Overview

This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of bladderwrack. The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing bladderwrack.

This summary is not intended to provide practical advice on how to use medicines containing bladderwrack. For practical information about using bladderwrack medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.

Bladderwrack is the common name for the seaweed Fucus versiculosus L., thallus.

The HMPC conclusions only cover bladderwrack preparations which are obtained by drying and powdering the seaweed.

Herbal medicines containing this bladderwrack preparation are usually available in solid forms to be taken by mouth.

Bladderwrack preparations may also be found in combination with other herbal substances in some herbal medicines. These combinations are not covered in this summary.

The HMPC concluded that, on the basis of its long-standing use, this bladderwrack preparation can be used in addition to a low-calorie diet to help overweight adults lose weight, after serious conditions have been excluded by a doctor.

Bladderwrack medicines should only be used in adults. If no weight loss is achieved after 10 weeks of taking the medicine a doctor or qualified healthcare practitioner should be consulted. Detailed instructions on how to take bladderwrack medicines and who can use them can be found in the package leaflet that comes with the medicine.

The HMPC conclusions on the use of these bladderwrack medicines for helping weight loss are based on their 'traditional use'. This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).

In its assessment, the HMPC considered a study indicating that a combined preparation containing bladderwrack reduced body weight in obese postmenopausal women. However, since this study used a combined preparation and showed shortcomings such as an inadequate statistical method, firm conclusions on the effects of bladderwrack could not be drawn.

For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.

At the time of the HMPC assessment, no side effects had been reported with these medicines.

Since bladderwrack medicines contain iodine, which may be toxic at high doses, the recommended dose should not be exceeded.

Bladderwrack medicines should not be taken at the same time as iodine preparations or medicines for the thyroid gland.

Further information on the risks associated with these bladderwrack medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab 'All documents' on the Agency's website.

Any applications for the licensing of medicines containing bladderwrack have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.

Information on the use and licensing of bladderwrack medicines in EU Member States should be obtained from the relevant national authorities.

Further information on the HMPC assessment of bladderwrack medicines, including details of the Committee's conclusions, can be found under the tab 'All documents'. For more information about treatment with bladderwrack medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.

Key facts

Latin name
Fucus
English common name
Bladderwrack
Botanical name

Fucus vesiculosus L.

Therapeutic area
Gastrointestinal disorders
Status
F: Assessment finalised
Date added to the inventory
Date added to priority list
Outcome of European assessment
European Union herbal monograph

Documents

First version

Consultation

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