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Herbal Painkiller Linked to Liver Failure

Mar 26, 2009 | Parker Waichman LLP

An herbal painkiller sold by a California company is the subject of a health warning in the United Kingdom (UK).  According to the Food Standards Agency (FSA), the supplement, known as Fortodol or Leppin Miradin, has been linked to reports of serious liver failure, including two deaths.

Fortodol is marketed by the California-based firm Donsbach.  According to promotional material, Fortodol is a concentrated form of turmeric, which is a common food, used in curry powder.  Donsbach claims that Fortodol is a "very safe" and effective treatment for arthritis, migraine, sciatica, and  muscular pain.  

According to the FSA, Fortodol being sold in Europe has been found to contain a drug called nimesulide.  Nimesulide, marketed under the names Aulin and Mesulid, was introduced in the 1980s.  It has been sold in approximately 50 countries, but has never been approved in the U.S. The drug is used in the treatment of acute pain, the symptomatic treatment of osteoarthritis and primary dysmenorrhoea in adolescents and adults above 12 years old. Due to concerns about the risk of liver damage, nimesulide has been withdrawn from the market in many countries, including the UK.

According to the FSA, there have been 11 liver-related adverse event reports in Sweden and a further five in Norway among people taking Fortodol.  Two of those adverse events involved fatalities.

According to an FSA Statement: “There have been no reports of liver failure or illness linked with these products in the UK. As a precautionary measure, however, these products have been voluntarily withdrawn from sale by the two main importers and recall notices will be placed in the shops selling these supplements.”

Consumers have also been advised to consult a doctor if they experience symptoms of liver damage, including poor appetite, nausea, vomiting, abdominal pain, fatigue, dark urine or yellow skin.

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