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Scientists on road to modifying, customizing human heparin

Scientists at University of North Carolina at Chapel Hill have learned to modify the human enzyme that produces heparin, which may lead to a more effective synthetic version of the blood thinner, according to Newswise Medical News. “Previously it was nearly impossible to change the nature of the heparin generated by the enzyme,” said Jian Liu, Ph.D., associate professor at the UNC Eshelman School of Pharmacy medicinal chemistry and natural products division. “The degree of difficulty was 10-plus. Now it’s more like a two or three, which opens the door to the possibility of improving on the natural product.” The ... Read More

Time shares story of family affected by heparin contamination

A recent Time magazine story gives us a glimpse into a family affected by the contaminated heparin tragedy: Leroy Hubley’s wife of 48 years, Bonnie, suffered from polycystic kidney disease, a genetic kidney disease in which cysts grow in the kidneys, causing them to fail. She received a kidney transplant in October 2007, but her body rejected it, leaving her in need of regular dialysis treatments. During dialysis, patients are hooked up to a machine that draws out the blood through tubing. Since blood tends to clot when it moves through the tubing, patients routinely are given the blood thinner ... Read More

Doctors outraged by heparin seizure

ConsumerAffairs.com is reporting that doctors are outraged that recalled batches of heparin were found in a Cincinnati, Ohio lab. “It’s really horrible for two reasons: one, that a company that knows that their product is not a good product that should be distributed and they’ve been told so,” said Dr. Lynne Wagoner, a Christ Hospital Heart Specialist, who was quoted in the story by WTOL-TV in Toledo, Ohio. Earlier this month, U.S. Marshals seized a total of 11 lots of the blood thinner at Celsus Laboratories Inc. Heparin was recalled earlier this year after an FDA investigation found that batches ... Read More

Glycotek developing oral alternative to heparin

A drug development company, Glycotek, is establishing a laboratory at the Hershey Center for Applied Research (HCAR) in Hummelstown, Penn., to focus on a long sought after oral alternative to heparin to treat deep vein thrombosis and other thrombotic conditions, as well as cancer, according to Business Wire. Heparin is a blood thinner that is routinely used before certain types of surgery or other procedures to prevent clotting. It also is widely used for patients with chronic thrombotic conditions. Heparin is administered intravenously, which requires constant monitoring of doses and in-patient hospital stays. An oral alternative could reduce the need ... Read More

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. The method uses a machine that removes blood from a patient through an IV, separates it into red blood cells and plasma, and returns the red blood cells back into the patient’s arm. The plasma is then infused with the blood thinner heparin, which binds to the low-density lipoprotein (LDL), or “bad” cholesterol, and separates from the plasma. The LDL is then filtered out and the remaining plasma ... Read More

Chantix plays role in record number of drug reactions

According to The Institute for Safe Medicine Practices (ISMP), the number of drug-related adverse events and deaths reported to the Food and Drug Administration has hit a record level. Numbers pulled from the FDA’s Adverse Event Reporting System (AERS) reveal that Heparin and Chantix are largely to blame for the upward swing. The dramatic increase of pharmaceutical drug related injuries occurred in the first three months of 2008, during which time 20,745 serious side effects and more than 4,800 deaths were reported. The incidents represent a 38 percent rise over the previous four quarters and constitute the single highest spike ... Read More

Researchers recommend new Chantix warnings

Researchers at the Institute for Safe Medicine Practices, a nonprofit organization, and Wake Forest University say that their latest review of Chantix data justifies stepping up warnings about the drug. More than 1,000 complications were reported in the first quarter of 2008, including 15 traffic accidents, 52 incidents of loss of consciousness and blackouts, and 50 deaths. Reports of adverse effects among users taking Chantix were greater than any other prescription drug for the second quarter in a row. While the drug already urges caution while driving and operating machinery, the new reports suggest a stronger warning may be justified. ... Read More

FDA will not name Chinese plants that supplied tainted heparin

The U.S. Food and Drug Administration (FDA) is at odds with congressional investigators over an investigation into the federal agency’s inspection of foreign drug manufacturing facilities. The report revealed that inspecting the more than 3,000 overseas drug plants would take the FDA more than 13 years to complete The agency fired back, saying “The conclusion that FDA should endeavor to conduct foreign inspections based on the same criteria as domestic inspections is…problematic because of the differences in regulatory methodology and resources,” according to the Associated Press. The need for careful inspections of foreign drug manufacturing plants has come to the forefront ... Read More

FDA inspections of foreign drug facilities could take years

This year’s contaminated heparin scare that seriously harmed hundreds of Americans has taught us one thing – we need a better system of ensuring that drugs manufactured in foreign markets are safe for Americans. The U.S. Food and Drug Administration (FDA) recently announced that it will place more than 60 food and drug regulators worldwide over the next year to inspect foreign drug manufacturing plants. However, congressional investigators say inspecting the more than 3,000 drug plants in other countries could take as long as 13 years, according to the Associated Press. In comparison, U.S. pharmaceutical factories are inspected by the ... Read More

Pharmaceutical companies developing drugs to fight blood clots

Five pharmaceutical companies are working on new medications to treat blood clots, also known as thrombosis, according to The Wall Street Journal. Thrombosis is a serious problem affecting nearly 900,000 Americans each year, and resulting in nearly 300,00 deaths annually. Currently, heparin and Vitamin K antagonists are the only two principal treatments for blood clots. The blood thinner heparin made news recently when the FDA recalled batches of heparin after more than 80 people died and several others became ill after receiving heparin. It was later determined that heparin made by Baxter International was contaminated in the company’s Chinese manufacturing ... Read More