🔬 MHRA Finds No Causal Link Between GLP-1 Receptor Agonists and Suicidal or Self-Injurious Behavior Following a comprehensive review, the Medicines and Healthcare products Regulatory Agency (MHRA) has concluded that current evidence does not support a link between Glucagon-Like Peptide-1 (GLP-1) receptor agonists (such as exenatide, liraglutide, dulaglutide, and semaglutide) and suicidal thoughts, self-injury, or depression. This assessment follows an earlier safety review initiated in July 2023 after concerns were raised from post-marketing reports. After analyzing clinical trial data, epidemiological studies, and scientific literature, the MHRA’s findings align with European regulatory reviews, confirming no updates to product information are required at this time. 💡 Key Points: Available data does not establish a causal link between GLP-1 receptor agonists and severe psychiatric reactions. Ongoing monitoring of these medicines will continue to ensure patient safety. The MHRA remains committed to evaluating new data as it emerges. Ensuring patient safety is always a priority, and the MHRA will continue its vigilance in assessing any new risks associated with these widely-used treatments. Full information: https://lnkd.in/etuEzkGQ #Pharmaceuticals #PatientSafety #MHRA #GLP1ReceptorAgonists #Healthcare #RegulatoryAffairs #MedicalResearch #DrugSafety #Pharma
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🔬 MHRA Finds No Causal Link Between GLP-1 Receptor Agonists and Suicidal or Self-Injurious Behavior Following a comprehensive review, the Medicines and Healthcare products Regulatory Agency (MHRA) has concluded that current evidence does not support a link between Glucagon-Like Peptide-1 (GLP-1) receptor agonists (such as exenatide, liraglutide, dulaglutide, and semaglutide) and suicidal thoughts, self-injury, or depression. This assessment follows an earlier safety review initiated in July 2023 after concerns were raised from post-marketing reports. After analyzing clinical trial data, epidemiological studies, and scientific literature, the MHRA’s findings align with European regulatory reviews, confirming no updates to product information are required at this time. 💡 Key Points: Available data does not establish a causal link between GLP-1 receptor agonists and severe psychiatric reactions. Ongoing monitoring of these medicines will continue to ensure patient safety. The MHRA remains committed to evaluating new data as it emerges. Ensuring patient safety is always a priority, and the MHRA will continue its vigilance in assessing any new risks associated with these widely-used treatments. Full information: https://lnkd.in/etuEzkGQ #Pharmaceuticals #PatientSafety #MHRA #GLP1ReceptorAgonists #Healthcare #RegulatoryAffairs #MedicalResearch #DrugSafety #Pharma
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🔬 MHRA Finds No Causal Link Between GLP-1 Receptor Agonists and Suicidal or Self-Injurious Behavior Following a comprehensive review, the Medicines and Healthcare products Regulatory Agency (MHRA) has concluded that current evidence does not support a link between Glucagon-Like Peptide-1 (GLP-1) receptor agonists (such as exenatide, liraglutide, dulaglutide, and semaglutide) and suicidal thoughts, self-injury, or depression. This assessment follows an earlier safety review initiated in July 2023 after concerns were raised from post-marketing reports. After analyzing clinical trial data, epidemiological studies, and scientific literature, the MHRA’s findings align with European regulatory reviews, confirming no updates to product information are required at this time. 💡 Key Points: Available data does not establish a causal link between GLP-1 receptor agonists and severe psychiatric reactions. Ongoing monitoring of these medicines will continue to ensure patient safety. The MHRA remains committed to evaluating new data as it emerges. Ensuring patient safety is always a priority, and the MHRA will continue its vigilance in assessing any new risks associated with these widely-used treatments. Full information: https://lnkd.in/etuEzkGQ #Pharmaceuticals #PatientSafety #MHRA #GLP1ReceptorAgonists #Healthcare #RegulatoryAffairs #MedicalResearch #DrugSafety #Pharma
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Monthly Drug Safety 💊 Beta- lockers (Metoprolol, Propranolol ,Atenolol) Beta-blockers (Metoprolol, Propranolol, Atenolol) Metoprolol: For the treatment of essential hypertension in adults, functional heart disorders, migraine prophylaxis, cardiac arrhythmias, prevention of cardiac death and reinfarction after the acute phase of myocardial infarction, stable symptomatic CHF and angina pectoris. Propranolol: For the treatment of cardiac arrhythmias; tachycardia; hypertrophic obstructive cardiac myopathy; pheochromocytoma; thrombosis; management of angina; essential and renal hypertension; prophylaxis of migraine. Atenolol: For the treatment of hypertension, angina pectoris, cardiac arrhythmias. Adverse effect: Hypokalaemia Instagram - https://lnkd.in/g8UNzqQH Telegram - https://lnkd.in/gRKuMHft WhatsApp - https://lnkd.in/gp9Q77k2 #PHARMACY #DRUG #PHARMACOPOEIA #SAFETY #ADR
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🚨🚨Important Guidance on Compounded GLP-1 and Dual GIP/GLP-1 RA Therapies🚨🚨 📰 The American Diabetes Association (ADA) has issued a statement regarding the use of compounded GLP-1 receptor agonists (GLP-1 RAs) and dual GIP/GLP-1 RAs due to growing safety and efficacy concerns. 🔑 Key Points: 1️⃣ Avoid non-FDA-approved compounded products: These are not recommended due to uncertainty around safety, quality, and effectiveness. 2️⃣ Switch to FDA-approved alternatives during shortages: If FDA-approved medications are unavailable, alternative FDA-approved options within or outside the therapeutic class are recommended. 3️⃣ Reassess after shortages: Once shortages resolve, healthcare professionals should evaluate whether people should resume the original medication or continue with alternatives. 4️⃣ Exercise caution with compounded products: If compounded products are unavoidable, ensure they are obtained from credible sources and administered with proper guidance. 5️⃣ Be vigilant about counterfeit products: Counterfeit medications pose significant risks and must be avoided. Verify the source carefully. 6️⃣ Report adverse events: Any issues with non-FDA-approved compounded products should be reported to the FDA’s MedWatch program. For more details, access the full statement here: 👉🏼👉🏼 https://lnkd.in/e3z3ZKPN The ADA remains committed to safeguarding the health of people with diabetes and obesity through the promotion of evidence-based, safe, and effective care. #DiabetesCare #ObesityCare #MedicationSafety #Healthcare
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Important to review.
🚨🚨Important Guidance on Compounded GLP-1 and Dual GIP/GLP-1 RA Therapies🚨🚨 📰 The American Diabetes Association (ADA) has issued a statement regarding the use of compounded GLP-1 receptor agonists (GLP-1 RAs) and dual GIP/GLP-1 RAs due to growing safety and efficacy concerns. 🔑 Key Points: 1️⃣ Avoid non-FDA-approved compounded products: These are not recommended due to uncertainty around safety, quality, and effectiveness. 2️⃣ Switch to FDA-approved alternatives during shortages: If FDA-approved medications are unavailable, alternative FDA-approved options within or outside the therapeutic class are recommended. 3️⃣ Reassess after shortages: Once shortages resolve, healthcare professionals should evaluate whether people should resume the original medication or continue with alternatives. 4️⃣ Exercise caution with compounded products: If compounded products are unavoidable, ensure they are obtained from credible sources and administered with proper guidance. 5️⃣ Be vigilant about counterfeit products: Counterfeit medications pose significant risks and must be avoided. Verify the source carefully. 6️⃣ Report adverse events: Any issues with non-FDA-approved compounded products should be reported to the FDA’s MedWatch program. For more details, access the full statement here: 👉🏼👉🏼 https://lnkd.in/e3z3ZKPN The ADA remains committed to safeguarding the health of people with diabetes and obesity through the promotion of evidence-based, safe, and effective care. #DiabetesCare #ObesityCare #MedicationSafety #Healthcare
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Common diabetes drug may help slow organ aging, monkey study shows Metformin, a drug traditionally used to treat type 2 diabetes, has garnered significant attention for its potential anti-aging effects. Its mechanism involves improving insulin sensitivity, reducing inflammation and promoting cellular repair processes, all important factors in aging. In this new research, experts have discovered that administering the diabetes drug metformin to cynomolgus monkeys can slow aging across multiple organs, including the brain. Cynomolgus monkeys (Macaca fascicularis) are a suitable model for aging studies because, their physiological and functional characteristics resemble those of humans. Metformin may have significant impact on brain All the monkeys experienced a reduction in age-related decline, with some showing brain age indicators resembling those of monkeys six years younger. #drugsafety #diabetes #study #adr #metformin #preclinicaltrials #Fdc #mohf #pharmacovigilance #clinicalresearch #pharma #recentstudy #drugs #medicine
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Here's another article on #diabetic #drugs and weight loss. Source: Forbes - Jul 23, 2024 From the article: "There are seven approved GLP-1 drugs in the U.S. There’s also a similar class of medications called dual GLP-1 and GIP receptor agonists, and #tirzepatide (the generic name for #Mounjaro and #Zepbound) is the only drug available in the U.S. from this group. However, only #semaglutide, #liraglutide—the generic name for #Saxenda and #Victoza—and #tirzepatide have been approved by the Food and Drug Administration for weight management. Saxenda was the first to be approved in 2014, followed by #Wegovy in 2020 and Zepbound in 2023." #Diabites #Ozempic #Trulicity #Dulaglutide #WeightLoss https://lnkd.in/gJVHbz_k
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It is seen as part of a broader trend toward developing more convenient oral medications for weight loss and diabetes management, a highly competitive market with several other oral GLP-1 candidates under development. Orforglipron is an experimental oral GLP-1 receptor agonist developed by Eli Lilly, aimed at managing obesity and type 2 diabetes. Unlike injectable GLP-1 therapies such as semaglutide (Ozempic/Wegovy) or tirzepatide (Mounjaro), orforglipron is a daily oral medication. It has shown promising results in clinical trials, achieving significant weight loss and glycemic control. Revolutionizing diabetes and weight loss treatments! From Liraglutide to the latest promising therapies like Retatrutide and Orforglipron, these groundbreaking solutions are changing lives. #diabetes #glp #glp1 #obesity #liraglutide #semaglutide #tirzepatide #retatrutide #Orforglipron #fda #drug #elililly #Ozempic #Wegovy #Mounjaro
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Novo Nordisk's Ozempic has a new indication. To reduce the risk of kidney complications in adults with type 2 diabetes and chronic kidney disease. It will be interesting to see if this indication will eventually apply to Wegovy. The same drug, but a different product, indicated for weight loss. Indication expansion for GLP-1 drugs, combined with results from companies like Veru Inc. trying to preserve muscle mass that comes with the weight loss, could lead to a larger total addressable market for this class of medications https://lnkd.in/gXpMxqmh
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Innovent Biologics’s Phase III trial of type 2 diabetes treatment meets endpoints Innovent Clinical Development vice-president Dr Lei Qian said: “The results of DREAMS-1 provided high-quality, compelling evidence for T2D treatment in China, particularly in previously untreated patients whose blood glucose was inadequately controlled with diet and exercise alone. The results of another Phase III study DREAMS-2, involving patients with T2D inadequately controlled by oral antidiabetic drugs (OADs), met the study endpoints in May 2024. Together, the two studies demonstrate mazdutide’s comprehensive efficacy in improving glycemic control, promoting weight loss, and enhancing metabolic outcomes in patients with T2D.” - https://lnkd.in/d5MUESkA #clinicaltrials #diabetes
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