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Thursday 27th October 2016

'Thousands die' from Bayer drug

19th February 2008

A leading researcher into the effects of a drug produced by Germany's Bayer has said that as many as 22,000 people could have been saved if drug regulators had acted faster.


If the Food and Drug Administration (FDA) had moved more swiftly to pull Bayer Trasylol, which was used to stem bleeding during open heart surgery, from the market, those people might have survived, according to Dennis Mangano.

Mangano led a study probing the effects of Trasylol, which has now been linked to kidney failure resulting in the need for dialysis, and death.

The report estimates the drug was given to as many as a third of all heart bypass patients in the US over a period of many years.

In a report broadcast on the CBS television network, Mangano said Bayer failed to disclose the results of its own studies which had made the company aware of the dangers during the key meeting in September 2006, during which Mangano's own negative findings were discussed.

FDA officials have since said they would have recalled Trasylol if they had known about Bayer's findings at that time.

Bayer is facing a number of lawsuits from patients or relatives of those who had taken the medicine.

Bayer halted worldwide sales of Trasylol on 5 November 2007, under increasing government pressure in the wake of another negative study into the effects of Trasylol in Canada.

Lawyers for some of the patients and relatives concerned said they were already seeking damages for deaths thought to be linked to the use of Trasylol.

One of the cases publicised on the CBS report was that of Joseph Randone, a 52 year old man who suffered kidney failure leading to his death following routine valve replacement surgery at Stony Brook Hospital, New York.

Attorney Marc Jay Bern said older tried and tested medications were often ignored in the face of new and untested medications that had been heavily promoted by the manufacturers.

Bern said the litigants would sue for 'tens of millions of dollars' because of Bayer's reckless marketing. Some lawsuits were related to Bayer's Baycol and Factor 9 medications.

Trasylol was approved by the FDA in 1993 and prior to its withdrawal from the market was favoured because of its ability to reduce an inflammatory response, decreasing the need for blood transfusions.

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