EMLA: Difference between revisions
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== Not approved for circumcision in newborns == | == 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 | 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.<ref>{{REFweb | ||
|url=https://de.wikipedia.org/wiki/Zirkumzision#Schmerzen_und_postoperative_Beschwerden | |url=https://de.wikipedia.org/wiki/Zirkumzision#Schmerzen_und_postoperative_Beschwerden | ||
|title=Zirkumzision #Schmerzen und postoperative Beschwerden | |title=Zirkumzision #Schmerzen und postoperative Beschwerden | ||
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|date=2013-08-19 | |date=2013-08-19 | ||
|accessdate=2015-02-09 | |accessdate=2015-02-09 | ||
}}</ref> | }}</ref> 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.<ref name="Wakankar 2014-02-19">{{REFweb | ||
|url=https://www.beschneidungsforum.de/thread/2353-buchver%C3%B6ffentlichung-mit-einem-beitrag-von-j%C3%A9r%C3%B4me-segal-herausgeber-prof-matthia/?postID=27541#post27541 | |url=https://www.beschneidungsforum.de/thread/2353-buchver%C3%B6ffentlichung-mit-einem-beitrag-von-j%C3%A9r%C3%B4me-segal-herausgeber-prof-matthia/?postID=27541#post27541 | ||
|title=Die Beschneidung von Jungen, ein trauriges Vermächtnis | |title=Die Beschneidung von Jungen, ein trauriges Vermächtnis | ||
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}}</ref> | }}</ref> | ||
The German manufacturer of the | The German manufacturer of the EMLA® ointment now confirms (at the latest since 2018) in the leaflet: | ||
{{Citation | {{Citation | ||
|Author=Aspen Germany GmbH | |Author=Aspen Germany GmbH | ||
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[...] | [...] | ||
'''Do not use | '''Do not use EMLA® on the following skin areas:''' | ||
* Cuts, abrasions or wounds other than leg ulcers. | * Cuts, abrasions or wounds other than leg ulcers. | ||
* in areas with a rash or eczema. | * in areas with a rash or eczema. | ||
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=== Legal consequences === | === 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 [[Mohel]]s and other Jewish advocates of [[circumcision]] for boys repeatedly referred to the | 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 [[Mohel]]s 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".<ref>{{REFnews | 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".<ref>{{REFnews | ||