Bufexamac

Structural formula
General
Non-proprietary name	Bufexamac
other names	4-butoxy N -hydroxyphenylacetamid
Molecular formula	C 12 H 17 NO 3
External identifiers / databases
EC number	219-451-1
ECHA InfoCard	100.017.683
PubChem	2466
ChemSpider	2372
Wikidata	Q412699
Drug information
ATC code	M01 AB17 ; M02 AA09 ;
Drug class	Anti-inflammatory drugs
properties
Molar mass	223.27 g mol −1
safety instructions
	Please note the exemption from the labeling requirement for drugs, medical devices, cosmetics, food and animal feed
GHS labeling of hazardous substances	no GHS pictograms
	no GHS pictograms
H and P phrases	H: no H-phrases
	P: no P-phrases
Toxicological data	3370 mg kg −1 ( LD 50 , rat , oral )
	As far as possible and customary, SI units are used. Unless otherwise noted, the data given apply to standard conditions .

Bufexamac is an anti-inflammatory ( antiphlogistic ) effective drug for the topical treatment of the skin.

Because of the unfavorable benefit-risk ratio (see section side effects ), Bufexamac-containing medicinal products are no longer to be used and are not or no longer on the market in many EU member states.

application

Bufexamac has been used for dermatitis . It has an anti-inflammatory and antipruritic effect. Preparations containing bufexamac were used for acute and chronic eczema and locally as a combination preparation together with lidocaine as a suppository for hemorrhoidal diseases. The substance has also been used to treat atopic eczema , minor burns , sunburn and itching . In the subacute inflammatory phase, the active ingredient represented a substitute for cortisone . However, reactions and allergies to the active ingredient can also occur, which is why the drug commission of the German medical profession had critically questioned its use for years in more than ten articles and reports since 2000.

Working principle

It is assumed that bufexamac, like indomethacin, intervenes in prostaglandin synthesis by inhibiting cyclooxygenases . The scientific data on this are scanty, however.

Side effects

The active ingredient Bufexamac was known to cause even strong allergic contact eczema, which was often mistakenly mistaken for the original symptom. Therefore, the use should be carefully considered as early as 2000. The Arznei-Telegram had already submitted an “application for risk prevention measures for Bufexamac” to the Federal Health Office responsible at the time on July 10, 1987 . In 2009 the Federal Institute for Drugs and Medical Devices (BfArM) held a hearing on drugs containing bufexamac in all indications according to the step-by-step plan , level II. "The BfArM [...] comes to the conclusion that, according to the current state of scientific knowledge and taking into account available therapeutic alternatives, Bufexamac-containing drugs have harmful effects both in eczema therapy and in proctological indications, which, according to the findings of the medical science go beyond reasonable limits. The benefit / harm ratio is thus judged to be negative overall. ” In April 2010, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) also decided on a negative benefit-risk ratio and withdrawal due to the high risk of triggering contact eczema the Food and drug bufexamac-containing medicines recommended. As a result, the BfArM revoked the approvals; Medicines containing bufexamac could therefore no longer be dispensed in Germany from May 5, 2010.