False information on Sorbex active charcoal product can result in danger
The Poison Information Centre warns that the false information provided in the package leaflet and advertising of activated charcoal product Sorbex marketed by Sabora Pharma Oy as a food supplement can result in danger.
It has come to the knowledge of the Poison Information Centre that the package leaflet and advertising of activated charcoal product SorbexTM marketed as a food supplement contains false and dangerous misleading information. The package leaflet recommends that the product can be used e.g. "if toxins, such as alcohol, are excessively accumulated in the body". Research has shown that activated charcoal does not absorb alcohol and therefore should not be used to treat alcohol poisoning. Ingesting activated charcoal in order to prevent or treat alcohol poisoning can cause a dangerous situation.
Advertisements claim that when ingested in a dose of 1-3 capsules (300-900 mg) a day for 3-15 days, SorbexTM "..is an effective treatment that reduces the adsorption of toxic substances from the intestines. A poisoning can result from, for example, excessive consumption of alcohol or eating drugs or poisonous mushrooms". Activated charcoal is used as a first aid measure in acute poisonings as it can prevent the adsorption of many substances from the intestines, but e.g. alcohol is not one of these substances. The dose of activated charcoal used in the treatment of poisoning is 50-100 g for adults, i.e. 50-300 times greater than the dose recommended in the package leaflet and advertising of SorbexTM. If in a suspected case of poisoning caused by e.g. mushrooms or drugs 300-900 mg of activated charcoal is ingested without taking any other action in the belief that the dose is sufficient to prevent significant poisoning, a life-threatening situation may occur depending on the type and amount of the toxic substance.
The Poison Information Centre emphasises that activated charcoal products, which meet the quality requirements laid down for a medicine still play an important role in the first-aid treatment of acute poisonings. However, the dose of activated charcoal has to be adequate and activated charcoal is not to be used if the poisoning is caused solely by alcohol, iron, a petroleum product (e.g. barbecue lighter fluid, gasoline or lamp oil) or a corrosive substance.
Finnish Food Safety Authority Evira's communication about the matter:
Finnish Food Safety Authority Evira has initiated urgent action to remove the product Sorbex from the market, to discontinue its marketing that violates regulations and to publish a corrigendum regarding marketing. Action will also be taken to recall the product from consumers.
Finnish Medicines Agency Fimea's communication about the matter:
Finnish Medicines Agency Fimea has on 24 November 2011 started a procedure to classify the product Sorbex as a medicine on the basis of the medicinal purpose of use of the product and inappropriate marketing. The treatment of poisoning is considered a medicinal indication. Fimea is by virtue of Section 6 of the Medicines Act authorised to decide whether a product is considered a medicine. Products included within the scope of the definition provided in Section 3 of the Medicines Act are considered medicines.
More information about the matter is in the Poison Information Centre provided by:
Outi Lapatto-Reiniluoto, Acting Medical Director (tel. +358 9 471 76 595, outi.lapatto-reiniluoto
More information about the matter is at Evira provided by:
Anna Mizrahi, Senior Officer, Product Safety Unit (anna.mizrahi
evira.fi, tel. +358 40 685 5196).
More information about the matter is at Fimea provided by:
Kristiina Pellas, Senior Pharmaceutical Inspector, Unit of Medicinal Safety and Medicinal Information (tel. +358 9 4733 4336)