Pharmaceutical

Tainted heparin may have caused death of infant

An infant may have been among the victims of the tainted heparin scandal earlier this year, according to WorldFocus consultant Peter Eisner, who has reported on the heparin crisis over several months. Eisner reports that Julien, the son of Alex and Ann Oryschak, died Nov. 19, 2007, after becoming ill. The Oryschaks believe that heparin may have lead to their infant son’s untimely death, and they want to share their story in hopes of influencing changes in drug regulations.

Last year, heparin was thrust into the spotlight after more than 80 patients who had received the blood thinner died and hundreds more became ill. An investigation to the adverse reactions found that batches of heparin manufactured in Baxter International’s China plant were contaminated with over-sulfated chondroitin sulfate (OSCS). That discovery spurred the FDA to recall lots of heparin made by Baxter International.

“Perhaps the most surprising fact that emerged in our three months of reporting on contaminated heparin ingredients from China: The U.S. government has little ability to know whether the drugs we are taking are safe or not,” Eisner points out.

Last month, the FDA vowed to step up its efforts to oversee quality control of imported foods and drugs by opening offices in foreign countries. Its first offices opened in China. The FDA plans to place more than 60 food and drug regulators worldwide over the next several months. However, the agency says it will take more than a decade to adequately inspect all foreign drug manufacturing plants.

“As a result,” Eisner writes, “doctors must take it on faith that the medicines they are prescribing are exactly what they are supposed to be.”