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arznei-telegramm 2011; 42: 63

 


Liver damage with UMCKALOABO: A 30-year-old woman took pelargonium root extract (UMCKALOABO) for four days for a respiratory infection in addition to other medicinal products. One day after the end of treatment she noticed yellowing of her skin and dark urine. During the subsequent stay in hospital her bilirubin levels were raised to a maximum of 16.3 mg/dl and SGOT and SGPT values to 1,637 U/l and 1,419 U/l, respectively. Ultrasound scanning showed the liver and bile ducts to be normal. There was no serological indication of hepatitis A, B or C. The physician making the report assessed the causal relationship with UMCKALOABO as highly probable (NETZWORK report 15.861). In a draft assessment report, the symptomatic efficacy of pelargonium root extracts in acute respiratory infections such as acute bronchitis, sinusitis, tonsillopharyngitis or common cold is assessed by the European Medicines Agency, EMA, as not properly proven (EMA: Assessment report on Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix, draft of 31 March 2011; http://www.ema.europa.eu/docs/en_GB/document_library/Herbal_-_HMPC_assessment_report/2011/06/WC500107717.pdf). Symptomatic treatment of common cold would be the only indication acceptable for the so-called traditional use (EMA: ebd.) For this traditional use it is enough for efficacy to be 'plausible', not proven. The Federal Institute for Drugs and Medical Devices (BfArM) has received altogether 17 reports of suspected hepatotoxicity related to pelargonium root extract (BfArM: correspondence dated 20 June 2011). In our NETWORK FOR MUTUAL INFORMATION we document three other reports of suspected cases, not yet recorded there (reports 13.705, 14.787 and 14.791). On account also of the lack of evidence of benefit according to our evaluation (a-t 2008; 39: 105-6) and the increasing number of reports of suspected cases of hepatotoxicity (cf. a-t 2006; 37: 41-2) we advise against its use, -ed.



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