. However, controversy surrounds the medication and companies are quickly working on alternatives.
Heparin used in innovative cholesterol-separating method
People who have high cholesterol may have another alternative to statin drugs – a method that literally sucks bad cholesterol right out of a patient’s blood, according to the St. Louis Post-Dispatch.