Contaminant confirmed in tainted heparin
By Gene Emery
BOSTON (Reuters) - The contaminant linked to dozens of deaths and hundreds of illnesses from tainted batches of the blood thinner heparin manufactured in China was chemically related to a dietary supplement used to treat joint pain, researchers confirmed on Wednesday.
The U.S. Food and Drug Administration announced in March that it believed the contaminant to be over-sulfated chondroitin sulfate or OSCS, a modified version of the joint supplement chondroitin sulfate.
Wednesday’s announcement was confirmation of that finding and means that new tests put in place to scan for OSCS contamination should be effective.
Maker Baxter International Inc. launched two recalls of its heparin products — used in heart surgery and kidney dialysis — on January 17 and February 28 after 113 patients in 13 states suffered adverse reactions such as low blood pressure, nausea and shortness of breath.
Ram Sasisekharan of the Massachusetts Institute of technology and colleagues at the Centers for Disease Control and Prevention found that more than 98 percent of the 152 reactions they studied were at health centers where the heparin was contaminated by OSCS.
“Of 54 reactions for which the lot number of administered heparin was known, 52 (96.3 percent) occurred after the administration of OSCS-contaminated heparin,” they wrote in the New England Journal of Medicine.
OSCS can thin blood, passes the quality control screening test used at the time and is far cheaper to acquire than getting real heparin from pig intestines.
Sasisekharan said in a telephone interview that the study made no attempt to determine how the heparin became contaminated, but the chondroitin was purified. “It is hard to explain a natural biological source for this,” he said.
In the samples his group examined, up to 35 percent of the heparin, by dry weight, was actually OSCS.
Sasisekharan said the contamination coincided with the spread of a virus that had created a shortage of pigs in China.
“There weren’t enough pigs around, you’re not able to get enough heparin, and the over-sulfated chondroitin passes the test that is in place to screen heparin,” he said.
A key unanswered question is whether patients who survived exposure to the tainted heparin still may have health problems.
“There were countries that were still using the contaminated heparin because of an acute shortage, so they took the risk,” said Sasisekharan. “We have no idea what the long-term exposure implications are.”
(Editing by Maggie Fox and Cynthia Osterman)
--------------------------------------------------------------------------------------------Related Posts:
WASHINGTON (Reuters) - U.S. regulators are asking drugmakers to submit more details about their supply chains under a pilot program announced on Wednesday to help protect patients from fake or tainted medicines from overseas. Companies that voluntarily provide the information can get the products through U.S. border entry points more quickly, Food and Drug Administration officials
Full Post: U.S. seeks details of supply chains for foreign drugs
--------------------------------------------------------------------------------------------
By Lucy Hornby BEIJING (Reuters) - U.S. officials opened the first overseas Food and Drug Administration office in Beijing on Wednesday as they gear up for a long battle to ensure the quality of food, drug and feed imports from China. The eight FDA workers in Beijing, Shanghai and Guangzhou will set up a process for pre-certifying
Full Post: U.S. says food, drug inspection access in China improving
--------------------------------------------------------------------------------------------
Hemarthrosis is characterized with bleeding associated to a joint cavity. A joint that exhibits hemarthrosis in frequent episodes, it is named a target joint. It means that the same joint needs to experience at least 4 bleeds separately in a span of 6 months. The joints that are mostly affected include ankles, elbows, and knees,
Full Post: Everything about Hemarthrosis
--------------------------------------------------------------------------------------------
NEW ORLEANS (Reuters) - A new blood test to identify heart failure patients in most dire need of treatment when they turn up at an emergency room complaining of shortness of breath proved better than current tests, according to results of a study unveiled on Tuesday. The pivotal trial of the test developed by privately held
Full Post: New test to identify heart failure in ER superior
--------------------------------------------------------------------------------------------
What is a dietary supplement? Diet supplements refer to those drugs that can provide one or more essential nutrients that are needed by the body. They may contain one or a set of vitamins and minerals such as iron, calcium, protein and others. Diet supplements can be made out of chemical processes or they can be
Full Post: How to Check the Quality of Your Diet Supplements