British doctors are urging caution regarding the weight-loss drug Tirzepatid (Mounjaro) after the death of a 58-year-old nursing assistant in Scotland.
Susan McGowan from North Lanarkshire obtained Tirzepatid online after researching the medication and consulting with a doctor. She administered small doses for approximately two weeks before her death.
Following her second injection, McGowan experienced severe stomach pain and nausea, leading her to the emergency room at Monklands Hospital, where she tragically died. A medical report attributed her death to multiple organ failure, septic shock, and pancreatitis, with Tirzepatid potentially playing a role.
A family member stated that McGowan, apart from mild obesity, was in good health and not taking any other medications.
Experts are cautiously analyzing this case. While tirzepatid has been linked to conditions like acute pancreatitis, Professor Amanda Adler, an expert in diabetes and health policy at the University of Oxford, emphasizes that patients can develop acute pancreatitis for various reasons.
Professor Naveed sattar, an endocrinologist at the University of Glasgow, pointed to clinical trials involving around 10,000 individuals with diabetes or obesity, which did not indicate a higher risk of pancreatitis related to Tirzepatid.
He stresses that current data suggests acceptable safety and several benefits, including meaningful weight loss, strong diabetes prevention, and considerable advantages for those with sleep apnea.
Tirzepatid, a GLP-1 receptor agonist, has received approval for weight management from both the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).
Common side effects reported by the EMA include nausea and diarrhea in over 10% of patients, and constipation and vomiting in up to 10%. These side effects are typically mild or moderate and often occur when the dosage is adjusted.The UK’s Yellow Card system, a voluntary drug-monitoring system, has recorded 208 adverse drug reactions related to Tirzepatid, including 31 serious reactions and one suspected death in a man in his 60s.
A spokesperson for the manufacturer, Eli Lilly, emphasized their commitment to continuously monitoring, evaluating, and reporting safety facts. They stated that Tirzepatid was approved based on a thorough assessment of benefits versus risks. They advocate open interaction between patients and healthcare providers regarding any potential side effects.
The National Health Service (NHS) in england is planning a phased rollout of Tirzepatid, prioritizing patients with the most significant clinical need.The initial phase targets individuals with a Body Mass Index (BMI) exceeding 40 who also suffer from at least three major weight-related health conditions: hypertension, dyslipidemia, obstructive sleep apnea, and cardiovascular diseases.
Dr. Alison Cave, Chief Safety Officer at the MHRA, expressed their condolences to the family and reaffirmed the agency’s unwavering priority on patient safety.
She highlighted that new medications like Tirzepatid undergo intensive monitoring to promptly identify any safety concerns. She urged doctors and the public to continue reporting any suspected reactions.
Dr.Cave stressed that the benefits of GLP-1 receptor agonists,like Tirzepatid,outweigh their potential risks when used for approved indications. She emphasized the importance of collaborative decision-making between patients and their doctors regarding treatment initiation, continuation, or discontinuation, factoring in a extensive evaluation of benefits and risks.
What are the potential side effects of Tirzepatid (Mounjaro) that patients should be aware of?
Interview: an Insight into the Safety of tirzepatid (Mounjaro) Post-Tragedy
Q: Thank you for joining us today, Professor Amanda Adler. Given the recent tragic case involving Susan McGowan and Tirzepatid, what are your initial thoughts on its safety?
A: Thank you for having me. ItS undoubtedly a heartbreaking situation. Cases like this highlight the complexities of medication use,especially in weight management. Tirzepatid does have associations with acute pancreatitis, but it’s crucial to remember that pancreatitis can occur due to a variety of factors. We need to take a cautious but balanced approach to patient safety.
Q: Professor Naveed Sattar, you mentioned in your previous communications that clinical trials did not show a higher risk of pancreatitis with Tirzepatid. Can you elaborate on this?
A: Absolutely. In the extensive clinical trials involving about 10,000 participants with diabetes or obesity, the data did not indicate increased pancreatitis risk compared to other treatments. While we need to be vigilant in monitoring adverse reactions post-market, the controlled environment of these trials provides us with a promising overview of Tirzepatid’s safety profile.
Q: With both the UK’s Medicines and Healthcare products regulatory Agency (MHRA) and the European Medicines Agency (EMA) approving Tirzepatid for weight management, what factors contributed to this?
A: The approval was based on thorough assessments demonstrating that Tirzepatid, a GLP-1 receptor agonist, offers meaningful benefits, including meaningful weight loss and effective diabetes prevention. Regulatory bodies carefully weigh the benefits against the potential risks, and in the case of Tirzepatid, the consensus was in favor of its therapeutic potential.
Q: There have been reports of serious adverse reactions, including one suspected death. How should patients and healthcare providers navigate these concerns?
A: It’s essential for both parties to engage in open dialog. Patients must feel empowered to report any side effects they experience, as seen through the UK’s Yellow Card system. Collaboration between patients and healthcare providers is pivotal in evaluating the ongoing risks and benefits of any treatment.
Q: Dr. Alison Cave from the MHRA stressed the importance of monitoring new medications. What proactive measures can healthcare providers take to ensure patient safety?
A: Healthcare providers should establish regular follow-ups with patients taking Tirzepatid and encourage them to share any adverse effects promptly. it’s also vital to educate patients on what side effects to watch for and when to seek help.Continuous education will play a significant role in mitigating any potential risks associated with the drug.
Q: for those considering Tirzepatid, what practical advice can you offer?
A: Prospective patients should consult thoroughly with their healthcare providers before starting any new medication.An honest discussion about health history, potential side effects, and the weight-related health conditions already present can help foster informed decision-making. It’s also imperative to keep abreast of new data as it’s released,as ongoing research will continue to inform our understanding of Tirzepatid’s long-term safety.
Q: Thank you, Professors Adler and Sattar, for sharing your valuable insights. This case indeed serves as a critical reminder of the importance of patient safety and informed medical choices.
A: Thank you for having us, and remember to always prioritize health through informed discussions and collaborations with healthcare professionals.