Publications

Published: March 2012

Nicobrevin - Do the Benefits Outweigh the Risks?

Prescriber Update 33(1): 2-3
March 2012

Following the withdrawal of Nicobrevin in the United Kingdom, Medsafe requested a review of the benefits and risks of this medicine from the product sponsor. The Medicines Adverse Reaction Committee (MARC) reviewed this information along with information about the individual ingredients contained in Nicobrevin.

Nicobrevin is used as an aid to quitting smoking and contains: menthyl valerate, camphor, quinine and eucalyptus oil. These ingredients are claimed to help to relieve the symptoms associated with stopping smoking.

The MARC considered that studies reviewed in support of the efficacy of Nicobrevin provided little evidence of benefit. Studies reviewed included the Dankwa et al. study conducted in 92 smokers in 1988 and a recently updated Cochrane review1,2.

However, despite the paucity of evidence of efficacy in the scientific literature, the MARC noted that even if this product only had a placebo effect this might still be helpful in enabling smokers to quit.

There was little evidence of frequent serious harm occurring with the use of Nicobrevin, although the following was noted:

The MARC concluded that there was insufficient evidence demonstrating serious harm to justify removing the product from the New Zealand market.

To provide more information for patients and minimise the risk of adverse effects, the MARC recommended that the Nicobrevin package label and package insert be updated to reflect the risk of adverse reactions. Medsafe is working with the sponsor to update the label.

References
  1. Dankwa E, Perry L, Perkins A. 1988. A double-blind, placebocontrolled study to determine the efficacy of Nicobrevin anti-smoking capsules. British Journal of Clinical Practice, 42(9): 359-363.
  2. Stead LF, Lancaster T. 2006. Nicobrevin for smoking cessation. Cochrane Database of Systematic Reviews, Issue 2, Art. No. CD005990. DOI: 10.1002/14651858.CD005990.
  3. European Medicines Agency. 2006. Community herbal monograph on Valeriana officinalis L., radix. Doc. ref. EMEA/ HMPC/340719/2005. URL: www.ema.europa.eu/docs/en_GB/document_library/Herbal_-_Community_herbal_monograph/2009/12/WC500017925.pdf
  4. Brasic JR. 2001. Quinine-induced thrombocytopenia in a 64-year-old man who consumed tonic water to relieve nocturnal leg cramps. Mayo Clinic Proceedings, 76(8): 863-864
  5. Bel B, Jeudy G, Bouilly D, et al. 2009. Fixed eruption due to quinine contained in tonic water: positive patch testing. Contact Dermatitis, 61(4): 242-244