By: Daniel O’Keeffe, Qinecsa
The weight-loss benefits of GLP-1 agonists have gone viral around the world, sending demand for the drugs soaring. But what of the poor pharmacovigilance teams now buried under an avalanche of adverse event caseloads, asks Qinecsa’s Daniel O’Keeffe.
The success of Glucagon-Like Peptide-1 (GLP-1) receptor agonists as modern weight-loss solutions is already substantial and has yet to peak.1 But it has generated large volumes of new safety work for drug developers, marketing authorization holders, and industry regulators, as the products are taken up in ever higher numbers around the world.2
For drug companies, pharmacovigilance (PV) systems are struggling to cope with the sheer volume and complexity of adverse event reports generated by these mega-blockbusters. Where these products take the form of injectables (combination products), there is the further complication of potential device failures. These can trigger complaints that are peripheral to the medication itself, adding to the PV workload and potentially clouding drug-related safety insights.
All of this presents a practical operational challenge for the pharma industry, particularly as post-marketing surveillance around GLP-1 products is currently such an active area of research. Real-world signals currently being closely monitored include those around pancreatitis3 and ocular safety.4
The growing off-label use of GLP-1 therapies, driven largely by their demonstrated benefits in weight management,5 is adding to the challenge. In such cases, patients often deviate from approved dosing regimens, raising concerns about both safety and efficacy – as these conditions have not been thoroughly evaluated in clinical trials. This practice may also lead to an increased volume of adverse event reports that fall outside the context of the drug’s approved clinical use.
Saturation Point
The GLP-1 phenomenon highlights how quickly pharmaceutical infrastructure can become inundated.6 Traditional system-supported PV workflows, which involve teams being scaled up to cope with extra demand, were built around relatively predictable patterns of adverse event reporting, primarily via healthcare professionals. They also assume clear distinctions between drug-related adverse events and device-related product complaints.
GLP-1 products have challenged these parameters. The products have been taken up quickly and widely, and real-world side effects are only now emerging. These are being reported directly by patients, recorded by frontline care providers and pharmacists, fed back by drug sales teams, and captured as part of patient support programs (PSPs).
Information is being captured in a wide range of ways too, across multiple channels and sources (some of which may be duplicated), and “in the moment” opportunities to ask key follow-up questions can be missed. This can lead to delays in establishing critical insights, a risk for regulatory compliance (critical signals must be reported swiftly) and ultimately for patient safety.
Pinpointing the Real Source of Complaints
Then there are the device considerations. Injectable GLP-1s are combination products, administered by patients themselves without medical supervision. During reporting potential issues, for instance via a physician, pharmacist or PSP contact, clarity around the source of the problem may be lost. Was it a faulty injector, or the drug itself? The patient may simply want to register a complaint, but the pharma company has a duty to capture, correctly classify, and swiftly report the specifics.
The limitations of manual PV processes become particularly acute at scale. Take the follow-up challenge (capturing a fuller history from the patient). This is magnified in the context of GLP-1s. When patients first volunteer feedback about an adverse event, this is the drug company’s “golden moment” to capture all of the detail that they and regulators will need to properly assess and record a safety signal. In the context of GLP-1s for weight loss, and their mass-scale take-up around the world, reliance on after the fact gap-filling is both impractical and risky from a safety perspective. All of this needs to be addressed head on, rather than worked around.
The Tip of an Emerging Iceberg
What’s happening now with GLP-1s is an important glimpse of what lies ahead. The trend towards combination products is accelerating across multiple therapeutic areas as companies seek to improve outcomes, enhance intellectual property and differentiate offerings. The shift towards patient self-administration is irreversible, too. The convenience it offers patients is too valuable, and healthcare systems under pressure increasingly support moving routine medication administration into patients’ homes and daily routines.
This is a challenge requiring a fundamental rethink of how safety data is captured at source: the vehicle; the method; the format and structure; and the level of detail. Data and the processes used to capture it must be more consistent, and more seamless. The more ambitious the therapies being rolled out to patients, the more critical it is that genuine signals can be identified, qualified and circulated swiftly.
‘Smart intake’ approaches involve using optimized, intuitive systems that have been designed to capture safety data directly from reporters in structured formats, eliminating subsequent manual data entry while also ensuring appropriate routing between adverse event and product complaint pathways (e.g. to support safety reporting for combination products). Because of these efficiencies, scalability is built in.
As patient therapies continue to advance, pharma companies can no longer expect to address soaring case volumes and rising complexity by simply increasing their PV headcount. The only sustainable option is to harness optimized safety intake process automation - to accelerate and improve routine safety data entry, while ensuring high-quality structured capture at the point that patients or professionals are ready to report.
Crucially, this will also liberate PV professionals to focus on the critical activities of scientific assessment and signal detection. Companies that continue to rely on increased team sizes to handle peaks in case volumes risk being perpetually overwhelmed. They could also miss critical safety signals and fall foul of regulatory timelines. In many way, the choices that companies make now will determine the industry’s ability to keep bringing innovative therapies to patients supported by a robust and fit-for-purpose safety surveillance capability.
References
- More than a third of patients on Wegovy pill are new to GLP-1 drugs, study finds, Reuters, 11 February 2026 (study by health data firm Truveta, among early users of Novo Nordisk’s Wegovy weight-loss pill): https://www.reuters.com/business/healthcare-pharmaceuticals/more-than-third-patients-wegovy-pill-are-new-glp-1-drugs-study-finds-2026-02-11/
- IQVIA Market Analysis, 5 January 2026: https://www.iqvia.com/locations/emea/blogs/2026/01/outlook-for-obesity-in-2026
- GLP-1 receptor agonists and dual GLP-1/GIP receptor agonists: strengthened warnings on acute pancreatitis, including necrotising and fatal cases, UK MHRA, 29 January 2026: https://www.gov.uk/drug-safety-update/glp-1-receptor-agonists-and-dual-glp-1-slash-gip-receptor-agonists-strengthened-warnings-on-acute-pancreatitis-including-necrotising-and-fatal-cases?
- PRAC concludes eye condition NAION is a very rare side effect of semaglutide medicines Ozempic, Rybelsus and Wegovy, European Medicines Agency, 6 June 2025: https://www.ema.europa.eu/en/news/prac-concludes-eye-condition-naion-very-rare-side-effect-semaglutide-medicines-ozempic-rybelsus-wegovy
- Microdosing: how ‘off-label’ use of weight loss jabs is spreading from US to UK, The Guardian, July 2025: https://www.theguardian.com/business/2025/jul/12/microdosing-weight-loss-jabs-off-label-glp-1-mountjaro (see also https://pmc.ncbi.nlm.nih.gov/articles/PMC12151216/#sec0005)
- Side effects of GLP-1 receptor agonists, British Medical Journal, August 2025: https://www.bmj.com/content/390/bmj.r1606; Exploring potential associations between GLP-1RAs and depressive disorders: a pharmacovigilance study based on FAERS and VigiBase data, The Lancet, August 2025: https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00317-7/fulltext
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