REGULATORS EXAMINED OZEMPIC AFTER SUICIDAL THOUGHTS
Ozempic And Wegovy Are Brand Names For The Same Drug
People Take Them For Type 2 Diabetes And Weight Loss
Some Of Those Users Reported Suicidal Thoughts
European Regulators Opened A Formal Review Of Those Reports
They Took Nine Months To Answer It
In April 2024 They Found No Causal Link To Self Harm
Researchers Are Now Testing The Same Drugs On Binge Eating
THIS NEWSLETTER IS FOR INFORMATIONAL PURPOSES ONLY. NOTHING IN THIS CONTENT CONSTITUTES MEDICAL, PSYCHOLOGICAL, OR PROFESSIONAL ADVICE. ALWAYS CONSULT A QUALIFIED HEALTHCARE PROFESSIONAL BEFORE MAKING ANY HEALTH RELATED DECISIONS.
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WHAT THE REGULATOR REVIEWED 🔍
The European Medicines Agency Runs A Safety Committee
Pharmacovigilance Risk Assessment Committee Is Its Full Name
Its Job Is To Examine Reported Harms After Approval
Regulators Started The Review In July 2023
They Acted After Patients Reported Suicidal Thoughts
Some Of Those Patients Were Taking Liraglutide
Others Were Taking Semaglutide
Semaglutide Is Sold As Ozempic
Regulators Examined Five Compounds In Total
Liraglutide And Semaglutide Were Two Of Them
Dulaglutide And Exenatide Were Two More
Lixisenatide Was The Fifth
All Five Are GLP One Receptor Agonists
Those Five Are Sold As Eleven Branded Products
Ozempic And Rybelsus And Wegovy Were On That List
So Were Victoza And Saxenda And Xultophy
Byetta And Bydureon And Lyxumia Were On It Too
Suliqua And Trulicity Were The Last Two
In November 2023 The Committee Asked For More Data
Marketing Authorisation Holders Had To Supply It
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WHAT THE COMMITTEE CONCLUDED 📑
Regulators Published Their Conclusion In April 2024
Available Evidence Does Not Support A Causal Association
That Is The Committee Wording Rather Than A Summary
The Committee Tested Suicidal And Self Injurious Thoughts
It Reached That Finding For All Five Compounds
Non Clinical Studies And Clinical Trials Were Part Of It
So Was Post Marketing Surveillance Data
A Case Report Is Not Evidence Of Cause
It Is A Signal That Something Needs Examining
The Committee Spent Nine Months Testing That Signal
Additional Data Was Requested Partway Through
The Finding Is About Causation And Not About Frequency
No Causal Association Does Not Mean Nobody Reported Anything
People Did Report Symptoms
The Committee Assessed Whether The Drugs Produced Them
It Concluded The Evidence Does Not Support That
Regulators Also Said No Update Was Needed
They Keep Monitoring After A Conclusion Like This
A Finding Can Be Revisited On New Data
That Is How Regulators Are Meant To Work
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WHERE THE DRUGS ARE BEING TRIALLED 💊
Eating Disorder Researchers Use The Same Drug Class
Binge Eating Disorder Is The Target There
More Adults Have It Than Anorexia Nervosa Or Bulimia Nervosa
Researchers Have Measured Binge Eating Scale Scores
Semaglutide Produced A Greater Reduction Than A Comparison Group
Anti Obesity Medication Alone Was That Comparison
Semaglutide On Its Own Appeared Effective In That Work
Patients Who Added The Other Medication Did No Better
Liraglutide Produced Significant Reductions In The Same Scores
Some Patients Moved Out Of The Binge Category
The Results Were Not The Same On Every Measure
Patients On Liraglutide Binged Less Often
Placebo Patients Improved Just As Much
The Researchers State The Limits Themselves
Most Studies Are Pilot Trials With Small Sample Sizes
They Call Their Statistical Power Limited
Only One Study Has Directly Examined Semaglutide On Binge Eating
Current Evidence Is Preliminary In Their Own Words
Preliminary Is Not The Same As Proven
The Question Is Still Open
