Heparin Drug

Biopool International Inc., a Ventura producer of test kits for diagnosing blood disorders, says it has acquired a new technology for the early detection of potential complications in patients receiving heparin, a drug used in treating blood-clot diseases. The complication may occur in as many as 10% of patients who receive the drug. The new technology was developed at the University of Alberta Hospitals in Alberta, Canada.

A new appeal in a conflict-of-interest controversy involving the Food and Drug Administration's handling of the deadly heparin contamination crisis of 2008 has shed more light on the convoluted and costly maneuvering that can break out when billions of dollars in profits are at stake. The latest round began last week when Amphastar Pharmaceuticals Inc. of Rancho Cucamonga said it would appeal the FDA's rejection of a complaint. The privately held drug maker alleged that Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, had a conflict of interest.

A new appeal in a conflict-of-interest controversy involving the Food and Drug Administration's handling of the deadly heparin contamination crisis of 2008 has shed more light on the convoluted and costly maneuvering that can break out when billions of dollars in profits are at stake. The latest round began last week when Amphastar Pharmaceuticals Inc. of Rancho Cucamonga said it would appeal the FDA's rejection of a complaint. The privately held drug maker alleged that Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, had a conflict of interest.

Baxter International Inc.'s blood thinner heparin didn't cause deaths at a Delaware hospital, according to the company's investigation. The three patients who suffered bleeding in the brain last week at Beebe Medical Center in Lewes were "isolated" and "institution-specific" cases, the drug maker said.

Baxter International Inc.'s blood thinner heparin didn't cause deaths at a Delaware hospital, according to the company's investigation. The three patients who suffered bleeding in the brain last week at Beebe Medical Center in Lewes were "isolated" and "institution-specific" cases, the drug maker said.

An anti-clotting drug appears to sharply reduce the chances that patients suffering from severe chest pain will be stricken by heart attacks, Canadian researchers report. Researchers from the University of Montreal found that both aspirin and the long-used drug heparin significantly reduced the chances that those experiencing chest pain would have heart attacks.

Newly available blood-thinning medicines should allow many of the 400,000 Americans who suffer dangerous clots each year to be treated at home, rather than spend a week in the hospital, researchers say. Two studies from Canada and the Netherlands published in today's New England Journal of Medicine show that the drugs can be injected safely and effectively for treatment of a common condition called deep-vein thrombosis.

A spongelike plastic device implanted under the skin near arteries may help to prevent hardening of the arteries, researchers from the Harvard Medical School said last week at the ACS meeting. The implant acts something like a sponge, Dr. Elazer Edelman said, allowing the blood-thinning drug heparin to diffuse through tiny, porelike holes over a period of weeks or months.

The investigation into a blood thinner suspected in some 19 U.S. deaths is now focusing on the possibility that raw biological ingredients were contaminated even before they reached a factory in China, manufacturer Baxter Healthcare Corp. said Friday. That raises the prospect that the problem could have occurred somewhere along a supply chain that includes layers of middlemen and originates in pig farms. Heparin, a generic medication, is derived from a substance in the lining of pig intestines.

Slightly increasing the dose of a drug commonly used to treat heart attacks almost doubles patients' risk of devastating strokes, two studies published Monday said. The findings on the drug heparin caused researchers to suspend the studies in April, and in Monday's edition of the journal Circulation they warned doctors to be careful. "We didn't know there was a dark side to heparin," study co-author Dr. Eric Topol of the Cleveland Clinic said. "We learned it has a very narrow window for safety."

U.S. marshals seized 11 contaminated lots of the blood-thinner heparin made from Chinese ingredients by a maker that ships to drug and device manufacturers in several countries. The marshals took the drugs from closely held Celsus Laboratories Inc. in Cincinnati, the Food and Drug Administration said. The action followed unsuccessful efforts to persuade the company into an "effective" recall, the FDA said.

The scope of concerns about the possible ill effects of a contaminated blood thinner from China grew significantly Tuesday as federal regulators urged makers of many kinds of medical devices that contain the drug to test their supplies. The products to be tested cover a spectrum of equipment and uses.

The investigation into a blood thinner suspected in some 19 U.S. deaths is now focusing on the possibility that raw biological ingredients were contaminated even before they reached a factory in China, manufacturer Baxter Healthcare Corp. said Friday. That raises the prospect that the problem could have occurred somewhere along a supply chain that includes layers of middlemen and originates in pig farms. Heparin, a generic medication, is derived from a substance in the lining of pig intestines.

Baxter International Inc. said Thursday that it had recalled the remaining lots of its troubled blood-thinning drug heparin as U.S. regulators reported "objectionable conditions" at the Chinese factory that supplied the raw ingredient for the drug. Heparin has been linked to four deaths and hundreds of adverse reactions and is the subject of an investigation by the Food and Drug Administration. It is not known whether the Chinese plant is the cause of the problems, the FDA said.

Li Li, a drug industry veteran, spent almost five years getting his heparin plant ready for U.S. regulatory approval. It was an arduous process, he said, displaying thick black binders with detailed documentation of his operations here. And his timing couldn't have been better. Heparin, a widely used blood thinner, was once made from cow lungs. Drug makers shifted to pig intestines as concerns over mad cow disease heightened in the 1990s, and no place has more hogs than China.

The maker of a blood thinner suspected in four U.S. deaths and allergic reactions in 350 people said Tuesday that its investigation was focusing more closely on whether something went awry during the processing of ingredients in China. Baxter Healthcare Corp. spokeswoman Erin Gardiner said testing had detected irregularities in samples of the drug, heparin, that were processed in China from raw material extracted in China.

Analysts say Genentech Inc. has done a masterful job of building brand loyalty among doctors for its most important product, the heart attack drug TPA. But because of an Italian study showing TPA--at $2,200 a dose--to be no more effective than a rival drug costing less than one-tenth as much, doctors may be hard pressed to justify TPA to cost-conscious hospitals. A University of Michigan professor of medicine, Dr.

U.S. marshals seized 11 contaminated lots of the blood-thinner heparin made from Chinese ingredients by a maker that ships to drug and device manufacturers in several countries. The marshals took the drugs from closely held Celsus Laboratories Inc. in Cincinnati, the Food and Drug Administration said. The action followed unsuccessful efforts to persuade the company into an "effective" recall, the FDA said.

Testing has turned up possible irregularities in some samples of a blood thinner linked to several deaths and hundreds of life-threatening reactions, a spokeswoman for Baxter Healthcare Corp. said Thursday. The disclosure comes amid mounting questions about the U.S. Food and Drug Administration's oversight of drugs manufactured overseas.

Newly available blood-thinning medicines should allow many of the 400,000 Americans who suffer dangerous clots each year to be treated at home, rather than spend a week in the hospital, researchers say. Two studies from Canada and the Netherlands published in today's New England Journal of Medicine show that the drugs can be injected safely and effectively for treatment of a common condition called deep-vein thrombosis.