The European Medicines Agency is currently investigating the potential depressive effects and behavioural changes associated with the use of medicines containing liraglutide and semaglutide in patients seeking weight loss treatment.
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| Ozempic, injectable anti-obesity drug |
In a groundbreaking development, a new generation of drugs has emerged, initially intended for diabetes management, but now revolutionising the field of obesity treatment. While these weight loss methods have proven to be highly effective, experts caution against viewing them as miraculous solutions due to potential side effects.
The drugs in question are part of the GLP-1 receptor agonists family, specifically designed to address the growing prevalence of type 2 diabetes. This disease has experienced a significant surge in recent decades, paralleling the global rise in obesity rates.
In the realm of GLP-1 receptor agonists, two notable medications have emerged: tirzepatide, commercially known as Mounjaro™, and semaglutide, available as injections under the names Ozempic™ and Wegovy™. These medications have received the stamp of approval from the US Food and Drug Administration (FDA).
In a groundbreaking development, it has been revealed that up until this point, the only medication authorised for patients suffering from type 2 diabetes in Argentina was Ozempic™. In a groundbreaking development, sources from the esteemed National Administration of Medicines, Food and Medical Technology (ANMAT) have recently disclosed that Wegovy™ has been granted official authorization in the country for its remarkable efficacy in combating obesity. The injectable solution is conveniently packaged in prefilled pens. The medication is administered on a weekly basis through subcutaneous injection, targeting the abdomen, thigh, or upper arm.
Not only do these drugs effectively regulate blood sugar levels, but they also have the added benefit of promoting weight loss. In their inaugural year of utilisation, these groundbreaking treatments have demonstrated the ability to assist patients in shedding over 10% of their total body weight. In their mechanism of action, these substances emulate the effects of a hormone known as glucagon-like peptide-1 (GLP-1), thereby impeding the process of digestion and curbing one’s appetite.
In a concerning development, patients consuming these drugs have encountered problems in recent months, coinciding with the increasing popularity of their marketing campaigns. Not only is it associated with gastric or bodily disorders, but it is also intricately connected to mental health. Several patients have come forward, sharing their experiences of battling symptoms such as depression, anguish, persistent sadness, and noticeable mood fluctuations.
The safety committee of the European Medicines Agency (EMA) and the Pharmacovigilance Risk Assessment Committee (PRAC) are currently conducting a thorough review of data pertaining to the potential risk of suicidal thoughts and self-harm among patients who are prescribed certain medications. In a groundbreaking development, researchers have identified a new class of drugs known as agonists of the GLP-1 receptor.
Iceland’s medicines agency has launched a review in response to numerous complaints lodged by individuals who have been prescribed the medications liraglutide and semaglutide. Authorities have reportedly obtained and are currently scrutinising approximately 150 accounts of potential instances of self-harm and contemplation of suicide.
The connection between the reported cases and the medications in question, as well as the potential influence of patients’ underlying conditions or other factors, remains a subject of ongoing uncertainty among experts. In a meticulous examination conducted under the purview of a signal procedure, the review is undertaken.
In the arena of pharmaceuticals, a signal serves as a crucial piece of information that highlights a potential occurrence of an adverse event linked to a specific drug. It can also shed light on previously unknown aspects of an already recognised adverse event, thereby necessitating a deeper exploration and examination.
In line with standard medical practise, it is strongly recommended that both patients and healthcare professionals adhere to the prescribed guidelines when using GLP-1 receptor agonists. In an effort to ensure the safety and well-being of patients, it is imperative that both healthcare professionals and patients themselves promptly report any potential side effects to the appropriate authorities.
This crucial step plays a vital role in the ongoing monitoring and evaluation of medical treatments and medications. By actively engaging in this reporting process, individuals can contribute to the collective effort of safeguarding public health and promoting transparency within the healthcare system. According to the European Medicines Agency (EMA), individuals can find guidance on reporting suspected side effects in the leaflets and on the websites of national medicines authorities.
The FDA, at present, has not initiated any investigations into this matter and is currently focused on closely monitoring patients. However, it is worth noting that the FDA has received a total of 489 reports through its adverse event reporting system, detailing instances where patients have encountered anxiety, depression, or suicidal thoughts while under medication.
In a groundbreaking development, researchers have made significant strides in the field of medicine with the use of semaglutide. Out of the total number of reports, a staggering 96 cases revealed that the patients had experienced thoughts of self-harm. Tragically, five individuals lost their lives. The causal link between these weight loss drugs and mental health problems remains uncertain.
According to a statement made by FDA spokesperson Chanapa Tantibanchachai, it is reiterated that the advantages of these medications surpass any potential drawbacks when utilised in accordance with the FDA-approved guidelines. However, Tantibanchachai clarified that Wegovy™, a weight-loss medication that shares the active ingredient semaglutide with Ozempic™, does carry a cautionary note regarding the possibility of experiencing suicidal thoughts, as indicated on its label.
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| Wegovy™, weight loss drug |
In a recent interview with Infobae, Dr. Carla Musso, the esteemed coordinator of the Diabetes department at the renowned Favaloro Foundation, shed light on the importance of a comprehensive approach to diabetes treatment.
According to Dr. Musso, the administration of medication must be accompanied by significant modifications in dietary habits, engagement in physical activity, and the provision of psychological support. According to the expert, who took part in a controlled trial of semaglutide, individuals who are overweight or obese require psychological support in order to modify their lifestyle habits and break free from a sedentary way of life.
Problems with clinical trial
During the clinical trials conducted prior to the marketing authorization of these weight loss medications, potential mental problems that could be caused or exacerbated by these drugs were not documented. Incidents of this nature are typically rare occurrences during the course of drug clinical trials, primarily due to the relatively small sample size of patients involved and the limited duration of the studies. Once a drug has been introduced to the market, it has the potential to be consumed by millions of patients over an extended period of time.
However, a significant constraint of pre-approval studies lies in the selection criteria for participants. In a recent statement, Dr. Amy Rothberg, a distinguished endocrinologist hailing from the esteemed University of Michigan, shed light on the meticulous process undertaken during the recruitment of patients for clinical trials involving Ozempic™. According to Dr. Rothberg, these potential participants were subjected to a comprehensive screening procedure, which included assessments for depression, anxiety, and even suicidal ideation. Individuals who were found to have these conditions would have been disqualified from participating.
In the field of clinical practise, the situation may not unfold exactly as anticipated. According to an expert, individuals diagnosed with major depressive disorder and undergoing treatment may experience an elevated vulnerability to heightened anxiety or depression due to certain medications. This aspect, unfortunately, tends to be overlooked. In a recent interview, the individual in question, known as “the expert,” shared their insights on the matter at hand.
Novo Nordisk’s spokesperson, Allison Scheider, represents the renowned laboratory responsible for the production of Ozempic™. In response to the recent reports of new side effects, the company’s representative emphasised their unwavering commitment to addressing these concerns. However, it is worth noting that this particular class of drugs has been in use for over 15 years.
In an ongoing effort to prioritise patient safety and provide healthcare professionals with accurate information, pharmaceutical company Novo Nordisk has been diligently monitoring data from both clinical trials and real-world usage of its products. The company has also been working closely with authorities to ensure that all necessary precautions are taken.
Despite any potential concerns, Novo Nordisk maintains a strong belief in the risk-benefit profile of its products. The company remains committed to upholding patient safety as a top priority, as emphasised by a spokesperson who stated, “Novo Nordisk remains confident in the risk-benefit profile of the products and remains committed to ensuring patient safety.”
According to the official website of Ozempic™, the drug is associated with several prevalent side effects. These commonly reported adverse reactions include nausea, stomach pain, constipation, diarrhoea, and vomiting. In a statement provided by Novo Nordisk, the pharmaceutical company emphasised that the drugs in question “belong to a widely recognised category of medications that have undergone extensive clinical trials, thereby establishing their long-term safety.” According to experts, it has been observed that the gastrointestinal system is prone to experiencing adverse reactions, which are commonly associated with GLP-1.
Dr. Meera Shah, an esteemed endocrinologist at the renowned Mayo Clinic, has officially endorsed this finding. According to her professional expertise, the prevailing side effect observed in patients is none other than nausea, closely followed by abdominal pain, constipation, and diarrhoea. According to the expert, there is a possibility that these side effects may show signs of improvement over time. However, it is worth noting that a minimum of 10% of patients who initiate these medications are compelled to discontinue their usage due to the lack of improvement in the side effects.
Constant nausea and abdominal pain have become an unfortunate reality for many individuals. The intricate relationship between the stomach and brain is well-documented, with intestinal issues having the potential to trigger feelings of stress, anxiety, and even depression. This phenomenon, commonly referred to as the “gut-brain connection,” highlights the profound interplay between these two vital organs.
Source: Victor Ingrassia/Infobae.