Serious hepatic reactions associated with the dietary supplement Fortodol

Herb-based dietary supplement contained active drug substance.

> The Medical Products Agency issues a warning against the herb-based dietary supplement Fortodol. The product has been on sale in Sweden since 2004. Analyses of the product revealed that it contains the drug substance nimesulide which is suspected to have caused serious liver injuries including liver failure and cardiovascular events with fatal outcome. At least 240 000 jars totalling 24 million capsules is reported having been sold in Sweden and Norway since 2004.

> The Medical Products Agency has received information about four cases of liver damage among Swedish patients who have taken Fortodol. In one of the cases, this led to acute liver failure resulting in death of the patient. The Norwegian Medical Products Agency has information about five cases of liver damage, and one case of death, with temporal association with the intake of Fortodol. It is known that the substance nimesulide can cause serious liver injury. Nimesulide is not an approved medicinal product in Sweden.

>  People consuming Fortodol should immediately cease the intake of it. Should you suffer from symptoms such as poor appetite, nausea, vomiting, abdominal pain, fatigue, dark urine or yellow skin, you should contact a medical care facility for a liver check up, says Barbro Gerdén, physician at the Medical Products Agency.

> The dietary supplement Fortodol, which is on sale on the Internet and in health food shops is said to relieve arthritis and muscle pains as well as head aches. The table of contents specifies that the product contains turmeric extract and the amino acid dl-phenylalanine. In two of nine analysed batches, the Medical Products Agency found the drug substance nimesulide.

> In those EU-countries where nimesulide is approved as a medicinal product the recommendations state that the substance should only be used for temporary treatments with prescriptions of not more than 30 doses. Fortodol has been sold in packages of up to 100 capsules.

> This is a product which has been launched as a dietary supplement, not as a medicinal product which implies a risk that people use it for longer periods of time, says Per Claeson, pharmacist at the Medical Products Agency.

> This is not the first time that the Medical Products Agency finds hazardous levels of drug substances in products sold as herbal products. Earlier examples are weight loss products and potency enhancers. This is the first time that an illegal drug substance has been discovered in a product used by people with painful disease states such as joint and muscle ailments. 

Case report on Nimesulide induced Angina