FRANKFURT: German drugmaker will add a warning of rare cases of liver damage to the label of prescription-free stomach relief drops Iberogast after Germany's drugs regulator said a death was linked to the product.
Drug safety watchdog BfArM said Bayer had dropped a legal challenge against a stricter warning after fresh reports of liver damage in users of the drops, including one patient who died after receiving a liver transplant.
Bayer confirmed it would amend the label to exclude people with liver disease as well as pregnant or breast-feeding women from the targeted patient group. The label also now says that treatment should be stopped on signs of liver damage.
"Iberogast's safety and efficacy has been confirmed over the course of the treatment of more than 82 million patients since market launch," the company added.
The product was introduced in 1960 and is approved in more than 40 countries. Bayer declined to say how much revenue the product generates.
Bayer acquired the brand as part of the 2013 takeover of Steigerwald, an unlisted maker of herbal remedies. At the time the company had annual sales of about 60 million euros (US$70 million).
Steigerwald, and later Bayer, have fought a stricter Iberogast product label in German court since 2008.
Steigerwald became part of Bayer's consumer health unit, which had 5.9 billion euros in sales last year. The division is trying to reverse a decline in sales due to fierce competition from cheaper brands.
(Reporting by Patricia Weiss; Writing by Ludwig Burger; Editing by Louise Heavens)