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IC 93 articles

Drug company launches Web site to highlight safety measures

The sole provider of heparin in the United States, APP Pharmaceuticals LLC, has launched a Web site as a first step toward improving the safety of the medications it sells in the U.S., according to Reuters. The Web site details the safety measures the pharmaceutical company has taken over the past several months, including enhanced labeling, unit-of-use bar codes, large lettering and color-coded bottle stoppers to help eliminate misuse of its products, which also includes injectible drugs for oncology. APP Pharmaceuticals became the only U.S. provider of the blood thinner heparin after batches of heparin manufactured at Baxter International’s Chinese plant ... Read More

Daschle likely to inherit agency rife with issues

President-elect Barack Obama has made no formal announcement as yet, but it appears likely that Sen. Tom Daschle will be appointed Obama’s choice for Health and Human Services secretary, according to The Federal Times. If so, Dashle will inherit a department that oversees the FDA, an agency that is rife with issues. The agency has been the subject of criticism over its handling of the tainted heparin scandal earlier this year in which more than 80 Americans were killed and hundreds more sickened after receiving injections of heparin from China. The FDA, struggling with low staff levels, is gradually hiring ... Read More

Generics may be bio-equivalent of brands, but are they as safe?

Clinical tests conducted by the Journal of the American Medical Association comparing brand and generic cardiovascular drugs show that generic drugs are bio-equivalent to the drugs they are patterned after. And, the FDA adds, generics are far less expensive than brand-name drugs. However, U.S. News & World Report raises questions about the quality of the generic drugs. First, researchers noted that the evaluations were short term and that many of the studies were supported by the generic drug companies, who have a vested interest in the positive outcome of the results. Furthermore, the story points out that generics are more ... Read More

FDA requests better labeling of low molecular weight heparin

The FDA announced this week that it has received information about the Innohep in Renal Insufficiency Study (IRIS) that was stopped in February because of an interim finding of increased all-cause mortality in patients who received Innohep. Innohep contains tinzaparin sodium, a low molecular weight heparin that is given to patients in conjunction with warfarin sodium intravenously to treat blood clots that have occurred deep in the veins of hospitalized patients who may or may not have also experienced the occurrence of blood clots in their lungs (pulmonary embolism). At the time the study was stopped, 350 patients had completed ... Read More

MIT report proves type of contaminant in Chinese heparin

A team of researchers from the Massachusetts Institute of Technology (MIT) has confirmed that over-sulfated chondroitin sulfate was, in fact, the contaminant in heparin that was manufactured in China and triggered serious allergic reactions that caused more than 80 Americans to die and hundreds more to be sickened earlier this year, according to ABC Action News. Researchers identified the contaminant last April and noted how it could lead to severe allergic reactions. This new MIT report documents the reactions and specifically links them to batches of heparin that were manufactured in Baxter International’s Chinese facility. The findings were published in the ... Read More

Baxter International spent thousands on lobbying efforts

Drug maker Baxter International Inc., shelled out more than $720,000 in the third quarter of the year lobbying on health care issues including government reimbursement for kidney dialysis treatment and increased funding for kidney disease education, according to Forbes/Associated Press. Baxter International makes heparin, the blood thinner that is routinely used before treatment for kidney dialysis to prevent blood clots as well as during many surgeries. Several lots of heparin manufactured in Baxter International’s China plant were recalled by the FDA earlier this year after they were found to have been contaminated during manufacturing. The tainted heparin ultimately killed more ... Read More

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

Heparin overdose at hospital kills Australian man

A lack of communication among hospital staff lead to an inappropriate injection of heparin that lead to the death of an Australian man earlier this year, according to Hawke’s Bay Today. The victim, who had complained of chest pains for three weeks, was admitted to Hawke’s Bay Hospital in January. Doctors diagnosed him with unstable angina and administered Enoxaparin, a low molecular weight heparin manufactured by Sanofi-Aventis. A half-hour later he was diagnosed with acute lateral myocardial infraction, or a heart attack, and was given another dose of heparin. Within hours, the overdose caused his gums to bleed and his ... Read More

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

Researchers find new method to detect contaminant in heparin

Researchers have come up with an easy and effective method to detect contaminates in heparin, according to the Times of the Internet. A research team led from the University of Michigan and led by Mark Meyerhoff uses potentiometric polyanion sensors to detect heparin in blood. These sensors also can be used to distinguish pure heparin from heparin contaminated with small quantities of oversulfated chondroitin sulfate. This new method is easier and less expensive than analytical methods used previously, such as nuclear magnetic resonance and capillary electrophoresis. Meyerhoff and his team detailed the research in the journal of Analytical Chemistry. Oversulfated ... Read More