Nearly five million patients have taken the drug since it was approved by the FDA 14 years ago and over 100,000 patients in the U.S. took the drug last year. Bayer estimates that Trasylol sales in the United States were over $90 million from January to September 2007 alone.

Germany, Canada and U.S. urge Bayer to stop sales

According to reports, regulators in the United States, Canada and Germany have been after the company to stop selling Trasylol until further studies could be done to better determine the drug's potential for harm. After a recent Canadian study revealed that patients taking Trasylol were more likely to die within 30 days after their heart procedure, Bayer reacted and announced that it would stop selling the product.

Trasylol's turbulent past

Several previous studies had found that Trasylol may increase the risk of kidney damage, heart failure, heart attacks and strokes. Although Bayer and the Food and Drug Administration (FDA) knew about these studies nearly two years ago, the FDA decided not to pull the product off the shelves. Instead, it added warning labels and restricted its use. However, the FDA later discovered that Bayer failed to apprise them about other studies that showed an increase in death among patients using the drug and ordered further investigation.

Temporary or permanent measures?

It's still unclear as to whether the drug will go back on the market once further investigation is done. According to a press release from the company:

Once [further information] is available, Bayer will work with health authorities to evaluate whether these data have any impact on the positive benefit-risk assessment for Trasylol. At that time, the temporary marketing suspension will be reevaluated.