Unlicensed herbal product found to contain the antihistamine, chlorphenamine - update

All herbal safety warnings and alerts

7 September 2011

Following our original safety alert dated 8 April 2011, the Agency carried out further further testing on Beline Capsules. The capsules have been found to contain the following undeclared pharmaceutical ingredients:

  • chlorphenamine
  • oxetacaine
  • piroxicam
  • betamethasone.

This is consistent with earlier findings by the Danish Medicines Agency (external link).

Beline capsules are an illegal unlicensed medicinal product which cannot legally be sold in the UK without first obtaining either a marketing authorisation (MA) or traditional herbal registration (THR). The distributor, FocusHR Limited, has agreed to discontinue sale of the product in the UK.

However, consumers, particularly those who may have purchased several months supply, should be alert to the potential dangers of continued use of this product. The MHRA strongly advises that anyone using this product should stop taking it and consult their healthcare professional immediately with the details contained in this notification.

Possible side effects
The MHRA has received five reports of side effects suspected to be associated with the use of Beline capsules. These include reports of high blood pressure, palpitations, chest pain, sleep disturbances, cramps, bruising and thinning of skin. A report of a suspected side effect does not mean the Beline capsules were definitely responsible but that there was a strong suspicion of a causal relationship.

If you have experienced any adverse reactions while taking Beline capsules or any other herbal or conventional medicine please report it to a healthcare professional or directly to the Yellow Card scheme.

  • Chlorphenamine is an antihistamine, which is used to treat allergies
  • Oxetacaine is a local anaesthetic
  • Piroxicam is used to relieve pain and reduce fevers
  • Betamethasone is a corticosteroid

Page last modified: 07 September 2011