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contaminated heparin 33 articles

Lawmaker questions FDA investigation of heparin scandal

A Washington lawmaker is raising concerns about the FDA’s handling of the tainted heparin scandal earlier this year, claiming that the agency misrepresented deaths tied to the product and didn’t thoroughly investigate the situation, according to CNN Money. Batches of heparin were recalled by the FDA earlier this year after lots manufactured in China were found to have been contaminated with over-sulfated chondroitin sulfate. The investigation and subsequent recall followed reports of more than 80 deaths and thousands more illnesses of patients who had received doses of heparin from the lots in question. Rep. Joe Barton, R-Texas, last week pointed ... Read More

FDA opens first foreign office in Beijing this week

Following up on a story we brought you last month about the FDA setting up offices on foreign soil to provide guidance on U.S. food and drug quality standards, the FDA announced today that the first three of its offices will open this week in China, according to the Associated Press. The move is part of the agency’s effort to place more than 60 food and drug regulators worldwide over the next year. The offices replace the FDA’s previous practice of sending staffers on individual assignments to inspect foreign facilities. The agency’s Beijing office, which opens Wednesday, will be 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

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 ... 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

More products made in China recalled for harming infants

Will Chinese products be responsible for more deaths and hardships around the world? Early last year, more than 80 people died and thousands more were sickened after receiving the blood thinner heparin. It was later found that specific lots had been contaminated at a manufacturing plant in China. Even more were harmed recently when 50,000 children were sickened by milk from China that was contaminated by melamine, a product used in the manufacturing of plastics, fertilizer, paint and adhesives that can be lethal to infants. This, just a year after parents around the world were urged to dig through their ... 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

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. “We are sending a very clear message to producers: if you want to have access to our market you need to make products that meet our standards of quality,” Health and Human Services Secretary Michael Leavitt was quoted in the story. Leavitt oversees the FDA and other federal health agencies. ... Read More