BAYN Bayer AG

   By Kim Richters 
 

Bayer AG (BAYN.XE) said Monday that its Iberogast treatment is safe and that the death of a woman who had been taking the product in 2018 was most likely an idiosyncratic reaction to the drug.

Bayer issued a statement in response to a press report saying that state prosecutors in Cologne, Germany, are investigating the case. Bayer said it had not known of the investigation prior to the report.

The pharmaceutical company said it had thoroughly and intensively analyzed the case. "The analysis showed that this was most likely an idiosyncratic reaction--an extremely rare, dose-independent reaction to substances that are usually safely tolerated by humans," Bayer said, adding that such reactions are "substance-independent."

Bayer said Iberogast has been proven safe in clinical studies and in almost sixty years on the market.

Earlier Monday, German newspaper Handelsblatt reported that prosecutors were investigating a potential connection between the woman's death and Iberogast, a digestive medication. According to the newspaper, Bayer declined to add warnings about liver damage and failure for years to the medication's package leaflet. When the woman's death became known, the company added the warnings, the newspaper reported.

"Like all medicines, Iberogast is subject to constant and routine security oversight," Bayer said, which includes data from studies and consumer usage.

Write to Kim Richters at kim.richters@wsj.com

(END) Dow Jones Newswires

July 22, 2019 12:03 ET (16:03 GMT)

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