The new study, as reported by Forbes.com, includes an examination of Trasylol use in 49 randomized clinical trials, and also includes new information from the Blood Conservation Using Antifibrinolytics in a Randomized Trial (BART) study, published earlier this year. The findings of the new study, which was conducted by Canadian and Australian reserachers, will be published in the Jan. 20 issue of the Canadian Medical Association Journal.

Trasylol had been used extensively since 1987, and was only pulled from the U.S. market by manufacturer Bayer in November 2007. It seems incredible that a product that recent tests have proved significantly more dangerous than other similar drugs could have flown under the radar for 20 years.

The BART study revealed that patients treated with Trasylol were 53 percent more likely to die than patients treated with similar drugs. The study compared Trasylol (aprotinin) with two other drugs, Cyklokapron (tranexamic acid) and Amicar (aminocaproic acid).

The new Canadian-Australian study confirms the BART results, saying Trasylol carries a higher risk of death, and, to add insult to injury, a significantly higher price tag than its alternatives.

According to the Forbes report, some of the blame for Trasylol’s longevity in the marketplace is being placed on the U.S. Food and Drug Administration.

SOURCE: Trasylol Recall › Follow-up to Canadian BART study confirms Trasylol risks

Journal editor Dr. Jeffrey M. Drazen says the litigation process and the court system is a “key defense mechanism” to insure drug safety and to obtain justice if drug manufacturers have not made the risks involved with its product clear.

The doctors say the FDA is incapable of being the sole guardian of drug safety and that without the information supplied by liability litigation, “the American public would be deprived of a vital deterrent against pharmaceutical company misconduct.”

The opinion was submitted to the Supreme Court as a friend-of-the-court brief in the matter of Wyeth v. Levine, a case expected to be heard later this year. According to the AP story, the case involves Diana Levine, a guitarist who lost her right arm below the elbow after an injection of Phenergan. She sued the drug’s manufacturer, Wyeth, alleging the company had not adequately warned consumers of the risks associated with its product. The case was tried in Vermont, and the court agreed, awarding Levine $7 million.

Wyeth is appealing the case, saying the FDA had approved the drug, and that the state court could not overrule the FDA’s judgment.

However, the editors of the New England Journal of Medicine sided with 47 state attorneys general and two former FDA commissioners in supporting Levine’s position, the AP report states.

SOURCE: Trasylol Recall › physicians favor drug safety litigation