EMLA

EMLA ointment is a local anesthetic.

The combination of lidocaine with the anesthetic prilocaine in a ratio of 1:1 creates an eutectic mixture (“Eutectic Mixture of Local Anesthetic”, EMLA) which is liquid at skin temperature and has good penetration into the skin.

History

Before the specification of the approval in 2013, EMLA ointment was often used in the so-called off-label use in neonatal circumcision. In addition, EMLA ointment does not require a prescription and can therefore be purchased over the counter. As a result, a medical risk assessment for off-label use is not guaranteed. Even less can it be assumed that the partly non-physician group of people who use EMLA® ointment for newborn circumcision recognizes the symptoms of toxic drug levels in the newborn, let alone masters them.

In June 2013, the use of EMLA® ointment in neonatal circumcision was deemed “ethically unacceptable” by the CMDh group at the EMA. Since the risk assessment of the CMDh group did not take into account the risk potential from the foreseeable overdose in newborn circumcision, a reassessment was requested there. At the same time, on October 7, 2013, an application was made to the BfArM for EMLA® ointment to be subject to a prescription. To date (2020), the manufacturer advertises that the product is available in pharmacies without a prescription.

Various studies come to the conclusion that EMLA-circumcisions of young children are not suitable to sufficiently exclude the pain.

In the circumcision debate

The Legal Committee of the German Bundestag also met in 2012 on the so-called German Circumcision Act. There Prof. Dr. Reinhard Merkel on the subject of EMLA ointment:

“

There is a major Australian research report from May this year that examines all available studies and comes to the conclusion: EMLA is not suitable for the circumcision of young children to adequately exclude pain. [...] And it also suggests me to point out once again that the most comprehensive medical meta-study, a research report of the latest kind and international provenance, says the application from EMLA is not enough. It is, as the Australians put it, patently insufficient. – Prof. Dr. Reinhard Merkel (German Bundestag, 17th electoral term, Legal Affairs Committee (6th Committee), Minutes No. 74 of the 102nd session)

In the book The Circumcision of Boys published by Prof. Matthias Franz in 2013, he refers to information from the BfArm:

“	The effect of the EMLA® ointment, which is often used to reduce the pain of circumcision, is insufficient and was never approved for this purpose in Germany. – Manfred Will, 2013; personal communication after research at the BfArM (Franz M. Die Beschneidung von Jungen: Ein trauriges Vermächtnis)

Not approved for circumcision in newborns

In July 2013, the German Federal Institute for Drugs and Medical Devices (BfArM) revoked the indication of the anesthetic ointment EMLA for circumcision of newborns. EMLA has never had an approval for newborn circumcision, as the BfArM confirmed on March 7, 2013 to a medical member of Beschneidungsforum.de. The never-existing approval is evident from the technical information and instructions for use for EMLA and the drug law. The indications are under 4.1 of a technical and user information. Newborn circumcision was never performed there in Germany.

The German manufacturer of the EMLA ointment now confirms (at the latest since 2018) in the leaflet:

“

The efficacy of EMLA in heel phlebotomy in neonates or in providing adequate analgesia during circumcision has not been confirmed in clinical trials. [...] Do not use EMLA on the following skin areas: Cuts, abrasions or wounds other than leg ulcers. in areas with a rash or eczema. on or near the eyes. in the nose, ear or mouth. in the anal region (anus). on the genitals of children. – Aspen Germany GmbH (Package leaflet EMLA cream, approval no.: 42850.00.00)

Legal consequences

The German Circumcision Act of 2012 implemented a so-called Mohel clause in paragraph 2, which states that up to the end of the sixth month of life, a boy can also be circumcised by a non-medical practitioner, as long as he is "trained" for this form of genital mutilation. The Circumcision Debate of that time impressively proves that Jewish Mohels and other Jewish advocates of circumcision for boys repeatedly referred to the EMLA ointment as an adequate pain treatment.

The clear definition now available, that EMLA ointment may not be used at all in this case, leads at least paragraph 2 of the German Circumcision Act ad absurdum. It should be even easier for the German Federal Constitutional Court, once it has to decide on the constitutionality of § 1631d BGB, to put an end to this "fault of the rule of law".