Warning for Pelargonium

After a long discussion and despite new studies, the manufacturers of Pelargonium-containing medicines must point out the risk of liver damage from 1 July. This has finally been decided by the BfArM.

09/04/2014

According to the final report of the Federal Institute for Drugs and Medical Devices (BfArM), the use and technical information must be supplemented with the addition: „Cases of liver damage and hepatitis have been reported in association with the use of pelargonium-containing medicines; the frequency is unknown“.

In addition, consumers should be advised to stop taking any sign of liver damage - yellowing of the skin or eyes, dark urine, severe upper abdominal pain, loss of appetite - and seek medical attention.

With a corresponding decision, the BfArM ends the phased plan procedure initiated in October 2011, about which we have already reported several times. At that time there were increasing reports of liver damage after taking Umckaloabo.

Within one month an objection can be filed against the decision. Besides Umckaloabo (Dr. Willmar Schwabe), the generics of Ratiopharm (Pelargonium Ratiopharm bronchial drops) and Hexal (Pelasya) are also affected. (Pm)