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A team of researchers has confirmed that a contaminant found in several batches of the blood-thinner heparin is linked with severe allergic reactions in patients, dozens of whom died after receiving the tainted drug. A study conducted by the researchers provides epidemiological evidence that contaminated batches of heparin produced in China sickened hundreds of people, said MIT Professor Ram Sasisekharan. Sasisekharan is the senior author of the study, which appears in the Dec. 3 online edition of the New England Journal of Medicine. The tainted heparin scandal is among several recent contamination incidents involving products from China. It unfolded between...

Top image depicts the chemical structure of chondroitin sulfate, the contaminant found in batches of heparin. Bottom image shows the chemical structure of normal heparin. Graphic courtesy / Ishan Capila, Momenta Pharmaceuticals Click here to enlarge image (PhysOrg.com) -- A team of researchers has confirmed that a contaminant found in several batches of the blood-thinner heparin is linked with severe allergic reactions in patients, dozens of whom died after receiving the tainted drug. A study conducted by the researchers provides epidemiological evidence that contaminated batches of heparin produced in China sickened hundreds of people, said MIT Professor Ram Sasisekharan....

Federal drug regulators have seized batches of the tainted blood thinner heparin from a Cincinnati manufacturer that used a Chinese-made ingredient linked to 81 U.S. deaths earlier this year. The Food and Drug Administration (FDA) said yesterday that it took 11 lots of heparin from Celsus Laboratories that was contaminated with over-sulfated chondroitin sulfate (OSCS), a chemical used only to make fake blood thinner. The ingredient mimics heparin's anti-clotting properties but can cause severe allergic reactions and dangerously low blood pressure, according to reports the agency received beginning in January. No patients were harmed by the tainted Celsus products, which...

As health inspectors probe nearly 100 deaths tied to contaminated heparin, researchers develop safer version in the lab Blood thinners made from the complex carbohydrate heparin have been routinely used in the U.S. since the 1930s to keep veins, arteries and lungs clear of potentially fatal clots and to reduce the amount of time that kidney failure patients spend on dialysis machines. These drugs are so popular that there is not enough heparin—the active pharmaceutical ingredient (primarily derived from pig intestines) that enables these blood thinners to stop or prevent blood from clotting during medical procedures and treatments—to meet the...

Infant seriously ill before blood thinner error One newborn is dead after a Christus Spohn Hospital South pharmacy error that led to as many as 17 babies getting as much as 100 times the recommended dosage of the blood thinner heparin. It's still unclear what role, if any, the heparin played in the infant's death, because the child already was seriously ill and being cared for in the neonatal intensive care unit before dying Tuesday morning, said Dr. Richard Davis, chief medical officer for Christus Spohn Health System. Heparin routinely is used in the hospital's neonatal intensive care unit to...

The chief of US drug maker Baxter International says that its Chinese-made blood thinner heparin, which has been linked to dozens of deaths, appears to have been deliberately contaminated."We are greatly concerned that our heparin products appears to be the target of a deliberate adulteration scheme," Baxter chief executive Robert Parkinson said in prepared remarks to a US Congress panel. ...Mr Parkinson said it was clear the contaminant, an altered form of chondroitin sulfate, was added before crude heparin material reached Baxter's supplier in China, Scientific Protein Laboratories LLC (SPL). SPL, in separate testimony, also said the contamination appeared to...

SAN FRANCISCO (MarketWatch) -- Robert Parkinson, the chairman and chief executive of Baxter International Inc told a Congressional committee Tuesday its blood thinner heparin appears to have been deliberately contaminated, according to media reports.

A contaminant found in tainted heparin, the blood-thinner drug that has been linked to dozens of deaths, can trigger severe adverse reactions all by itself, researchers report. In one study released today, researchers confirm the presence of the chemical, known as oversulphated chondroitin sulphate, in suspect batches of heparin1. Another study found that the compound seems to trigger in pigs the same symptoms that have been seen in patients treated with the contaminated drug2. Contaminated heparin produces similar adverse reactions in swine.ANTONIA REEVE / SCIENCE PHOTO LIBRARY “We show that the contaminated heparin activates two inflammatory pathways, causing severe allergic...

April 24, 2008, 0:00 a.m. The High Cost of Cheaper DrugsThe heparin scare is a monitory lesson on drug importation. By Roger Bate Tainted heparin in 11 countries has caused the deaths of 81 patients, highlighting the potential danger of cheaply produced — sometimes counterfeit — imported medicines. Congress is holding multiple hearings on the tragedy, but it’s unlikely that they’ll draw the appropriate conclusion. All three presidential candidates support making drug importation easier to combat the “high cost of health care.� But they seldom acknowledge the inherent risk — and associated external costs — in such importation. According to...

An international team of researchers led by MIT has explained how contaminated batches of the blood-thinner heparin were able to slip past traditional safety screens and kill dozens of patients recently in the United States and Germany. The team, led by Professor Ram Sasisekharan of MIT, identified the chemical structure of the contaminant, known as oversulfated chondroitin sulfate (OSCS). The researchers present their findings and offer new approaches to detecting the contaminant in a report appearing April 23 in the online edition of Nature Biotechnology. Another team led by Sasisekharan has shown exactly how OSCS can kill-specifically by setting off...

WASHINGTON — A contaminated blood thinner from China has been found in drug supplies in 11 countries, and federal officials said Monday they had discovered a clear link between the contaminant and severe reactions now associated with 81 deaths in the United States. But a Chinese official disputed the assertion that the contaminant found in the drug, heparin, caused any deaths and insisted that his country’s inspectors be allowed to inspect the American plant where the finished heparin vials were made. He said any future agreement to allow American inspections of Chinese firms should be reciprocal. “We don’t have a...

WASHINGTON (Reuters) - U.S. Food and Drug Administration officials warned Baxter International Inc's supplier of the blood thinner heparin for failing to ensure that its manufacturing process can remove impurities, according to a letter released on Monday.

When cold medicine containing a poison made in China killed nearly 120 Panamanians in 2006 and early 2007, Americans could take some comfort in the belief that a similar epidemic could never happen here, not with one of the best drug regulatory systems in the world. Then last spring, hundreds if not thousands of pets died or were sickened in the United States by a Chinese pet food ingredient that contained lethal levels of melamine, an industrial product used to artificially boost protein levels. That was followed quickly by the discovery that Americans were brushing their teeth with Chinese toothpaste...

(CHANGZHOU, China) -- On a dusty lane in east China, a small factory sitting amid strawberry and vegetable fields processes chemicals from pig guts into heparin, a commonly used blood thinner linked to 62 deaths and hundreds of allergic reactions in the U.S. and Germany. The mysterious problems with heparin from the factory and others like it ? China's deadliest product quality scandal since Chinese cough syrup killed 93 people in Central America a year ago ? dramatically illustrate the perils of shifting drug production offshore. With recalls of heparin products now in six countries, it is an issue that...

(WASHINGTON) -- Expanding the scope of its Heparin recall, the government is sending letters to 82 medical device makers today warning them to withdraw any stents, catheters and other products that might contain the contaminated blood thinner. The move came as the Food and Drug Administration tripled the number of deaths that it said could be linked to the tainted drug. After reviewing more than 1,200 reports of allergic reactions from users, the agency said that 62 deaths since January 2007 may now be related to contaminated Heparin, up from the 19 deaths it previously counted during that period. In...

62 deaths linked to contaminated batches of the blood thinner, agency says WASHINGTON - The Food and Drug Administration on Tuesday said more than 100 patients have died while taking the blood thinner heparin since early 2007. The agency found that 62 deaths are associated with contaminated batches of the blood thinner, triple the previous estimate. That doesn't mean people are still dying — the latest deaths the FDA knows of occurred in February, the month Baxter International recalled contaminated batches. But dozens of deaths weren't reported to the agency when they happened, only later after the tainted blood thinner...

(SHANGHAI) — China’s top drug safety agency has ordered its local bureaus to increase supervision over the production of heparin, a blood-thinning drug that has been linked to at least 19 deaths and hundreds of allergic reactions in the United States, China’s state-run news agency reported Friday. The drug agency, the State Food and Drug Administration, said producers of the active ingredient in heparin must now obtain their raw material from registered suppliers, and it ordered the suppliers to strengthen their checks on the quality and safety of those raw ingredients. The announcement, just hours after American officials said they...

(WASHINGTON) — A manufacturer of the blood thinner heparin initiated a nationwide recall Friday because some products may contain a potentially dangerous contaminant. Contaminated heparin from a different manufacturer has been associated with 19 deaths and hundreds of allergic reactions. In the recall announced Friday, B. Braun Medical Inc. said it was recalling 23 lots of heparin as a precautionary measure. No adverse events have been reported in connection with their product, company officials said in a press release. The company issued the recall after one of its suppliers, Wisconsin-based Scientific Protein Laboratories, disclosed that an ingredient it provided contained...

AP Science Writer U.S. health officials have identified a contaminant in batches of the blood thinner heparin associated with 19 deaths and are trying to determine how the chemical got into the drug. The lots of heparin, whose key ingredient was imported from China, were recalled Feb. 28, and Food and Drug Administration officials said Wednesday that no new deaths have been reported since that time. Dr. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, said the contaminant is oversulfated condroitin sulfate, a chemical that does not occur naturally. Condroitin sulfate is a natural compound that...

The U.S. Food and Drug Administration has been widening its investigation into the hundreds of adverse reactions _ including difficulty breathing, nausea and falling blood pressure _ linked to U.S. health care company Baxter International's heparin injections. Heparin is derived from pig intestines, and China is the world's leading supplier. U.S. and Chinese officials have been investigating heparin samples but have reached no conclusions, Wu Zhen, the deputy commissioner of China's State Food and Drug Administration, said Sunday. The U.S. FDA found a contaminant in 20 of 28 samples of raw heparin from Baxter's main supplier, Scientific Protein Laboratories of...

The contaminant found in the blood-thinner heparin, which has been linked to hundreds of allergic reactions and possibly 19 deaths in the United States, has been traced to a Chinese plant that processed raw ingredients for the drug, U.S. health officials said Friday. As a result, the U.S. Food and Drug Administration said it will start testing all heparin products to be imported into the United States. The announcement comes as the agency continues its investigation into the contamination with heparin produced by Baxter Healthcare Corp., of Deerfield, Ill. The heparin was supplied to Baxter by Scientific Protein Laboratories of...

(WASHINGTON) -- A recalled blood thinner made with active ingredients from China appears to have been contaminated by a mysterious look-alike substance, now the focus of an investigation into as many as 19 U.S. deaths and nearly 800 serious drug reactions, federal officials said Wednesday. The drug -- heparin -- is a generic medication given to prevent blood clots. The manufacturer, Illinois-based Baxter Healthcare Corp., issued recalls last month after it noticed an unusual increase in reports of severe side effects. The Food and Drug Administration's findings raised questions about whether the medication was deliberately contaminated or whether some problem...

(FRANKFURT) — The German authorities said Friday that they had asked all German producers of the blood thinner heparin to check whether their ingredients came from China, after allergic reactions to the drug there were linked to two Chinese suppliers. In cases where China did supply the raw ingredient, manufacturers were asked to test for any irregularities. The German authorities recalled the suspect heparin on Wednesday after receiving reports of allergic reactions in about 80 patients. Heparin manufactured with Chinese ingredients has been linked to 19 deaths in the United States. Federal drug regulators there said sophisticated tests had found...

March 6, 2008 Drug Tied to China Had Contaminant, F.D.A. Says By GARDINER HARRIS and WALT BOGDANICH WASHINGTON — Federal drug regulators said Wednesday that a critical blood thinner that had been linked to at least 19 deaths and whose raw components were produced in China contained a possibly counterfeit ingredient that mimicked the real drug. Routine tests failed to distinguish the contaminant from the drug, heparin. Only sophisticated magnetic resonance imaging tests uncovered that as much as 20 percent of the product’s active ingredient was a heparin mimic blended in with the real thing. Federal officials said they did...

(YUANLOU, China) -- In a small, damp factory here, blood-smeared men wring pulp from pig intestines, then heat it in concrete vats. The activity at Yuan Intestine & Casing Factory is the first step in the poorly regulated process of making raw heparin, the main ingredient in a type of blood-thinning medicine that in recent days has come under suspicion in the deaths of four Americans. More than half the world's heparin comes from China. The chemical is often extracted from pig entrails in small factories -- many as rudimentary as this one, which also manufactures sausage casings from intestines....

The Chinese facility that supplies the active ingredient of the widely used blood thinner heparin was never inspected by the Food and Drug Administration because the agency confused its name with another just like it, agency officials said yesterday. The FDA said that a team of inspectors is headed now to China to inspect the plant as part of an effort to determine what may have caused a sudden spike in serious problems with the drug, which has been on the market since the 1930s. More than 350 adverse reactions to the drug have been reported to the FDA since...

WASHINGTON - U.S. health officials evaluated the wrong factory when assessing the safety of a Chinese-made drug ingredient that may be a source of problems with a blood thinner, the Food and Drug Administration said Monday. ADVERTISEMENT Baxter International's heparin has been linked to four deaths and hundreds of reports of allergic reactions. An investigation will take FDA inspectors to China this week. The Chinese manufacturer was not inspected because it was confused with another company in the agency's database with a similar name, said Joseph Famulare, deputy director of the Center for Drug Evaluation and Research's compliance department. The...

FDA never inspected China maker of Baxter's heparin Wed Feb 13, 7:38 PM ET U.S. regulators have never inspected the Chinese plant that makes Baxter International's heparin, regulators disclosed a day after Baxter halted sales of some versions after four patients died and hundreds became ill. "Preparations are being made to perform an inspection as soon as possible," Food and Drug Administration spokeswoman Karen Riley said in an email. On Tuesday, the Food and Drug Administration reported that it received about 350 reports of health problems associated with Baxter's injectable heparin, a blood thinner, since the end of 2007. Baxter,...

A Chinese facility that hasn't been inspected by the U.S. Food and Drug Administration made the active ingredient in much of the widely used Baxter International Inc. blood-thinner that is under investigation after reports of hundreds of allergic reactions and four deaths among the drug's users, the agency said yesterday. The disclosure is likely to add to broad concerns about the safety and quality of products imported from China and elsewhere in the developing world. A tide of tainted goods ranging from pet food to children's toys has prompted recalls and increased scrutiny of Chinese-made wares around the world. Although...

The blood thinner drug Heparin has been put on hold by Baxter, as the multiple-dose vials were found to cause severe reactions in patients. Patients were seen having severe reactions to the drug Heparin which include vomiting, dropping blood pressure to the point where they can go into shock, and more. The FDA stated that they were going to review Heparin further. There have been four reported deaths from Heparin in the multi-dose vials thus far. The FDA stated that the only issues came with the high dose vials of Heparin. The lower dose Heparin patients did not see nearly...

Actor Dennis Quaid's newborn twins have been admitted to a Los Angeles hospital's intensive care unit after they were accidentally given a drug overdose. Quaid and his wife, Kimberly, welcomed Thomas Boone Quaid and Zoe Grace Quaid into the world on November 8, but the babies are now fighting for their lives at Cedars-Sinai Medical Center.

Associated Press CHICAGO — Heart-attack patients are often given overdoses of powerful blood-thinning drugs in the emergency room, increasing their risk of serious bleeding, a study found. Of 30,136 heart-attack patients who were treated last year at 387 U.S. hospitals, 42 percent got excessive doses of blood thinners. Overdoses were particularly common in thin people, women, the elderly and people with kidney problems. Those given too much of two newer blood thinners — low molecular weight heparin and drugs sometimes called "super-aspirin" — had more than a 30 percent increased chance of major bleeding than those given the recommended dose....