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Annals of Clinical and Medical
Case Reports
Review Article ISSN 2639-8109 Volume 12
Buttigieg GG1*
and Micallef-Stafrace K2
1
University of Malta/University of Rome, Tor Vergata/ Plovdiv Medical University, Malta
2
Consultant Sports and Exercise Medicine, Mater Dei Hospital, Malta
The EMA and Glucagon-Like Peptide-1 Agonists: A Wake-Up Call
*
Corresponding author:
George Gregory Buttigieg,
University of Malta/University of Rome, Tor
Vergata/ Plovdiv Medical University, The Glen,
Russett Street, Kappara, San Gwann, SGN4432,
Malta
Received: 10 Nov 2023
Accepted: 19 Dec 2023
Published: 27 Dec 2023
J Short Name: ACMCR
Copyright:
©2023 Buttigieg GG. This is an open access article
distributed under the terms of the Creative Commons
Attribution License, which permits unrestricted use, dis-
tribution, and build upon your work non-commercially
Citation:
Buttigieg GG, The EMA and Glucagon-Like Peptide-1
Agonists: A Wake-Up Call. Ann Clin Med Case Rep.
2023; V12(6): 1-3
United Prime Publications LLC., https://acmcasereport.org/ 1
Keywords:
European Medicines Authority (EMA); Glucagon-like
Peptide-1 (GLP-1) Agonists; Complications; Semaglu-
tide (Ozempic); Self-harm; Weight loss; Complications;
Off-label; Elephant in the room
1. Abstract
The European MedicinesAuthority (EMA) is a decentralised agen-
cy of the European Union (EU) responsible for the scientific eval-
uation, supervision and safety monitoring of medicines in the EU
and the European economic Area (EEA). On July 11th
, 2023, it is-
sued a press release stating that PRAC (The EMA’s safety commit-
tee) was reviewing data on the potential risk of suicidal thoughts
and thoughts of self-harm with medicines known as GLP-1 recep-
tor agonists, including Ozempic (semaglutide), Saxenda (liraglu-
tide) and Wegovy (semaglutide). This was in response to reports
by the Icelandic Medicines Authority of patients on liraglutide and
semaglutide experiencing suicidal tendencies and thoughts of self-
harm. Such reported signals are rightly taken very seriously by
the EMA. However, looking at Ozempic, one is stricken by the
EU’s Medicine’s Authority lack of publicly highlighting warnings
in view of three burning issues. Firstly, the rampant, rarely seen
meteoric use of the drug, which is becoming a seeming status sym-
bol for use in weight loss and is openly promulgated as such by
media and movie moguls as such. Secondly, the fact that the use
of Ozempic in weight-loss is off-label. And thirdly, thirdly the es-
tablished number of still-increasing, serious complications which
carry serious health risks and even a risk to life in the face of this
orgiastic misuse of a GLP-1 receptor agonist.
2. The European Medicines Agency
The European Medicines Agency (EMA) does an invaluable job
of safeguarding and promoting both human and animal health by
constantly evaluating medical products within the European Un-
ion (EU) and the European Economic Area (EEA). The Agency
has had its fair share of criticism regarding its stipulated mission
statement. Some of these attacks include the quality of its clin-
ical trial reports (e.g. Barbui et al 2011) [1], its closeness to the
industry (e.g. Grattini 2016) [2], the protection of drug compa-
ny profits above patient welfare by withholding access to the data
(e.g. Tzsche et al.,) [3]. However much criticised, the Agency is
indispensable and has repeatedly obtained European Court re-af-
firmation of its purported standing. Thus, in PTC Therapeutics In-
ternational v EMA [4] and MSD Animal Health Innovation v EMA
[5], the European Court has unambiguously upheld the EMA’s ap-
proach to transparency, confirming the right of citizens for access
to clinical study and toxicology reports submitted to the EMA for
the purpose of the granting of a marketing authorisation for human
and veterinary medicinal products.
3. Glucagon-Like Peptide 1 (GLP-1) Agonists
Glucagon-like-peptide 1(GLP-1) is a gut-derived peptide hormone
which lowers blood glucose through the stimulation of insulin se-
cretion from the pancreas. Its action is mimicked by these synthetic
United Prime Publications LLC., https://acmcasereport.org/ 2
Volume 12 Issue 6 -2023 Review Article
agonists and this class of medications are utilized in the treatment
of type 2 diabetes mellitus and obesity. Examples of these drugs
include Ozempic (semaglutide), Saxenda (liraglutide) and We-
govy (semaglutide). While liraglutide (Saxenda) is indicated for
physician-oriented weight-loss programmes, semaglutide (Ozem-
pic) is indicated as part of Type II diabetes mellitus. Ozempic is
not intended for weight loss and any such use is, off-label.
Ozempic has been cleared for use in type 2 diabetes mellitus, pe-
riod. The EMA specifically states that Ozempic should be used in
the treatment of adults with insufficiently controlled type 2 diabe-
tes mellitus as an adjunct to diet and exercise, either as monothera-
py when metformin is considered inappropriate due to intolerance
or contraindications or in addition to other medicinal products.
Semaglutide as Wegovy is approved for weight loss but not as
Ozempic, although semaglutide is present in both products, albeit
in different doses.
4. A Game Changer’
According to the EMA, -liraglutide and semaglutide are extremely
widely used and to-date (11/07/2023) there are over 20 million pa-
tient- years [6], defining one patient-year as the equivalent of one
patient taking a medicine for one year. Ozempic is Novo-Nordisk
leading drug and its sales growth for 2023 is forecasted at 23%
with sales of $12.5bn [7]. The surge in the sales of the GLP-1
drugs is the topic of conversation in every (healthcare) trade organ-
ization today, the product being repeatedly referred to as a game
changer. We speak here of a stock market game changer with long-
term ripple effects across equities and economy [8]. The off-label
use of Ozempic for weight loss has even led to a shortage in the
medication for what it was intended for, namely type -2 diabetes
mellitus management. This phenomenon is worldwide. For exam-
ple, in Australia, Novo Nordisk has advised that very limited new
supplies of Ozempic 0.25/0.5mg would be available before the end
of 2023 and there would be intermittent supply of all strengths of
Ozempic for the rest of 2023 and throughout 20241
. In view of this
shortage the FDA has warned against the use of fraudulent and
unapproved products including compounded varieties [9]. Such a
warning would not have been out of place if also issued by the
EMA as fraudulent and unapproved variants of Ozempic in the
thirst for a miracle weight-losing drug are also riding the wave
within the European Union and the European Economic Area. And
among the one powerful catalysts in this worrying process is the
media. In British Columbia, the Health Ministry is officially in-
vestigating the relationship between the almost 10 per cent use of
Ozempic prescriptions for weight loss and the contributory influ-
ence of social media on the matter [10].
5. Potentially Fatal Side-Effects
The use of pharmacological agents on an off-line basis is well
known in the medical world, in circumstances some of which are
more justifiable than other. However, the phenomenon needs to
be re-visited when applied to a drug, the off- label use of which
constitutes up to about 10% of consumption, and which has prov-
en and potentially devastating and even fatal side-effects. We live
in a culture where patient autonomy seems to be extra-polated to
prescribing all that the patient wants and demands. This is ques-
tionable at best and at times, outright unethical and potentially
illegal. For although patients, dreaming of dramatic weight loss
may put up with abdominal pain, constipation, diarrhoea, nausea
and vomiting, the situation may be different if any of the major po-
tential side-effects supervene. These include hypoglycaemia, acute
gallbladder disease, acute renal damage, anaphylaxis, retinopathy,
thyroid tumours and pancreatitis. The reportage of potentially se-
rious complications is a work in progress. Thus, on 28 September
2023, the FDA reported 2 deaths from ileus and warned about po-
tential Ozempic- induced paralytic ileus. 2 Another 2023 publica-
tion, warns of potential life-threatening stomach content regurgita-
tion and pulmonary aspiration in cases of surgery in the presence
of Ozempic [11]. The drug works by decreasing appetite both
through suppression of the brain’s hunger centres as well as by
slowing gastric emptying. It is the latter effect which is considered
as posing a surgical threat, especially, but not only, in emergency
cases where possibly a sufficiently long period of starvation may
not have been observed in a patient on Ozempic.
6. Conclusion
In accordance with its self-declared transparency, the EMA was
correct in recently revealing the Icelandic Drug Authority signals
relating to self-harm and stating that an investigation was to be
launched. If the connection is confirmed, then, obviously a new
major potential complication is added to Ozempic official compli-
cations. This is particularly important especially when considering
the increased risk of depression, suicidal ideation and suicidal at-
tempts in diabetics [12], as well as the high rates of suicide idea-
tion and/or behaviour in the severely obese [13].
However, we also firmly believe that the occasion of the Icelandic
signal reportage is an opportune occasion to wake up, see the ele-
phant in the room and respond accordingly. In an age which is hell-
bent on physique, the off-label use of a “miracle weight-reducing
drug” fostered by the media, screen personalities and certain med-
ical practitioners, (particularly in certain specialties e.g. plastic
surgery) is not easy to control. Yet, the EMA is uniquely poised to
issue the right directives to medical practitioners as well as suit-
able press-releases to the general public concerning the current
distorted status quo of Ozempic. This applies both to its irrational
and increasing off-label use as well as to its complications, the list
of which does not seem to be complete. The EMA must clearly
warn the public that drugs are licensed for use in specific situations
and carry certain potential serious and possibly fatal complication
risks. The present indiscriminate abuse of Ozempic must be cur-
tailed by a multi-front approach and it is one where the powerful
EMA honouring its stated mission statement, must take the lead.
United Prime Publications LLC., https://acmcasereport.org/ 3
Volume 12 Issue 6 -2023 Review Article
References
1. Barbui C, Baschirotto C, Cipriani A. EMA must improve the quality
of its clinical trial reports BMJ. 2011; 342: d2291.
2. Garattini S. The European Medicines Agency is still too close to
industry BMJ. 2016; 353: i2412.
3. Gøtzsche PC, Jørgensen AW. Opening up data at the European Med-
icines Agency BMJ. 2011; 342: d2686.
4. ECLI:EU:C:2020:23.Case C-175/18 P:PTC Therapeutics Interna-
tional v EMA.
5. ECLI:EU:C:2020:24. Case C-178/18 P: MSD Animal Health Inno-
vation and Intervet international v EMA.
6. One patient-year is the equivalent of one patient taking a medicine
for one year.
7. Novo Nordisk blockbuster Ozempic boasts 23% sales surge in 2023.
Global Data Healthcare. April 28, 2023.
8. Fox M. The stock market is getting Ozempic’ed. Markets Insider.
2023.
9. Medications Containing. Semaglutide Marketed for Type 2 Diabetes
or Weight Loss. 2023.
10. Hager M. Social-media spikes demand for diabetes drug: Province
says 10% of ozempic prescriptions filled by americans amid demand
for off-label weight loss use. The Globe and Mail. 2023.
11. Beam WB, Lindsay R. Guevara H. Are Serious Anesthesia Risks of
Semaglutide and Other GLP-1 Agonists Under-Recognized? Case
Reports of Retained Solid Gastric Contents in Patients Undergoing
Anesthesia. The Official Journal of the Anaesthesia Patient Safety
Foundation. 2023; 69-73.
12. Elamoshy R, Bird Y, Thorpe L, Moraros J. Risk of Depression and
Suicidality among Diabetic Patients: A Systematic Review and Me-
ta-Analysis. J. Clin Med. 2018; 7: 445.
13. Chen EY, Fettich KC, Kierney M, Cummings H, Berona J, Weissman
J, et al. Factors Associated with Suicide Ideation in Severely Obese
Bariatric Surgery- Seeking Individuals.” Suicide & Life-threatening
Behaviour. 2012; 42(5): 541-49.

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The EMA and Glucagon-Like Peptide-1 Agonists: A Wake-Up Call

  • 1. Annals of Clinical and Medical Case Reports Review Article ISSN 2639-8109 Volume 12 Buttigieg GG1* and Micallef-Stafrace K2 1 University of Malta/University of Rome, Tor Vergata/ Plovdiv Medical University, Malta 2 Consultant Sports and Exercise Medicine, Mater Dei Hospital, Malta The EMA and Glucagon-Like Peptide-1 Agonists: A Wake-Up Call * Corresponding author: George Gregory Buttigieg, University of Malta/University of Rome, Tor Vergata/ Plovdiv Medical University, The Glen, Russett Street, Kappara, San Gwann, SGN4432, Malta Received: 10 Nov 2023 Accepted: 19 Dec 2023 Published: 27 Dec 2023 J Short Name: ACMCR Copyright: ©2023 Buttigieg GG. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, dis- tribution, and build upon your work non-commercially Citation: Buttigieg GG, The EMA and Glucagon-Like Peptide-1 Agonists: A Wake-Up Call. Ann Clin Med Case Rep. 2023; V12(6): 1-3 United Prime Publications LLC., https://acmcasereport.org/ 1 Keywords: European Medicines Authority (EMA); Glucagon-like Peptide-1 (GLP-1) Agonists; Complications; Semaglu- tide (Ozempic); Self-harm; Weight loss; Complications; Off-label; Elephant in the room 1. Abstract The European MedicinesAuthority (EMA) is a decentralised agen- cy of the European Union (EU) responsible for the scientific eval- uation, supervision and safety monitoring of medicines in the EU and the European economic Area (EEA). On July 11th , 2023, it is- sued a press release stating that PRAC (The EMA’s safety commit- tee) was reviewing data on the potential risk of suicidal thoughts and thoughts of self-harm with medicines known as GLP-1 recep- tor agonists, including Ozempic (semaglutide), Saxenda (liraglu- tide) and Wegovy (semaglutide). This was in response to reports by the Icelandic Medicines Authority of patients on liraglutide and semaglutide experiencing suicidal tendencies and thoughts of self- harm. Such reported signals are rightly taken very seriously by the EMA. However, looking at Ozempic, one is stricken by the EU’s Medicine’s Authority lack of publicly highlighting warnings in view of three burning issues. Firstly, the rampant, rarely seen meteoric use of the drug, which is becoming a seeming status sym- bol for use in weight loss and is openly promulgated as such by media and movie moguls as such. Secondly, the fact that the use of Ozempic in weight-loss is off-label. And thirdly, thirdly the es- tablished number of still-increasing, serious complications which carry serious health risks and even a risk to life in the face of this orgiastic misuse of a GLP-1 receptor agonist. 2. The European Medicines Agency The European Medicines Agency (EMA) does an invaluable job of safeguarding and promoting both human and animal health by constantly evaluating medical products within the European Un- ion (EU) and the European Economic Area (EEA). The Agency has had its fair share of criticism regarding its stipulated mission statement. Some of these attacks include the quality of its clin- ical trial reports (e.g. Barbui et al 2011) [1], its closeness to the industry (e.g. Grattini 2016) [2], the protection of drug compa- ny profits above patient welfare by withholding access to the data (e.g. Tzsche et al.,) [3]. However much criticised, the Agency is indispensable and has repeatedly obtained European Court re-af- firmation of its purported standing. Thus, in PTC Therapeutics In- ternational v EMA [4] and MSD Animal Health Innovation v EMA [5], the European Court has unambiguously upheld the EMA’s ap- proach to transparency, confirming the right of citizens for access to clinical study and toxicology reports submitted to the EMA for the purpose of the granting of a marketing authorisation for human and veterinary medicinal products. 3. Glucagon-Like Peptide 1 (GLP-1) Agonists Glucagon-like-peptide 1(GLP-1) is a gut-derived peptide hormone which lowers blood glucose through the stimulation of insulin se- cretion from the pancreas. Its action is mimicked by these synthetic
  • 2. United Prime Publications LLC., https://acmcasereport.org/ 2 Volume 12 Issue 6 -2023 Review Article agonists and this class of medications are utilized in the treatment of type 2 diabetes mellitus and obesity. Examples of these drugs include Ozempic (semaglutide), Saxenda (liraglutide) and We- govy (semaglutide). While liraglutide (Saxenda) is indicated for physician-oriented weight-loss programmes, semaglutide (Ozem- pic) is indicated as part of Type II diabetes mellitus. Ozempic is not intended for weight loss and any such use is, off-label. Ozempic has been cleared for use in type 2 diabetes mellitus, pe- riod. The EMA specifically states that Ozempic should be used in the treatment of adults with insufficiently controlled type 2 diabe- tes mellitus as an adjunct to diet and exercise, either as monothera- py when metformin is considered inappropriate due to intolerance or contraindications or in addition to other medicinal products. Semaglutide as Wegovy is approved for weight loss but not as Ozempic, although semaglutide is present in both products, albeit in different doses. 4. A Game Changer’ According to the EMA, -liraglutide and semaglutide are extremely widely used and to-date (11/07/2023) there are over 20 million pa- tient- years [6], defining one patient-year as the equivalent of one patient taking a medicine for one year. Ozempic is Novo-Nordisk leading drug and its sales growth for 2023 is forecasted at 23% with sales of $12.5bn [7]. The surge in the sales of the GLP-1 drugs is the topic of conversation in every (healthcare) trade organ- ization today, the product being repeatedly referred to as a game changer. We speak here of a stock market game changer with long- term ripple effects across equities and economy [8]. The off-label use of Ozempic for weight loss has even led to a shortage in the medication for what it was intended for, namely type -2 diabetes mellitus management. This phenomenon is worldwide. For exam- ple, in Australia, Novo Nordisk has advised that very limited new supplies of Ozempic 0.25/0.5mg would be available before the end of 2023 and there would be intermittent supply of all strengths of Ozempic for the rest of 2023 and throughout 20241 . In view of this shortage the FDA has warned against the use of fraudulent and unapproved products including compounded varieties [9]. Such a warning would not have been out of place if also issued by the EMA as fraudulent and unapproved variants of Ozempic in the thirst for a miracle weight-losing drug are also riding the wave within the European Union and the European Economic Area. And among the one powerful catalysts in this worrying process is the media. In British Columbia, the Health Ministry is officially in- vestigating the relationship between the almost 10 per cent use of Ozempic prescriptions for weight loss and the contributory influ- ence of social media on the matter [10]. 5. Potentially Fatal Side-Effects The use of pharmacological agents on an off-line basis is well known in the medical world, in circumstances some of which are more justifiable than other. However, the phenomenon needs to be re-visited when applied to a drug, the off- label use of which constitutes up to about 10% of consumption, and which has prov- en and potentially devastating and even fatal side-effects. We live in a culture where patient autonomy seems to be extra-polated to prescribing all that the patient wants and demands. This is ques- tionable at best and at times, outright unethical and potentially illegal. For although patients, dreaming of dramatic weight loss may put up with abdominal pain, constipation, diarrhoea, nausea and vomiting, the situation may be different if any of the major po- tential side-effects supervene. These include hypoglycaemia, acute gallbladder disease, acute renal damage, anaphylaxis, retinopathy, thyroid tumours and pancreatitis. The reportage of potentially se- rious complications is a work in progress. Thus, on 28 September 2023, the FDA reported 2 deaths from ileus and warned about po- tential Ozempic- induced paralytic ileus. 2 Another 2023 publica- tion, warns of potential life-threatening stomach content regurgita- tion and pulmonary aspiration in cases of surgery in the presence of Ozempic [11]. The drug works by decreasing appetite both through suppression of the brain’s hunger centres as well as by slowing gastric emptying. It is the latter effect which is considered as posing a surgical threat, especially, but not only, in emergency cases where possibly a sufficiently long period of starvation may not have been observed in a patient on Ozempic. 6. Conclusion In accordance with its self-declared transparency, the EMA was correct in recently revealing the Icelandic Drug Authority signals relating to self-harm and stating that an investigation was to be launched. If the connection is confirmed, then, obviously a new major potential complication is added to Ozempic official compli- cations. This is particularly important especially when considering the increased risk of depression, suicidal ideation and suicidal at- tempts in diabetics [12], as well as the high rates of suicide idea- tion and/or behaviour in the severely obese [13]. However, we also firmly believe that the occasion of the Icelandic signal reportage is an opportune occasion to wake up, see the ele- phant in the room and respond accordingly. In an age which is hell- bent on physique, the off-label use of a “miracle weight-reducing drug” fostered by the media, screen personalities and certain med- ical practitioners, (particularly in certain specialties e.g. plastic surgery) is not easy to control. Yet, the EMA is uniquely poised to issue the right directives to medical practitioners as well as suit- able press-releases to the general public concerning the current distorted status quo of Ozempic. This applies both to its irrational and increasing off-label use as well as to its complications, the list of which does not seem to be complete. The EMA must clearly warn the public that drugs are licensed for use in specific situations and carry certain potential serious and possibly fatal complication risks. The present indiscriminate abuse of Ozempic must be cur- tailed by a multi-front approach and it is one where the powerful EMA honouring its stated mission statement, must take the lead.
  • 3. United Prime Publications LLC., https://acmcasereport.org/ 3 Volume 12 Issue 6 -2023 Review Article References 1. Barbui C, Baschirotto C, Cipriani A. EMA must improve the quality of its clinical trial reports BMJ. 2011; 342: d2291. 2. Garattini S. The European Medicines Agency is still too close to industry BMJ. 2016; 353: i2412. 3. Gøtzsche PC, Jørgensen AW. Opening up data at the European Med- icines Agency BMJ. 2011; 342: d2686. 4. ECLI:EU:C:2020:23.Case C-175/18 P:PTC Therapeutics Interna- tional v EMA. 5. ECLI:EU:C:2020:24. Case C-178/18 P: MSD Animal Health Inno- vation and Intervet international v EMA. 6. One patient-year is the equivalent of one patient taking a medicine for one year. 7. Novo Nordisk blockbuster Ozempic boasts 23% sales surge in 2023. Global Data Healthcare. April 28, 2023. 8. Fox M. The stock market is getting Ozempic’ed. Markets Insider. 2023. 9. Medications Containing. Semaglutide Marketed for Type 2 Diabetes or Weight Loss. 2023. 10. Hager M. Social-media spikes demand for diabetes drug: Province says 10% of ozempic prescriptions filled by americans amid demand for off-label weight loss use. The Globe and Mail. 2023. 11. Beam WB, Lindsay R. Guevara H. Are Serious Anesthesia Risks of Semaglutide and Other GLP-1 Agonists Under-Recognized? Case Reports of Retained Solid Gastric Contents in Patients Undergoing Anesthesia. The Official Journal of the Anaesthesia Patient Safety Foundation. 2023; 69-73. 12. Elamoshy R, Bird Y, Thorpe L, Moraros J. Risk of Depression and Suicidality among Diabetic Patients: A Systematic Review and Me- ta-Analysis. J. Clin Med. 2018; 7: 445. 13. Chen EY, Fettich KC, Kierney M, Cummings H, Berona J, Weissman J, et al. Factors Associated with Suicide Ideation in Severely Obese Bariatric Surgery- Seeking Individuals.” Suicide & Life-threatening Behaviour. 2012; 42(5): 541-49.