Ozempic's Impact On Brain Chemistry May Influence Depression Risk: Study
According to the research that was published in the journal Current Neuropharmacology, GLP-1 drugs may disrupt dopamine levels, potentially leading to depression and suicidal thoughts in individuals with low dopamine function. While these medications show promise in treating obesity and diabetes, further investigation is needed to understand their potential impact on mental health.
As per a news release, the study, led by researchers across the United States, Brazil, Iran, and Israel, demonstrates that while GLP1 agonists benefit individuals with hyperdopaminergia (excess dopamine activity), they may have harmful effects on individuals with hypodopaminergia (low dopamine function). The authors found genetic associations between GLP1 receptor agonists and genes such as DRD3, BDNF, and CREB1, which are implicated in mood regulation and reward pathways. Their findings suggest that chronic use of these drugs could dysregulate dopamine signalling, potentially leading to depressive symptoms, mood disturbances, and SI.
Cautionary Voices from Experts
While the idea of GLP-1 agonism induction of depression and SI is controversial with both negative and positive reporting, based on the evidence presented in this article by Alireza Sharafshah, a PhD candidate from the Cellular and Molecular Research Centre, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran, the authors caution against promoting chronic stimulation via GLP-1 agonists.
"This study should not be ignored, despite the hype surrounding the positive clinical outcomes of GLP-1 receptor agonists," said senior author Dr Kenneth Blum, research professor at Western University Health Sciences and Ariel University. "We urge the clinical prescribing community to proceed with caution to avoid another tragic wave of 'people dying to lose weight'."
Dr Mark S Gold, an addiction psychiatry pioneer and co-author, emphasised, "The paper provides critical evidence for re-evaluating the widespread use of GLP1 receptor agonists. The FDA and other regulatory agencies should carefully consider our findings when it comes to labelling and monitoring these drugs."
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Mint
3 hours ago
- Mint
Lawmakers Press FDA to Target Knockoff Weight-Loss Drugs
(Bloomberg) -- Dozens of lawmakers are urging US health regulators to crack down on the booming market for knockoff weight-loss drugs amid mounting concerns over their potential safety risks. On Friday, a group of more than 80 bipartisan lawmakers asked the US Food and Drug Administration to stop counterfeit and copycat versions of GLP-1 drugs like Wegovy and Zepbound from flooding the market — a problem that emerged over the last year. 'We are concerned about recent reports revealing a surge in illegal and counterfeit anti-obesity medications,' they wrote in a letter to FDA Commissioner Marty Makary. 'Undoubtedly, illegal counterfeit medications pose an increased risk to patient safety with sometimes fatal consequences.' The group — spearheaded by Representatives Richard Hudson of North Carolina and Herb Conaway of New Jersey — asked the agency to ramp up enforcement over illegally imported weight-loss drugs. They suggested issuing warning letters and better monitoring non-compliant online retailers and so-called compounding pharmacies that sell the medicines. The lawmakers also said the FDA should work in tandem with US Customs and Border Patrol agents to stop Chinese entities from shipping unsafe weight-loss drugs into the US. They requested an update on the FDA's efforts by July 30, given the 'urgency' of the situation. A spokesperson for the FDA said the agency will work with the US Department of Health and Human Services to provide a 'complete and thorough' response to the issues raised in the lawmakers' letter. 'Any effort to undermine America's supply of safe medicines is an issue that FDA takes seriously,' the spokesperson said. 'And we are deeply committed to strengthening the oversight of imported products at US ports of entry.' In recent years, the popularity of GLP-1 drugs has led to an explosion of copycats and counterfeits made by companies seeking to capitalize on the hype. State-licensed pharmacies were temporarily allowed to make copies of the drugs during a supply shortage, but are no longer permitted to do so after Novo Nordisk A/S and Eli Lilly & Co. boosted production. Still, some pharmacies have refused to wind down their operations while others have pivoted to selling the drugs in lower doses in order to avoid regulatory scrutiny. Counterfeit drugs are made by unregistered entities typically using illegally imported ingredients. As recently as April, there continue to be instances when counterfeit Ozempic pens covertly enter the drug supply chain undetected. Some patients are also purchasing ingredients directly from online sellers in an attempt to make the drugs themselves at home. In both cases, the medications don't go through the same rigorous approval process as brand-name drugs made by Novo and Lilly. Experts worry the lack of oversight is putting patients at risk. The FDA has said it's aware of hospitalizations potentially linked to the copycat drugs, but that adverse events are likely being underreported. 'We support the bi-partisan call for the FDA to crack down on counterfeit and illegally sold weight-loss drugs,' said a spokesperson for Hims & Hers Health Inc., one of the telehealth firms that sells compounded GLP-1s. 'We appreciate lawmakers' recognition that legitimate compounded medications dispensed by state-regulated pharmacies are not counterfeit. Patient safety must always come first.' Novo and Lilly have discouraged consumers from using compounded and counterfeit products, including suing telehealth firms that sell the copycat versions and working with border agents to seize illegal shipments. Under the Biden administration, the companies repeatedly urged the FDA to take action, but the agency mostly limited its actions to issuing consumer warnings — even as its top drug official publicly acknowledged safety concerns. Under the Trump administration, the HHS has also focused more heavily on other issues, such as banning food dyes and examining vaccine schedules. Meanwhile, lawmakers are ramping up their calls for action. State attorneys and other lawmakers have sent letters to the FDA and Federal Trade Commission advocating for greater transparency around the treatments and more scrutiny around marketing practices. (Updates with statement from FDA in sixth and seventh paragraphs.) More stories like this are available on
Mint
8 hours ago
- Mint
Manu Joseph: Why drugs that eat our hunger won't cause a revolution
Two drugs are generating the sort of cultural excitement that only Viagra once did. Like Viagra, their effects are visible, and often not attributed to the medicine. Semaglutide and Tirzepatide, known by their brand names Ozempic and Mounjaro, were designed to treat diabetes. But as often happens with iconic drugs, their fame lies in what they do on the side. They reduce appetite. So, people eat less and lose weight. Doctors are taking these drugs too, which is a good sign. Not that they are paragons of health, but they know how patients respond to the drugs and so it suggests they consider them safe. Meanwhile, society is bracing for a behavioural revolution. A certain leanness—a non-muscular kind in middle-aged people that I already associate with these drugs—might become another motif of wealth. At the moment, the drugs are for the affluent, but that can change over time. There is even a view that once these drugs go off patent and generics flood the market, they may hurt the restaurant business. Also Read: What body positivity means in the age of Ozempic I doubt that. I think their impact will be modest. People do not eat because they're hungry, especially the rich. Even most of the poor no longer eat out of necessity alone. Nobody eats maida noodles and biryani out of hunger. For most people, eating is a form of entertainment. Even a source of happiness. Many people can bear the period between meals because they know food is coming. Many keep eating through the day because people do a lot of what is fun. Also, food is the most legit drug addiction. Some years ago, Silicon Valley fell in love with a powdered food called Soylent. Just add water and drink. It was engineered to provide all the nutrients the body needs. As the product didn't ship to India, I found an Indian version of it. I carried packets everywhere. I was sorted, I felt. I liked the idea of just drinking food and being done with it. I had defeated an ancient cultural force that had entrapped me through what I always viewed as an obsolete mode of nutrition. There is nothing wrong with Soylent, but its revolution never took off. People realized that life, as we've built it, revolves around food. Meals are where we meet. Efficiency is not the point. In fact, if we are efficient at all, it is in matters other than food, so that we can lavish our time on food. At first glance, drugs that kill appetite may appear to be different from a tasteless drink that merely has everything the body needs. The drugs don't replace food. People would still eat tasty meals, even if they eat less. They would meet friends over meals, but leave most of it on their plates. At first, people will be alright with it. They are having it all, they might say. Tasty food, but in forced moderation. Eventually, though, they would have had enough of it. Also Read: Ozempic, a patent challenge, and the $25 billion race for India's weight-loss drug market Semaglutide and Tirzepatide cannot address the underlying reasons why people eat and overeat. Imagine a pill that makes you want to watch less TV. Let us assume it works. What is the alternative to not wasting time on boring entertainment, an oxymoron that is the reality of the times? Actually, there is something that makes you want to watch less TV, and that's TV itself. Yet, people have nothing better to do. It is the same with food. Without food, life is so dreary to most people that they will eat even if they don't feel like eating. This is something they already do, anyway. Here is what will happen. These drugs will make the fit fitter. People who already work towards health or beauty will be the true beneficiaries of this medical intervention. Others will do things like having only desserts for meals, arguing that they are going to have little to eat anyway. Eventually, they will find ways to malign these drugs. They will have exaggerated complaints about their side effects and romanticize 'natural' hunger. They will insist the body knows best. If it is asking for food, they will say, and if 'nature' is demanding food, then there must be some reason; how can we let 'chemicals' come in the way of natural appetite? Never underestimate the things sugar can make people do. The effectiveness of these drugs raises an interesting question: If suppressing appetite still leaves a person healthy, then is normal eating just a form of overeating? How much food does a person really need? Also Read: Mounjaro in India: The speed bumps impacting access to weight loss drugs Probably far less than what most people eat. Statistically, on any given day, we over-eat or under-eat because, outside of theory, balance is not a real thing. Under-eating has its own risks. Muscle growth, for example, needs protein beyond the reduced consumption these drugs would induce. Strong muscles aren't just about vanity, they help regulate metabolism and maintain our health. Also, when the body faces an energy deficit, it does not simply burn fat. It switches some things off. Based on its own logic and hierarchies, it starts conserving energy by cutting what it considers less important. Like one's immune response. Or skin quality. Or hair health. It adapts to scarcity by becoming stingy with its resources. The same could happen here. People may stay lean but become weak, metabolically and bodily. We may then have unfit people who look thin. We may not understand what's been lost either. That will take years to discover. Also Read: 'We shouldn't use Mounjaro as a way to get skinny': Dr Alexandra Sowa If some people believe they look good just by taking a drug, they may stop working out if they have never enjoyed it. That would be a disaster. Exercise doesn't just burn fat. It does things modern life does not give us. Our true health is not what we appear to be, but what the body knows it has gone through, what it knows it can endure. The author is a journalist, novelist, and the creator of the Netflix series, 'Decoupled'
The Hindu
9 hours ago
- The Hindu
Lenacapavir: After FDA approval, HIV pre-exposure prophylaxis injectable moving closer to EU approval
On July 25, The European Medicines Agency (EMA)'s advisory committee recommended Gilead Sciences' Lenacapavir, a twice-yearly injection, for preventing HIV infection in adults and adolescents. Any recommendation by EMA's advisory committee has to be formally approved by the European Commission, which is expected later this year. The recommendation by the EMA's advisory committee comes about a month after the U.S. FDA on June 18, 2025 approved the injectable HIV-1 capsid inhibitor as a pre-exposure prophylaxis (PrEP). The World Health Organization welcomed the approval by FDA on June 19 and issued guidelines for use of Lenacapavir for HIV prevention on July 14. 'Offering additional pre-exposure prophylaxis (PrEP) choices has the potential to increase uptake and effective use of PrEP, and of HIV prevention overall, as it allows people to choose a method that they prefer,' the guidelines say. Studies have also shown that Lenacapavir can achieve significant viral suppression, even in cases where other drugs have failed. The FDA approved Lenacapavir is based on the 2024 results from the PURPOSE 1 and PURPOSE 2 trials, which demonstrated the safety and efficacy of the pre-exposure prophylaxis injectable across diverse populations and settings. The PURPOSE 1 was a Phase 3, double-blind, randomised trial to evaluate the safety and efficacy of twice-yearly, subcutaneous Lenacapavir for pre-exposure prophylaxis (PrEP) and was tested on 5,338 cisgender women and adolescent girls aged 16-25 across 25 sites in South Africa and three sites in Uganda. The injectable was compared with an active control arm that received once-daily oral pre-exposure prophylaxis drug Truvada (emtricitabine-tenofovir disoproxil fumarate; F/TDF). There were zero HIV infections among 2,134 participants in the Lenacapavir group, while the active control group had 39 infections among 2,136 participants. In the PURPOSE 2 Phase-3 trial involving 3,265 participants in the modified intention-to-treat analysis, two participants were infected with HIV in the arm that received the injectable, while nine participants who received the active control PrEP oral drug Truvada (emtricitabine-tenofovir disoproxil fumarate; F/TDF) were infected. The background HIV incidence in the screened population (4,634 participants) was 2.37 per 100 person-years. The trial was carried out in of cisgender men, transgender, and nonbinary individuals across 88 sites in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the U.S. Compared with the generic PrEP oral drug Truvada, which is extremely inexpensive and widely available, Lenacapavir costs $28,000 for two injections. Why would people ever prefer to use Lenacapavir considering the cost? 'Oral PrEP will be effective only if there is 100% adherence. The oral drug won't work even if it is missed for a day because the drug level will be only 24 hours,' says Dr. N. Kumarasamy, Chief and Director, VHS-Infectious Diseases Medical Centre, Voluntary Health Services, Chennai. 'People who have the highest risk such as sex workers and gay men have to take the drug every day. Taking a tablet every day, even for a deceased patient, is so difficult. They tend to miss a dose, which is why adherence is never 100%,' he says. 'Even in the case of on-demand PrEP, where people who want to indulge in unprotected sex have to take the oral drug two days before, then throughout the period of risky behaviour and continue for two more days after risky behaviour ends, adherence never goes beyond 85-90%. PrEP will work only if the adherence is 100%.' According to Dr. Kumarasamy, despite the oral tablet being inexpensive and easy to take, the adherence is less than ideal, the reason why people are moving towards long-acting injectables that prevent HIV infection for months after an injection. Cabotegravir, which was developed as pre-exposure prophylaxis (PrEP), underwent trials in many countries and was approved for use. Cabotegravir, which is administered intramuscularly every two months, was found superior compared with every day oral PrEP tablet, and started getting implemented in certain parts of the world, Dr. Kumarasamy says. 'Since Cabotegravir has to be administered every two months, people tend to forget. The new drug Lanacapivir has been found to be effective for six months in the trials. The injectable was developed in 2021 as treatment in people who no longer respond to other drugs as they have developed resistance,' he says. Because Lenacapavir was found to be long-acting, it was repurposed as a pre-exposure prophylaxis administered subcutaneously. 'Lenacapavir is a robust molecule and is the best solution in the absence of vaccines. Even if there is going to be an HIV vaccine one day, I'm sure people will have to take the vaccine every year or something. Like a flu shot, you know if at all they are going to develop a vaccine, people may have to take it every year or every six months as a booster dose. It may not be like a one dose that is effective for years,' Dr. Kumarasamy says. 'In the absence of a HIV vaccine, I think the pre-exposure prophylaxis every six months can be considered like a vaccine.' Gilead is developing the same molecule to be administered once a year instead of every six months. They are already working on that. But it will not be a subcutaneous form but as an intramuscular injection, he says. Licensing agreements On October 2, 2024, Gilead Sciences signed non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical manufacturers to make and sell generic Lenacapavir. Of the six generic manufacturers, four are in India. Besides signing agreement to license generic manufacturers to make the injectable, Gilead Sciences also said that it would 'support low-cost access to the drug in high-incidence, resource-limited countries at no profit until generic manufacturers are able to fully support demand'. These countries are: Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia and Zimbabwe. The company has licensed Dr. Reddy's Laboratories Limited, Emcure, Hetero and Mylan, a subsidiary of Viatris, to manufacture Lenacapavir in India. The companies will be permitted to supply to 120 countries. According to the press release, the agreements cover not only Lenacapavir for HIV prevention but also for HIV treatment in heavily treatment-experienced (HTE) adults with multi-drug resistant HIV. According to Dr. Kumarasamy one company has already started developing the drug and Lenacapavir may become available next year once the Indian drug regulator approves it based on the results of a safety study carried out in India. As per his estimate, the generic form of Lenacapavir will cost about $100 per dose.
