Difference between revisions of "EMLA"
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| − | '''EMLA''' | + | '''EMLA''' is an acronym for Eutectic Mixture of Local Anesthetic.<ref>{{REFweb |
| + | |url=https://medical-dictionary.thefreedictionary.com/EMLA | ||
| + | |title=EMLA | ||
| + | |last=Anonymous | ||
| + | |first= | ||
| + | |init= | ||
| + | |publisher=The Free Dictionary by Farlex. | ||
| + | |date=2008 | ||
| + | |accessdate=2023-11-30 | ||
| + | }}</ref> EMLA Cream is a trademarked brand of topical local anesthetic. ''Eutectic'' means that the melting point of the combination is less than that of the ingredients.<ref>{{REFweb | ||
| + | |url=https://en.wikipedia.org/wiki/Eutectic_system | ||
| + | |title=Eutectic system | ||
| + | |last= | ||
| + | |first= | ||
| + | |init= | ||
| + | |publisher=Wiipedia | ||
| + | |date= | ||
| + | |accessdate=2023-11-30 | ||
| + | }}</ref> | ||
| − | The combination of lidocaine | + | The combination of the topical anestheics lidocaine and 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.<ref>{{REFweb |
|url=https://en.wikipedia.org/wiki/Lidocaine#Local_numbing_agent | |url=https://en.wikipedia.org/wiki/Lidocaine#Local_numbing_agent | ||
|title=Lidocaine #Local numbing agent | |title=Lidocaine #Local numbing agent | ||
|website=Wikipedia | |website=Wikipedia | ||
|accessdate=2022-07-27 | |accessdate=2022-07-27 | ||
| + | }}</ref> EMLA Cream is used to numb local areas of skin.<ref>{{REFweb | ||
| + | |url=https://www.drugs.com/emla.html | ||
| + | |title=Emla Cream | ||
| + | |last= | ||
| + | |first= | ||
| + | |init= | ||
| + | |publisher=Drugs.com | ||
| + | |date= | ||
| + | |accessdate=2023-11-30 | ||
}}</ref> | }}</ref> | ||
== History == | == History == | ||
| − | Before the specification of the approval in 2013, | + | Lander et al. (1997) did a comparison study of EMLA® cream topical anesthetic.<ref>{{REFweb |
| + | |url=https://medical-dictionary.thefreedictionary.com/Emla+cream | ||
| + | |title=Emla cream | ||
| + | |last=Anonymous | ||
| + | |publisher=The Free Dictionary by Farley | ||
| + | |date=2005 | ||
| + | |accessdate=2023-11-24 | ||
| + | }}</ref> EMLA® was the least-effective of the three analgesia methods studied.<ref name="lander1997">{{LanderJ etal 1997}}</ref> | ||
| + | |||
| + | Before the specification of the approval in 2013, EMLA® ointment was often used in the so-called ''off-label use''<ref>{{REFweb | ||
|url=https://en.wikipedia.org/wiki/Off-label_use | |url=https://en.wikipedia.org/wiki/Off-label_use | ||
|title=Off-Label use | |title=Off-Label use | ||
|website=Wikipedia | |website=Wikipedia | ||
|accessdate=2022-07-27 | |accessdate=2022-07-27 | ||
| − | }}</ref> in neonatal circumcision. In addition, | + | }}</ref> 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.<ref name="Wakankar 2014-02-18">{{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=27504#post27504 | |url=https://www.beschneidungsforum.de/thread/2353-buchver%C3%B6ffentlichung-mit-einem-beitrag-von-j%C3%A9r%C3%B4me-segal-herausgeber-prof-matthia/?postID=27504#post27504 | ||
|title=Die Beschneidung von Jungen, ein trauriges Vermächtnis | |title=Die Beschneidung von Jungen, ein trauriges Vermächtnis | ||
| Line 25: | Line 61: | ||
}}</ref> | }}</ref> | ||
| − | In June 2013, the use of EMLA® ointment in neonatal circumcision was deemed “ethically unacceptable” by the CMDh group at the EMA.<ref>{{REFweb | + | In June 2013, the use of EMLA® ointment in neonatal [[circumcision]] was deemed “ethically unacceptable” by the CMDh group at the EMA.<ref>{{REFweb |
|url=http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_45_work-sharing/Lidocaine_2013_07_45_PdAR.pdf | |url=http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_45_work-sharing/Lidocaine_2013_07_45_PdAR.pdf | ||
|title=Public Assessment Report for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No1901/2006, as amended Cathejell Lidocaine, Dynexan, EMLA, Jelliproct, Orofar, Strepsil lus, Xylestesin-A, Xylonor (Lidocaine) | |title=Public Assessment Report for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No1901/2006, as amended Cathejell Lidocaine, Dynexan, EMLA, Jelliproct, Orofar, Strepsil lus, Xylestesin-A, Xylonor (Lidocaine) | ||
| Line 41: | Line 77: | ||
}}</ref> | }}</ref> | ||
| − | + | The conclusion of various studies show that the effectiveness of EMLA® is not sufficient to exclude the [[pain]] of non-therapeutic infant [[circumcision]].<ref name="lander1997" /> <ref>{{REFjournal | |
|title=Does topical Amethocaine cream increase first-Time successful cannulation in children compared with a eutectic mixture of local anaesthetics (EMLA) cream? A systematic review and meta-analysis of randomised controlled trials | |title=Does topical Amethocaine cream increase first-Time successful cannulation in children compared with a eutectic mixture of local anaesthetics (EMLA) cream? A systematic review and meta-analysis of randomised controlled trials | ||
|url=https://www.researchgate.net/publication/267728942 | |url=https://www.researchgate.net/publication/267728942 | ||
| Line 57: | Line 93: | ||
|DOI=10.1136/emermed-2014-204066 | |DOI=10.1136/emermed-2014-204066 | ||
|accessdate=2020-12-19 | |accessdate=2020-12-19 | ||
| − | }}</ref><ref>{{REFjournal | + | }}</ref> <ref>{{REFjournal |
|url=https://pubmed.ncbi.nlm.nih.gov/30587535/ | |url=https://pubmed.ncbi.nlm.nih.gov/30587535/ | ||
|title=Efficacy and Safety of EMLA Cream for Pain Control Due to Venipuncture in Infants: A Meta-analysis | |title=Efficacy and Safety of EMLA Cream for Pain Control Due to Venipuncture in Infants: A Meta-analysis | ||
| Line 110: | Line 146: | ||
== 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 | ||
| Line 126: | Line 162: | ||
|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 | ||
| Line 137: | Line 173: | ||
}}</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 | ||
| Line 143: | Line 179: | ||
[...] | [...] | ||
| − | '''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. | ||
| Line 162: | Line 198: | ||
=== 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 | ||
| Line 175: | Line 211: | ||
|accessdate=2020-12-21 | |accessdate=2020-12-21 | ||
}}</ref> | }}</ref> | ||
| + | |||
{{SEEALSO}} | {{SEEALSO}} | ||
* [[Pain]] | * [[Pain]] | ||
| Line 180: | Line 217: | ||
{{REF}} | {{REF}} | ||
| + | [[Category:Acronym]] | ||
[[Category:Medicine]] | [[Category:Medicine]] | ||
[[Category:Circumcision product]] | [[Category:Circumcision product]] | ||
| − | + | [[Category:Pain]] | |
[[de:EMLA]] | [[de:EMLA]] | ||
Latest revision as of 11:19, 9 March 2024
EMLA is an acronym for Eutectic Mixture of Local Anesthetic.[1] EMLA Cream is a trademarked brand of topical local anesthetic. Eutectic means that the melting point of the combination is less than that of the ingredients.[2]
The combination of the topical anestheics lidocaine and 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.[3] EMLA Cream is used to numb local areas of skin.[4]
Contents
History
Lander et al. (1997) did a comparison study of EMLA® cream topical anesthetic.[5] EMLA® was the least-effective of the three analgesia methods studied.[6]
Before the specification of the approval in 2013, EMLA® ointment was often used in the so-called off-label use[7] 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.[8]
In June 2013, the use of EMLA® ointment in neonatal circumcision was deemed “ethically unacceptable” by the CMDh group at the EMA.[9] 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.[8] To date (2020), the manufacturer advertises that the product is available in pharmacies without a prescription.[10]
The conclusion of various studies show that the effectiveness of EMLA® is not sufficient to exclude the pain of non-therapeutic infant circumcision.[6] [11] [12]
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)[13] |
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.[14][15][16] 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.[17]
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:
|
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".[19]
See also
References
- ↑
Anonymous (2008). EMLA
, The Free Dictionary by Farlex.. Retrieved 30 November 2023. - ↑
Eutectic system
, Wiipedia. Retrieved 30 November 2023. - ↑
Lidocaine #Local numbing agent
, Wikipedia. Retrieved 27 July 2022. - ↑
Emla Cream
, Drugs.com. Retrieved 30 November 2023. - ↑ Anonymous (2005).
Emla cream
, The Free Dictionary by Farley. Retrieved 24 November 2023. - ↑ a b
Lander J, Brady-Frerer B, Metcalfe JB, Nazerali S, Muttit S. Comparison of ring block, dorsal penile nerve block, and topical anesthesia for neonatal circumcision. JAMA. 24 December 1997; 278(24): 2157-64. PMID. Retrieved 24 November 2023.
- ↑
Off-Label use
, Wikipedia. Retrieved 27 July 2022. - ↑ a b Wakankar (18 February 2014).
Die Beschneidung von Jungen, ein trauriges Vermächtnis
[The circumcision of boys, a sad legacy] (German), beschneidungsforum.de. Retrieved 19 December 2020. - ↑ (24 June 2013).
Public Assessment Report for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No1901/2006, as amended Cathejell Lidocaine, Dynexan, EMLA, Jelliproct, Orofar, Strepsil lus, Xylestesin-A, Xylonor (Lidocaine)
. Retrieved 19 December 2020.
- ↑
EMLA vor Tätowierungen
[EMLA before tattoos] (German), emla.de. Retrieved 19 December 2020. - ↑ Pywell A, Xyrichis A. Does topical Amethocaine cream increase first-Time successful cannulation in children compared with a eutectic mixture of local anaesthetics (EMLA) cream? A systematic review and meta-analysis of randomised controlled trials. Emerg Med J. September 2015; 32(9): 733-7. DOI. Retrieved 19 December 2020.
- ↑ Shahid S, Florez ID, Mbuagbaw L. Efficacy and Safety of EMLA Cream for Pain Control Due to Venipuncture in Infants: A Meta-analysis. Pediatrics. January 2019; 143(1): e20181173. PMID. DOI. Retrieved 19 December 2020.
- ↑
Franz M (2013): Die Beschneidung von Jungen: Ein trauriges Vermächtnis. [The circumcision of boys: A sad legacy] (German). Franz M. (ed.). Vandenhoeck & Ruprecht. Retrieved 21 December 2012.
Note: p. 12 (footnote 1) - ↑
Zirkumzision #Schmerzen und postoperative Beschwerden
[Circumcision #Pain and postoperative discomfort], Wikipedia (German). Retrieved 19 December 2020. - ↑ Drug information from the German federal and state governments - Changes to the instructions for use and specialist information from July 22, 2013 - Available at pharmnet-bund.de
- ↑ Schulte von Drach, Markus C. (19 August 2013).
Beschneidung von Neugeborenen - Fragwürdige Betäubung
[Newborn circumcision - questionable anesthetic] (German), sueddeutsche.de. Retrieved 9 February 2015. - ↑ Wakankar (19 February 2014).
Die Beschneidung von Jungen, ein trauriges Vermächtnis
[The circumcision of boys, a sad legacy] (German), beschneidungsforum.de. Retrieved 19 December 2020. - ↑
Packungsbeilage zum Download - Emla Creme & Emla Pflaster
[Downloadable leaflet - Emla Cream & Emla Patch] (German), emla.de. Retrieved 19 December 2020. - ↑
Käfer, Armin (22 August 2012)."Interview zur Beschneidung Sonderrechte sind ein Sündenfall
" [Interview on circumcisionSpecial rights are a sin
] (German), StZ. Retrieved 21 December 2020.
