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IC 93 articles

Scientists propose new testing standards for heparin

Scientists are proposing new standards for testing the quality and safety of heparin with new equipment that can analyze a broader range of impurities than the screening tools currently in use, according to the Daily Herald. The proposal stems from last year’s tainted heparin scandal that resulted in the deaths of more than 80 Americans and illness in hundreds more. Batches of heparin were later found to have been contaminated with oversulfated chondroitin sulfate (OSCS) during manufacturing at Baxter International’s China plant. OSCS is a heparin-mimicking contaminant that can cause serious allergic reactions in humans. The new standards were proposed ... Read More

Heparin producer's insurers file lawsuit

The insurance companies for Scientific Protein Laboratories’ parent company, American Capital Ltd., are suing to nullify the policies with the laboratory, according to The Daily Record. The Wisconsin-based company entered a joint venture with Baxter International Inc. to produce heparin in China. Last year, heparin produced at that plant was found to have been contaminated with oversulfated chondroitin sulfate (OSCS), a heparin-mimicking material that can cause life-threatening allergic reactions. The contaminated heparin killed more than 80 people in the U.S. and sickened hundreds more before several batches of the blood thinner were recalled. American Capital purchased 87 percent of Scientific ... Read More

Czech 'heparin murderer' gets life in prison

Petr Zelenka liked the excitement around crisis situations and the constant activity of hospital staff, which is why he pursued a position at an anaesthesiological-resuscitation ward at Havlickuv Brod hospital in the Czech Republic. To further his excitement, he administered heparin to patients between May and September 2006, which resulted in serious health complications and even death in some patients. Heparin is a blood thinner used to prevent blood clots. It is often given before surgery and during treatments such as kidney dialysis to prevent clotting. In appropriate use or overdosing can be fatal. This week, Zelenka – known to ... Read More

Lawmakers call for rule requiring drugs be made in U.S.

Lawmakers’ concern over the U.S. becoming too reliant on foreign countries to produce drugs are calling for a rule to require certain drugs to be made or stockpiled in the U.S., according to the New York Times. The Times quotes Sen. Sherrod Brown of Ohio as saying that relying on other countries to produce our country’s medicines opens the door to “supply disruptions, counterfeit medicines, even bio-terrorism.” Such is the case with the blood thinner heparin, which last year was the focus of much scrutiny when 80 Americans died and hundreds more were sickened after receiving doses of heparin manufactured ... Read More

FDA opens offices in India to help oversee drug importation

In an ongoing effort to ensure the safety of foods and drugs imported to the United States, the FDA is opening offices in foreign countries to oversee quality control of those products. The agency announced this week that it has opened two offices in India, according to Med Page Today. Last year the FDA announced it would place more than 60 food and drug regulators worldwide in an effort to keep unsafe drugs out of the country. Late last year the first offices opened in China, a country whose products have made headlines over the past several months for harming ... Read More

Torti named interim commissioner of FDA

FDA chief scientist and principal deputy commissioner Dr. Frank Torti will serve as the agency’s acting commissioner when Dr. Anderew Von Eschenbach leaves office this week, a position he will hold until the Obama administration appoints a new leader and the Senate approves the choice, according to Scrip World Pharmaceutical News. Dr. Torti joined the FDA in May, just as the tainted heparin scandal was still brewing at the agency. Dr. Von Eschenbach recruited Dr. Torti to “help bolster the agency’s scientific infrastructure,” according to the news story. Last year more than 80 Americans died and hundreds more became ill ... Read More

Lawmaker opens investigation into 'software glitches' at VA

Software “glitches” that lead to medical mishaps and prolonged infusions of drugs such as heparin administered to patients at Veterans Affairs hospitals throughout the U.S., which was reported by the Associated Press earlier this week, have raised concerns from the chairman of the House Veterans Affairs Committee, according to a new report by AP. Nearly one-third of the country’s 153 VA hospitals reported problems with the electronic medical records. Calling the findings a sign of “dangerous lack of accountability,” Rep. Bob Filner said he would investigate the matter that put the safety of VA patients risk. “VA continues to discover ... Read More

CDC study provides details on OSCS-laced heparin

The New England Journal of Medicine reported that the Centers for Disease Control and Prevention (CDC) in a study titled “Outbreak of Adverse Reactions Associated with Contaminated Heparin,” has confirmed the cause of serious adverse reactions in late 2007 were due to heparin contaminated with oversulfated chondroitin sulfate (OSCS). In the study, the CDC also determined that the contaminated heparin was linked to 152 adverse reactions in 113 patients from 13 states from Nov. 19, 2007 through Jan. 31, 2008. The study also reported, “the use of heparin manufactured by Baxter Healthcare was the factor most strongly associated with reactions ... Read More

FDA launches pilot project to oversee foreign drug products

The FDA announced today that it will launch a voluntary two-year pilot program to help promote the safety of drugs and active drug ingredients made outside the U.S. As part of the Secure Supply Chain program, the FDA will select 100 volunteers to maintain control over drug products beginning with when they are produced until it enters the U.S. The program is designed to assist the FDA in its efforts to “prevent the importation of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program ... Read More

Pharmacy tech steals bagfuls of heparin and other drugs

Pharmacy technician Wanda Lopez told guards she had left her wallet in the pharmacy at Shaughnessy-Kaplan Rehabilitation Hospital in Salem, Mass. Guards led her back to the pharmacy, where she used her key code to re-enter the room with the guards. She searched for her wallet and as her search became fruitless, guards left her alone. Shortly afterward, the guards saw Lopez walking around the hospital with a plastic bag covered by her coat. It was the third trip the pharmacy technician made to her car with bags taken from the hospital, according to a hospital employee. That’s when security ... Read More