Investigating the Increased Adoption of Weight Loss Drugs: Ensuring Safe and Effective Use

The most recent CDC statistics indicate that 4 out of every 10 Americans are considered obese. Globally, the obesity rate has nearly doubled since 1980.^1,2 Additionally, statistics indicate that during the COVID-19 pandemic, the obesity rate in the US continued to climb, growing by 3% between March 2020 and March 2021, and rates of overweight and obesity continue to soar even within the pediatric population.² According to a survey conducted by the American Psychological Association in February 2021, among those surveyed, 42% adults reported gaining weight with an average reported weight gain of 29 pounds and results also revealed that 10% reported an increase of more than 50 pounds.³

Annually, numerous individuals use various diet plans to lose weight, and many still struggle to adhere to the selected diet plan or fail to lose any considerable weight. As a result, many people often become frustrated and look for alternative ways to lose weight. Some individuals seek counsel from dietitians and nutritionists to assess their eating habits and devise an individualized nutritional plan to lose weight and maintain it, and some individuals may discuss the use of various nonprescription and prescription weight loss drugs with their primary health care providers.

In June 2021, the FDA approved the glucagon-like peptide-1 (GLP- 1 agonist), semaglutide (Wegovy) subcutaneous injection (2.4 mg once weekly) for chronic weight management in adults with obesity or overweight with at least one weight-related condition (such as HTN, T2DM, or hyperlipidemia), for use in addition to a reduced calorie diet and increased physical activity.⁴ This approval marked the first approval for chronic weight management in adults with general obesity or overweight since 2014.⁴ Semaglutide 1 mg injection (Ozempic) was first approved as a treatment for T2DM in 2017 and approved as a once-daily tablet (Rybelsus) in 2019.⁴ In December 2022, the FDA expanded the approval of Wegovy based on data from the STEP TEENS phase 3 clinical trial for the treatment of obesity in adolescents 12 years to 17 years with an initial BMI in the 95th percentile for age and gender.⁵

News stories and ongoing celebrity endorsements on social media about weight loss benefits have led to the popularity and high demand for Wegovy, and the mounting interest in weight loss benefits has led to a nationwide shortage of this drug. The most recent updates about Wegovy can be found on the manufacturer's website. Shortages of Ozempic have also been reported. More information can be found on the NAPB website.

Recent News, Clinical Data, and Approvals for Weight Loss

According to a report released in 2023 by Trilliant Health, prescribers in the US wrote more than 9 million prescriptions for Ozempic, Wegovy, and comparable obesity drugs during the last 3 months of 2022, and the volume of prescriptions for these drugs expanded by 300% between early 2020 and the end of 2022.⁶

In a publication in JAMA Network, researchers discovered that while rare in incidence, the use of GLP-1 agonists for weight loss compared with the use of bupropion-naltrexone was correlated with a heightened risk of pancreatitis, gastroparesis, and bowel obstruction but not biliary disease.⁷ Based on their findings, the authors concluded, “Given the wide use of these drugs, these adverse events, although rare, must be considered by patients who are contemplating using the drugs for weight loss because the risk-benefit calculus for this group might differ from that of those who use them for diabetes. Limitations include that although all GLP-1 agonist users had a record for obesity without diabetes, whether GLP-1 agonists were all used for weight loss is uncertain.”⁶

In June 2023, the American Society of Anesthesiologists released a statement indicating that due to the increasing use of the GLP-1 receptor agonists, the ASA suggests withholding the GLP-1 receptor agonists before elective surgery to diminish the risk of complications related to anesthesia in adults and children.⁸ ASA President Michael W. Champeau, MD, FAAP, FASA stated, “While there is currently a lack of scientific data on how GLP-1 receptor agonists affect patients having surgery and interact with anesthesia, we’ve received anecdotal reports that the delay in stomach emptying could be associated with an increased risk of regurgitation and aspiration of food into the airways and lungs during general anesthesia and deep sedation. These complications can be serious, so we are providing guidance on when GLP-1 agonists should be stopped in advance of an elective procedure.”⁸

In a news story on the American Pharmacists Association website, findings from a survey revealed that nearly 50% of Americans surveyed indicated that they would be willing to spend $100 a month for weight loss drugs. Additionally, two-thirds noted that they had an interest in using one of the weight loss drugs to improve their physical health, while 51% stated that self-image was their primary reason.⁹

In September 2023, the FDA updated the labeling for Ozempic to include a warning about the potential risk for ileus or an intestinal blockage and an augmented risk for hypoglycemia if combined with insulin or insulin secretagogue. The FDA also states, “Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.”^10,11

In November 2023, the FDA approved tirzepatide (Zepbound) injection for chronic weight management in adults with obesity or greater or overweight or greater with at least one weight-related condition (such as HTN, T2DM, and hyperlipidemia) for use, in addition to a reduced calorie diet and increased physical activity. Tirzepatide, the active ingredient in Zepbound, is already approved under the trade name Mounjaro to be used with diet and exercise to help improve glucose in adults with T2DM.¹²

Perspectives from Pharmacists and Prescribers

Retail pharmacist stated, “I often encounter several patients asking about weight loss medications, and I encourage patients to discuss the issue with their primary health care providers to determine if this is the best approach based on weight loss goals, medical and medication history. Unfortunately, some patients see weight loss drugs as a quick fix to their weight problems but do not realize that, just like any other drug, there are potential adverse effects, contraindications, and drug/drug interactions that should be considered first. When used as directed, weight loss drugs are safe and effective.”

An endocrinologist stated, “I have prescribed weight loss drugs to patients who have struggled with obesity or overweight issues most of their lives. Before prescribing, I discuss the pros and cons, review the patient’s risk factors for other health issues, and let patients know that diet and exercise are still the best options for maintaining weight loss. I had a patient come to my office to discuss unexplained weight gain, and she wanted to try weight loss drugs. After examination, assessing her symptoms, and receiving lab results, she was diagnosed with hypothyroidism and PCOS, which explained her weight gain. After treating the conditions, diet, and exercise, she started losing weight and did not need weight loss medications.”

Retail pharmacist stated, “Weight loss drugs are appropriate for patients meeting the approved indications and can be effective. I had a patient ask me about weight loss medications, and she told me that she read about some of the adverse effects, changed her mind, and ultimately decided to stick with diet and exercise because she only wanted to lose a few pounds. A lot of people often see celebrities talk about weight loss drugs, and then people think it is a magic remedy and don’t consider that these drugs have approved indications and have adverse effects, risks, and warnings that are often not considered. I recommend that patients discuss the use of these drugs with their doctors, who know their medical history and can make informed decisions based on their recommendations.”

An internist stated, “Whenever I have encountered a patient inquiring about using weight loss medications, I always encourage patients to try diet changes and exercise first to see what happens because nothing is a substitute for a healthy balanced diet. In prescribing weight loss drugs to appropriate candidates, I have had patients who have experienced ADRs and some patients who have not, so prescribing these medications requires consideration of several individual patient factors to determine the best route for weight loss in each patient.”

Conclusion

The drug shortages of Wegovy illustrate the high demand for this agent, and just like any other medication, patient responses and adverse effects vary from individual to individual. The decision to use weight loss drugs should begin with a conversation between prescribers and patients to ascertain the best plan for successful and long-term weight loss based on the patient’s risk factors, medical and medication history, and goals for weight loss. The availability of weight loss drugs provides prescribers and patients with drugs to assist them in their weight loss journey; however, it is essential that patients understand the proper use of these agents and that there is no “magic” or quick fix to weight loss, which requires a commitment to adhering to a healthy diet and routine exercise. Patients who elect to use weight loss drugs should be counseled on the potential adverse effects of selected agents, treatment expectations, as well as warnings and monitoring parameters. There is no “one size fits all” plan for successful weight loss and maintaining weight loss. The first critical step for patients who struggle with weight issues is to seek guidance from their primary health care providers to assess their dietary habits, exercise patterns and review risk factors including, medical conditions and medications that may contribute to weight gain or make it more challenging to lose weight and to devise a patient-centered plan that may also include the use of an appropriate weight loss drug to achieve weight loss goals, reduce risk factors and improve overall health.

References

1. Adult obesity facts. CDC. May 17, 2022. Accessed February 23, 2024. https://www.cdc.gov/obesity/data/adult.html
2. Laurence E. Obesity statistics and facts in 2024. Forbes. Updated January 10, 2024. Accessed February 23, 2024. https://www.forbes.com/health/weight-loss/obesity-statistics/
3. Weir K. The extra weight of COVID-19. American Psychological Association. July 1, 2021. Accessed February 24, 2024. https://www.apa.org/monitor/2021/07/extra-weight-covid
4. FDA approves new drug treatment for chronic weight management, first since 2014. News release. FDA. June 4, 2021. Accessed February 23, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-chronic-weight-management-first-2014
5. FDA approves once-weekly Wegovy injection for the treatment of obesity in teens aged 12 years and older. Published Dec. 23, 2022. Accessed February 23, 2024.www.novonordisk-us.com/content/nncorp/us/en_us/media/news-archive/news-details.html?id=151389
6. 2023 trends shaping the health economy. Trilliant Health. https://www.trillianthealth.com/hubfs/TH_Annual%20Report_2023.10.25%20(2).pdf
7. Sodhi M, Rezaeianzadeh R, Kezouh A, Etminan M. Risk of gastrointestinal adverse events associated with glucagon-like peptide-1 receptor agonists for weight loss. JAMA. 2023;330(18):1795–1797. doi:10.1001/jama.2023.19574
8. Patients taking popular medications for diabetes and weight loss should stop before elective surgery, ASA suggests. American Society of Anesthesiologists. June 28, 2023. Accessed February 23, 2024. https://www.asahq.org/about-asa/newsroom/news-releases/2023/06/patients-taking-popular-medications-for-diabetes-and-weight-loss-should-stop-before-elective-surgery
9. Sartain M. Almost one-half of Americans would spend $100 a month for weight loss drugs. American Pharmacists Association. July 5, 2023. Accessed February 23, 2024. https://www.pharmacist.com/Pharmacy-News/almost-one-half-of-americans-would-spend-100-a-month-for-weight-loss-drugs
10. Ozempic drug safety-related labeling changes (SrLC). FDA. Accessed February 23, 2024. https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2183
11. Wegovy PI.
12. FDA approves new medication for chronic weight management. PR Newswire. November 8, 2023. Accessed February 23, 2024. https://www.prnewswire.com/news-releases/fda-approves-new-medication-for-chronic-weight-management-301982063.html