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Bayer To Investigate Mistake Over Drug Safety

Added October 26th, 2006

Pharmaceutical giant Bayer is to launch an investigation to find out how drug safety information was not provided to the Food and Drugs Administration following a study into the safety of one of its drugs. The drug safety study was carried out on the company’s heart surgery drug Trasylol, but the pharmaceutical company failed to inform the FDA about the results.

Bayer is now blaming two of its employees for the error, and legal aid has been hired to find out how such a mistake could have been made. The drug was approved by a panel in September of this year, but the agency discovered just days later that Bayer had not informed it of a vital safety study that had been carried out.

It is alleged that the FDA only found out about the safety study on Trasylol because of an outside source that the pharmaceutical company used to help with the study. One official stated that Bayer’s failure to disclose details of the study might be classed as a violation of the law.

Sidney Wolfe, of the watchdog group Public Citizen, stated: "The thing that's most concerning to me is the withholding of data is a criminal offense. They can say it's a mistake all they want, but it's a fairly big time mistake to make."

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