Over-the-counter antibiotic recommended for removal from European Market

EMA: Recommendation to remove fusafungine from market
A review by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has recommended that the marketing authorisation for fusafungine nose and mouth sprays, widespread over-the-counter antibiotic treatments for upper respiratory tract infections (URTIs), be withdrawn across Europe. The review concluded that the benefits of fusafungine-containing medicines do not outweigh its risks, particularly the risk for serious allergic reactions. The potential for fusafungine use to contribute towards antibiotic resistance was also considered [EMA 2016].

Use of antibiotics for treatment of URTIs
URTIs are common, self-limiting conditions, predominantly caused by viruses [Francis 2009, Spinks 2006, Worral 2007]. Antibiotics are not effective against viruses and therefore the majority of URTIs are unlikely to respond to treatment. Despite this, URTIs account for a large proportion of antibiotic prescriptions [Essack 2013]. These inappropriate antibiotic prescriptions are a major driver for the development of antibiotic resistant bacteria, which has a number of negative implications; including the inability to treat common infections, resulting in prolonged illness and hospital stays and increased risk of death [WHO 2014].

GRIP opinion
GRIP members are of the opinion that local antibiotics such as fusafungine are not an appropriate treatment option for URTIs, due to the high risk of promoting antimicrobial resistance and their potential to disrupt the body’s natural microbiome. Any treatment using antibiotics should be a balanced evidenced-based decision made by a healthcare professional (HCP).

The withdrawal of fusafungine conveys an appropriate message to patients and HCPs around the rational use of antibiotics. Further HCP and patient education is essential to facilitate discussions around suitable and effective treatments. There is a specific need to educate patients on the ingredients of products and the role of symptomatic relief in treating URTIs.

References:

1. European Medicines Agency. Press Release. 2016.
2. Essack S, et al. Int J Clin Pract Suppl. 2013; (180):4–9.
3. Francis NA, et al. BMJ. 2009;339: b2885.
4. Spinks A, et al. Cochrane Database Syst Rev. 2006.
5. World Health Organisation. Antimicrobial resistance: Global report on surveillance. 2014.
6. Worrall GJ, et al. Can Fam Phys. 2007;53:666-671.