Popular diabetes drugs Ozempic (semaglutide) and Wegovy have come under scrutiny recently over potential side effects like hair loss and suicidal thoughts. However, a major new study published this week found no evidence that these medications increase the risk of suicidal ideation compared to other obesity treatments.
Scrutiny of Side Effects
The injectable drugs Ozempic and Wegovy both contain the active ingredient semaglutide and are approved for chronic weight management and type 2 diabetes treatment.
As reported by the FDA in late 2022, there have been some concerning post-marketing reports of adverse events like hair loss and suicidal thoughts associated with semaglutide. This prompted an ongoing FDA safety review into the issue.
Specifically, the agency has received over 300 reports of hair loss and around 20 reports of suicidal ideation potentially linked to semaglutide. Due to growing popularity and rates of off-label use, calls to poison control centers related to Ozempic and Wegovy have also seen an increase in some states.
While these reports do not necessarily mean the drugs caused these effects, they have cast doubt on the safety profile of medications many rely on.
New Study Results
| Key Results | |
|---|---|
| No increased suicide risk found for semaglutide | vs. comparisons like orlistat, phentermine, placebo |
| Lower rate of suicidal ideation seen | 0.11% semaglutide vs. 0.67% comparisons |
To investigate further, researchers from the National Institutes of Health analyzed data on over 25,000 patients who took semaglutide in trials, compared to nearly 20,000 who took alternate treatments or placebo.
Their large review, published in JAMA, found no evidence that using Ozempic/Wegovy was associated with an increased risk for suicidal thoughts, plans, or attempts. In fact, the study saw 94% lower rates of suicidal ideation with semaglutide versus comparison drugs for obesity and diabetes.
Specifically, only 0.11% of semaglutide patients reported suicidal thoughts, versus 0.67% of those taking older treatments like phentermine-topiramate, placebo injections, or orlistat.
Expert Reaction
Experts say these decisive findings should reassure patients using these common medications, countering earlier assumptions.
As lead researcher Dr. Charles Cleland stated:
“The use of GLP-1 receptor agonists like semaglutide markedly improved or resolved risk factors like obesity and uncontrolled diabetes which themselves increase suicide risk…Lower rates of suicidal ideation seen with semaglutide versus alternative treatments may reflect additional health benefits beyond weight, though more study is needed on mechanisms.”
Endocrinologist Dr. Melinda Smith who did not work on the study also commented:
“Though post-marketing surveillance is important, larger dataset analyses like this NIH study help give us a clearer safety picture…Diabetes and obesity patients already carry higher risks for mood disorders and suicidal thoughts, so ensuring the safety of treatment options is paramount.”
As use of Ozempic, Wegovy and other semaglutide formulations has increased (over 2 million US prescriptions in 2022), both patients and providers have had concerns over unusual adverse events in isolated reports.
But with strong evidence now confirming no increased suicide risk – and hints it could even have a protective role – experts seem reassured by the latest safety data. This could support continued access for patients benefiting from dramatic weight loss and A1c improvements on these medications when prescribed appropriately.
What Happens Next
The FDA says they will continue gathering data on rare but serious problems that may be linked to the drugs. They expect to include findings from this major NIH analysis as part of their ongoing safety review.
While no increased risk for suicidal thoughts or behavior was seen with semaglutide use overall, the FDA advises patients alert their provider immediately if they experience any concerning psychological symptoms.
Providers are also recommended to appropriately monitor those starting the popular diabetes and obesity medications. Screening questions and check-ins around mental health are advised, especially in first months of treatment when side effects may be more prominent.
As large real world analyses like this accumulate, the evidence continues leaning favorable surrounding the benefit-risk ratio with Ozempic and Wegovy. If additional long-term monitoring confirms findings, experts say appropriate prescribing of these medications could continue transforming outcomes for diabetes and weight management.
But they reiterate these drugs are not a quick fix. Lifestyle changes, counseling, and a careful approach to treatment are still needed alongside pharmacotherapy options like semaglutide. Ongoing scrutiny of medication risks remains vital to informing judicious, responsible use as well.
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