Ahmed Elgouhary, MD’s Post

🚨🚨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

Important to review.

FDA has approved the 1st generic Liraglutide injection (18 mg/3 ml), which can be opted as a new option for managing Type 2 Diabetes in patients 10 years and older. This is a GLP-1 receptor agonist which has been designed to improve glycemic control along with good diet and exercise that has been supported by studies showing its effectiveness in lowering blood sugar and improving diabetes management. Liraglutide mimics the GLP-1 activity in the body which further helps to regulate blood pressure. During the clinical trials, it was found out that prescribing this requires careful considerations because its usage is associated with potential risks including thyroid C-cell tumors and pancreatitis and patients having such specific medical histories should avoid the drug. Also there are other side effects including nausea, diarrhea and anorexia. As there is a shortage of GLP-1 medications, this generic approval is a critical step towards addressing the issue of T2D in adults. @pharmacy times.

Exciting News in Diabetes Treatment! 🎉 The FDA has approved the first generic once-daily GLP-1 injection to help lower blood sugar levels in adults with Type 2 Diabetes. This approval represents a significant step forward in increasing accessibility and affordability for patients managing this chronic condition. Key Highlights: ▶️ What is GLP-1? A glucagon-like peptide-1 receptor agonist that helps regulate blood sugar levels effectively. ▶️ Why it matters: This generic option provides a cost-effective alternative for patients, potentially improving treatment access for many. ▶️ FDA's commitment: Ensures high standards of safety, efficacy, and affordability in diabetes care. 🌟 This milestone reinforces the importance of advancing healthcare through innovation and accessibility. Follow Cornerstone Clinical Research Services for more industry insights, updates, and advancements in clinical research. #FDAApproval #GenericDrugs #DiabetesManagement #ClinicalResearch #HealthcareInnovation #GLP1 #DiabetesCare #IndustryInsights #CCRS

🔬 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

🔬 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

🔬 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

𝐍𝐞𝐰 𝐢𝐧𝐬𝐮𝐥𝐢𝐧 𝐝𝐞𝐥𝐢𝐯𝐞𝐫𝐞𝐝 𝐨𝐧𝐜𝐞 𝐚 𝐰𝐞𝐞𝐤 𝐡𝐚𝐬 𝐝𝐞𝐦𝐨𝐧𝐬𝐭𝐫𝐚𝐭𝐞𝐝 𝐞𝐟𝐟𝐢𝐜𝐚𝐜𝐲 At the annual meeting of the European Association for the Study of Diabetes e.V. (EASD) 2024 in Madrid, the results of clinical trials of the new insulin efsitor, which is administered once a week, were presented. The tests showed that the new drug is as effective as degludec, which is administered daily. The trials were conducted in the format of evaluating the new insulin compared to the existing insulin. The established limit of non-inferior efficacy was 0.4 percentage units of HbA1c, confirming the comparability of efsitora and degludec in lowering blood sugar levels. The 52-week QWINT-2 study enrolled 928 patients with type 2 diabetes who were not previously taking insulin. Participants were randomly assigned into groups to receive either efsitora or degludec. Results showed that HbA1c levels decreased from 6.97% to 6.97% when receiving efsitora and from 8.24% to 7.05% when receiving degludec. The time participants spent in the target blood sugar range was 64.3% for efsitora and 61.2% for degludec. The frequency of hypoglycemia was significantly lower: no cases of severe hypoglycemia were recorded when taking efsitora, while 6 cases were registered when using degludec. According to the authors of the development, further study of the drug dosage in patients with type 1 diabetes is required. #archtown #medicine #easd

The latest in the evolving once-weekly insulin icodec story was an unexpected one for me. An FDA advisory panel last week collectively considered the potential adverse effects of insulin icodec to outweigh the potential benefits specifically in people with type 1 diabetes. The concern seems to relate largely to the risk of hypoglycaemia with some on the panel advocating for further trials to better quantify the risk and more importantly, determine how this risk can be best mitigated. The panel member comments are interesting, they seem keen for more therapeutic options in type 1 diabetes, as are we all, but do not want to see choice come at the cost of increased risk, especially if the increased financial cost to patients doesn't come with sufficient benefit for them. #T1D #insulin https://lnkd.in/gPJH5Rxr

Combining Aspirin and Vascepa: Is There a Recommended Dosage?Aspirin and Vascepa are two medications commonly prescribed to patients with cardiovascular conditions. While they are often used together, it's essential to understand the recommended dosage and potential interactions between the two drugs. In this article, we'll delve into the world of aspirin and Vascepa, exploring their individual benefits,... https://lnkd.in/eaqkN6rp