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 Tagged ‘Heparin recall’
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 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.
Despite recall, Baxter International enjoys third-quarter gains
Despite heparin-recall woes earlier in the year, Pharmaceutical drug giant Baxter International announced that it had a 19 percent increase in third-quarter profits, according to a Baxter International press release.
FDA to set up offices worldwide
The U.S. Food and Drug Administration (FDA) will place more than 60 food and drug regulators worldwide over the next year to provide guidance on U.S. quality standards, according to the Associated Press. This will replace the agency’s current practice of sending staffers on individual assignments to inspect foreign facilities.
Senator proposes country-of-origin labeling for medications
If Sen. Sherrod Brown (D-OH) has his way, we soon may be able to read the label of prescription medications and learn where they were manufactured. Sen. Brown recently introduced the Transparency in Drug Labeling Act (S. 3633), arguing that Americans have the right to know where their medications are produced, according to Pharmaceutical Technology.
Synthetic heparin expected to launch early 2009
Australia-based Alchemia, a biotechnology company specializing in synthesis and manipulation of carbohydrates, announced on its Web site that it is on target to launch its antithrombotic drug, generic fondaparinux. Generic fondaparinux targets the multi-billion dollar heparin drug market. The company claims fondaparinux has a superior safety and efficacy profile to the market-leading drug Lovenox. Meanwhile, the brand-name fondaparinux drug Arixtra, made by GlaxoSmithKline (GSK) continues to gain market share.
French Lovenox brand heparin recall
There has been yet another report of heparin being pulled off the market for fear it may harm people. This week, French drug maker Sanofi-Aventis recalled the remaining batches of its heparin medicine distributed before May 2008, Lovenox, based on a recommendation by French drug regulator Afssaps.
Candidates review reimportation of prescription drugs
Recent scares of tainted medicines and goods from foreign countries, such as contaminated batches of heparin from China, have spurred presidential nominees Sen. Barak Obama and Sen. John McCain to review their support for individuals to import cheaper drugs from other countries, Reuters/Boston Globe reported today.
APP ok to make heparin in Puerto Rico
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.