Recalled Trasylol Heart Surgery Drug May Return To Market in Europe

European drug regulators indicate that the heart surgery medication Trasylol should be allowed back on the market, after questions have been raised about a study that led to the recall of Bayer’s drug. 

On Friday, the European Medicines Agency (EMA) issued a press release, recommending that a suspension of Trasylol in place in the European Union since 2008 be lifted.

A Trasylol recall was issued in the United States and other countries after the drug was linked to thousands of deaths worldwide due to kidney failure, heart attacks and strokes.

Originally approved by the FDA in 1993, concerns about Trasylol problems first gained national attention in early 2006, when preliminary data from a study suggested that the drug increased the risk of serious kidney damage, congestive heart failure, strokes and death.

Trasylol (aprotonin) was administered to an estimated 4.3 million patients in the hospital prior to heart surgery, but most people were not specifically aware of the name of the drug or that they were given it at all.  Therefore, many of the families of individuals who died following heart surgery with Trasylol were never aware that the death may have been caused by the medication.

After adding strong warnings to the drug, Bayer ultimately suspended sales in November 2007 and recalled Trasylol in May 2008, after the aborted BART study found it increased the risk of death by over 54% compared to alternative drugs to control bleeding in its preliminary results.

While reports suggest that there could have been more than 20,000 Trasylol deaths, the EMA’s Comittee for Medicinal Products for Human Use (CHMP) has determined that the drug’s benefits may outweigh the risks.

CHMP’s own investigation into Trasylol has led it to doubt the findings of the BART study, determining that the study had a number of problems. The committee found imbalances between the amount of heparin, a blood thinner, given to patients during the study, cases of inappropriate monitoring and data collection from patients. In addition, the study’s findings were not replicated in other research.

If the drug is returned to the market, CHMP recommends that doctors be warned about the risk of not giving patients enough heparin, and suggests that a registry should be established to track Trasylol use.

The determination follows a similar finding by Canadian health officials in September.

In the United States, Bayer continues to face hundreds of Trasylol lawsuits, involving allegations that the drug maker failed to exercise the proper degree of care in designing and testing the drug, and that it did not properly alert healthcare professionals and users to the risks of Trasylol side effects. Although the drug maker was aware of negative study results, some of the complaints allege that they delayed disclosing the data to the FDA and failed to issue adequate warnings. Bayer has reached Trasylol settlement agreements with some plaintiffs.