GLP-1 medications have transformed the treatment of Type 2 diabetes and obesity. Their ability to regulate blood sugar and support significant weight loss has driven widespread adoption across healthcare. Following initial FDA approval in 2005 as a drug to treat Type 2 diabetes through the regulation of blood sugar and stimulation of insulin secretion, it was discovered that GLP-1 drugs, at higher dosages, were an effective, though not risk free, modality for treating obesity, resulting in FDA approval for such treatment in 2014.
The benefits of GLP-1 therapy continue to grow beyond the treatment of Type 2 diabetes and obesity, including the treatment of Type 1 diabetes, fatty liver disease, cardiovascular disease, sleep apnea, Parkinson’s, Alzheimer’s, osteoarthritis, and addiction, to name a few. Unfortunately, along with the expanding list of benefits, we have also seen a growing number of complications and side effects, some that are transient and others that are causing patients to not only abandon use, but also allegedly caused significant harm.
Expanding Side Effect Profile
While gastrointestinal issues (nausea, vomiting, diarrhea, and constipation) seem to remain the most prevalent adverse effects from taking GLP-1s, reports have also highlighted concerns involving pancreatitis, kidney complications, gallbladder disease, gastroparesis, vision issues, appreciable loss of muscle mass, bone density deterioration, and tendon injuries. With lifetime therapy, which appears to be required in order to sustain weight loss benefits and diabetic control, there is growing concern over potential additional downstream effects from chronic use.
One example of this is the reported acceleration in muscle mass deterioration and diminishment of bone density. Approximately 30% of the weight lost on GLP-1s is muscle mass. Unless the patient is engaging in resistance/strength training, with the proper balance of macronutrients, they are doing nothing to counter the effect of this loss. This is compounded by the fact that adults over 50 years old lose approximately 1-3% of their muscle mass each year, unless a proper regimen of diet and exercise is employed. Studies have shown that patients taking GLP-1s are less likely to engage in regular exercise and those that were exercising prior to taking GLP-1s may see the level of activity decrease after introduction of the medication due to fatigue and other side effects. As a result, bone density is also compromised which provides an increased risk of falls, and resultant injuries.
The leading cause of death by accident over the age of 65 is falls with injury. Elderly members of the population that fall and sustain fractures of the hip have a significantly diminished life expectancy following the fall. Consequently, while the benefits of GLP-1 drugs continue to be identified, their use, particularly in the aging population, may well increase the risk of morbidity and mortality in this aging population.
Where Liability Risks May Emerge
Drug manufacturers, compounding pharmacies, telehealth providers, and prescribing clinicians all face potential legal exposure from these medications. Areas of concern include manufacturing defects, design defects, failure-to-warn allegations, inadequate monitoring, and risks associated with compounded formulations.
With respect to pharmaceutical companies, they will always be subject to manufacturing defect claims but that would apply to any drug, not just GLP-1s. They are subject to risks associated with design defect— – allegations that they could have eliminated some of the risk through an alternate design of the drug. Claims may include failure to warn users of current risks, and risks identified in the future, enhance the liability exposure portfolio and increase the likelihood that manufacturers knew or should have known of a risk that they didn’t warn the public about or failed to report side effects, will provide grounds for future litigation. While, thus far, pharmaceutical companies have engaged in the necessary clinical trials to allow for FDA approval of GLP-1s, as side effects continue to rise, the risk portfolio will change.
For compounding pharmacies, there are clear issues with appropriate mixes of the drugs, including additives such as vitamins B6 and B12, “copycats,” and products that aren’t effective or cause injury. Current lawsuits have set forth additional claims such as deceptive marketing, with companies allegedly promoting health benefits of GLP-1s for which there is purportedly no merit.
Telehealth providers and medical professionals will also be subject to failure to warn claims, failure to monitor claims, injuries stemming from off label use (addiction/cravings; , Type 1 diabetes, fatty liver disease, Parkinson’s disease, Alzheimer’s disease, osteoarthritis, etc.). Given the dramatic nature of weight loss, reports of malnutrition, pancreatitis, vision issues and the like, both telehealth organizations and primary care providers should be wary of these complications and establish a robust methodology of patient monitoring to ensure that any signs and symptoms of these more serious side effects are recognized and treated as soon as possible.
Managing Risk Through Vigilance
Manufacturers must closely monitor adverse-event data and continuously evaluate emerging safety signals. Providers must carefully screen patients, assess co-morbidities, review drug interactions, and monitor outcomes throughout treatment.
Hypervigilance will play a role for all, including the patient. For the pharmaceutical manufactures manufacturers it’s making certain that they are monitoring adverse events, reactions and negative interactions, and constantly updating any warnings. For compounding pharmacies, it’s important to adhere to warnings. The FDA has sent out warnings about fraudulent products, and have strict policies for compounders, although compounded medications are themselves not regulated (the FDA does not determine their safety or effectiveness).
Telehealth entities need to be very sensitive with respect to properly screening (co-morbidities, drug interactions, etc.) and monitoring patients. They also have to be mindful with respect to false advertising. For practitioners who have established a more traditional physician-patient relationship, monitoring will be key. A provider cannot issue the prescription, see the patient in 3-6 months and declare victory because a patient’s BMI is within, or trending toward, the normal range and blood sugar levels are appropriate.
The approach needs to be more holistic. A litany of questions arises: Is there muscle wasting? Has a baseline bone density determination been made? Is the patient a better candidate for surgical intervention? Has this been discussed? Have base line laboratory studies been repeated?
GLP-1 medications represent one of the most significant therapeutic advancements in modern healthcare, offering meaningful benefits for patients with diabetes, obesity, and an expanding range of chronic conditions. However, as their use broadens and treatment durations lengthen, a more complete picture of their long-term safety profile is beginning to emerge.
While the clinical promise of these therapies is undeniable, the growing body of evidence surrounding adverse effects, patient monitoring challenges, and potential liability exposures highlights the need for caution and vigilance. Pharmaceutical manufacturers, compounding pharmacies, telehealth providers, and prescribing clinicians each play a critical role in ensuring that these medications are used safely and responsibly.
Ultimately, the continued success of GLP-1 therapies will depend not only on their effectiveness but also on the commitment to comprehensive patient management, proactive risk mitigation, and ongoing evaluation of emerging safety concerns.
About the Author
Bill Bower is the healthcare vertical leader at Gallagher Bassett. Bill_Bower@gbtpa.com