Bufexamac preparations have been traditionally used to treat insect bites, stings, minor cuts, abrasions, sunburn, thermal burns and inflammatorydermatoses (such as dermatitis) [1,2]. However, there is scarce evidence substantiating its efficacy [3]. It has also been previously manufactured as a suppository for haemorrhoids (piles).
In which countries is bufexamac found?
Due to its adverse effects and establishment as a contact allergen, bufexamac is not available in the following countries as of August 2018 [1,4]:
New Zealand
Japan
European Union (including the United Kingdom)
United States
Canada.
As of 2020, it is no longer available in Australia. Bufexamac is still available over the counter in other countries.
What are the reactions to bufexamac?
Bufexamac has been established as a cause of allergic contact dermatitis [4]. It can also result in [1,5–11]:
An adverse reaction to bufexamac is diagnosed by taking a careful patient history, examining the rash, and patch testing.
An allergic reaction to bufexamac may appear similar to the condition for which bufexamac was being used, so reactions to bufexamac may be underreported.
A positive patch test
How is the adverse reaction to bufexamac treated?
The use of bufexamac should be stopped and it should be avoided in the long term.
Medsafe New Zealand. Consideration of bufexamac-containing medicines indicated for the relief of dermatitis, rash and hives under Section 36 of the Medicines Act 1981. Minutes of the 145th Medicines Adverse Reactions Committee Meeting — 10 March 2011. Available at: http://www.medsafe.govt.nz/profs/adverse/Minutes145.htm#3.1.1 (accessed August 2018).
MIMS Online. Pharmacy Action antiseptic cream. August 2018. Available at: www.mimsonline.com.au (accessed August 2018; login required).
Christiansen JV, Gadborg E, Kleiter I, et al. Efficacy of bufexamac (NFN) cream in skin diseases. A double-blind multicentre trial. Dermatologica 1977; 154: 177–84. PubMed
Uter W, Schnuch A. EMA revokes marketing authorization for bufexamac. Contact Dermatitis 2011; 64: 235–6. DOI: 10.1111/j.1600-0536.2011.01883.x. PubMed
Arikawa J, Okabe S, Kaneko T. Allergic contact dermatitis with spreading over extensive regions due to topical use of 5% bufexamac ointment. J Dermatol 2004; 31: 136–8. PubMed
Fukuda H, Sato Y, Usami N, Yokouchi Y, Mukai H. Contact dermatitis caused by bufexamac sparing the eruption of herpes zoster. J Dermatol 2012; 39: 405–7. DOI: 10.1111/j.1346-8138.2011.01261.x. PubMed
Koch P, Bahmer FA. Erythema-multiforme-like, urticarial papular and plaque eruptions from bufexamac: report of 4 cases. Contact Dermatitis 1994; 31: 97–101. PubMed
Kurumaji Y. Photo Koebner phenomenon in erythema-multiforme-like eruption induced by contact dermatitis due to bufexamac. Dermatology 1998; 197: 183–6. PubMed
Belhadjali H, Ghannouchi N, Nim L, et al. Acute generalized exanthematous pustulosis induced by bufexamac in an atopic girl. Contact Dermatitis 2008; 58: 247–8. DOI: 10.1111/j.1600-0536.2007.01271.x. PubMed
Waltermann K, Marsch W, Kreft B. [Bufexamac-induced pigmented purpuric eruption]. Hautarzt 2009; 60: 424–7. [Article in German] DOI: 10.1007/s00105-008-1656-2. PubMed
Proske S, Uter W, Schnuch A, Hartschuh W. [Severe allergic contact dermatitis with generalized spread due to bufexamac presenting as the "baboon" syndrome]. Dtsch Med Wochenschr 2003; 128: 545–7. [Article in German] DOI: 10.1055/s-2003-37850. PubMed