1. Introduction
Ozempic is a semaglutide injection that the FDA approved as a treatment for people who have type 2 diabetes or are prediabetic. Ozempic has recently gained popularity online, but not for its use in treating diabetes. Instead, Individuals are boasting about taking Ozempic off-label for weight loss. Off-label refers to prescribing a drug for a reason other than its approved purpose. Although off-label prescribing can sometimes be beneficial, it is controversial as there is a lack of research on the drug being used in different scenarios, as well as the potential problem of taking away medication from those who need it. Regardless of these concerns, influencers on TikTok continue to promote Ozempic as a weight-loss medication, oftentimes leaving out the valid concerns regarding off-label use. Since influencers monetize their content through engagement, one has to wonder whether they have a responsibility to monitor their content to prevent potentially harming their viewers.
The goal of this study is to identify the language that influencers use when discussing Ozempic, draw awareness to this matter, and imply the ethical implications of influencers discussing and promoting off-label drug use as content. We aim to investigate how influencers discuss Ozempic in their content and potentially draw inferences about how these individuals have influenced the use of Ozempic.
2. Literature Review
Ozempic and FDA regulations: Side effects
Ozempic, a semaglutide injection, was approved by the FDA in 2017 to prevent type-2 diabetes. Typically, doctors prescribe Ozempic to pre-diabetic individuals. The medication aids in weight loss and enhances glycaemic control (Chamberlin & Dabbs, 2019). Although new treatments are promising and offer numerous benefits to those in need, it is also vital that proper regulations and warnings are in place to ensure user safety. In the United States, the FDA has extensive requirements for a drug to gain market approval and for effective communication with consumers regarding potential side effects. The FDA has several phases a drug must undergo before approval. Phase I trials are to provide initial safety evaluation, determine safe dosing ranges, and identify common side effects and the toxicity profile of the drug. The Code of Federal Regulations for Safety Reporting outlines what constitutes an adverse effect and the requirements for companies to disclose these effects to the FDA. The Code is exceptionally detailed, emphasizing the importance of sponsors in disclosing adverse effects. In the context of Ozempic, Chamberlain and Dabbs (2019) note the risks of thyroid cancer, pancreatitis, and various complications that may arise from combining semaglutide with certain pre-existing conditions, discovering these adverse effects results from years of research and clinical trials. There are extensive and detailed requirements for drugs to disclose the potential adverse effects associated with their use. Complications arise when individuals use the drug for unintended purposes.
Regulations on drug ads
The FDA’s extensive regulation does not end once the drug is approved. According to Van Norman (2016), the goal of regulating drug advertising is to protect consumers from unsafe or dishonest advertising directed at vulnerable populations while ensuring that new and safe medications reach the public quickly. The FDA requires that advertisements for the medication disclose the potential adverse effects to consumers. The FDA has specific requirements for all advertisements. One of the guidelines includes having a fair balance between the risks and benefits of the drug. In general, the FDA contends that the advertisement cannot be “false or misleading” at all. It is proven that medical advertisements influence consumers’ requests for prescriptions (Frosch et al., 2010).
Direct-to-consumer advertising of prescription medication has long been a subject of debate (Calfee, 2002). While many emphasize the dangers of direct-to-consumer advertising (DCTA) (Gilbody et al., 2005), others contend that DCTA may also provide certain benefits. Many recognize that DCTA could pose a threat to consumers through targeting vulnerable individuals but also believe that if executed properly, DCTA can be an effective way to inform individuals about the treatment options available (Almasi et al., 2006; Calfee, 2002; Gellad & Lyles, 2007). Therefore, the FDA must regulate the medications advertised to consumers, as this can directly influence an individual’s prescription preferences.
Off-label use
Although there are extensive measures in place to ensure that every drug is safely produced, used, labeled and advertised, some avoid these regulations through off-label drug use.
Through the FDA, every drug has a “labeled” use that is supported by an abundance of trials and research demonstrating the drug’s efficacy for its intended purpose. When a drug is prescribed to an individual for an intention other than that of the labeled use, that is considered “off-label” prescribing. A recent study showed that off-label prescriptions accounted for 21% of prescriptions in a standard office setting (Syed et al., 2021). It is safe to say that off-label prescribing is not uncommon and can offer certain benefits to patients. Supporters of off-label prescribing argue that many patients benefit when they receive drugs or devices under circumstances not specified on the label approved by the FDA. An off-label use may provide the best available intervention for a patient, as well as the standard of care for a particular health problem (Dresser & Frader, 2009). They contend that, if appropriately researched, off-label use can be beneficial to patients and provide treatments that would not have been available otherwise.
Although off-label prescribing can pose significant benefits, it has been very controversial in recent years and has been the subject of debate (Ghinea et al., 2012). Many have concerns about off-label prescribing, as “only about 30% of off-label prescribing was supported by adequate scientific data” (Gupta & Nayak, 2014, p. 1). Individuals are wary of off-label prescribing because there is not the same level of research and trials involved with off-label use. Some contend that the “lack of FDA approval means that off-label uses are not given the same degree of scientific scrutiny as labeled indications” (Radley et al., 2006, p. 2). Legally, off-label prescribing is not regulated by the FDA; instead, the responsibility is entrusted to medical providers to make an informed decision about what is best for the patient (Dresser & Frader, 2009). However, the FDA regulates the marketing and advertising of off-label uses of medications. Before 1977, the promotion of the off-label use of a medication was entirely illegal. However, as a result of this, many drug companies were marketing their drug covertly, resulting in a lot of controversy and dangerous advertising without adequate research. The FDA attempted to remedy this by requiring some form of research before approving advertising off-label use.
The FDA understood that it was unreasonable to expect pharmaceutical companies not to attempt to increase the use of their drug, especially in terms of off-label use. To remedy this, the FDA implemented new guidelines that allowed drug companies to submit scientific data on new uses of the drug in the hope of speeding up the off-label approval process. The purpose of these guidelines is to find a balance between unrealistically restricting the off-label use of medication and ensuring consumer safety. It is generally understood that off-label use can be dangerous due to a lack of research on the impacts that the drug can have on individuals for whom it is not intended (Ghinea et al., 2012; Gupta & Nayak, 2014; Radley et al., 2006). Although the FDA can require some research prior to advertising of off-label use, this does not entirely ensure the safety of its usage. As a drug intended for those who are pre-diabetic or have type -2 diabetes, Ozempic has become increasingly popular through off-label use (Wojtara et al., 2023), which raises concerns about its impact on those whom the drug is not intended for.
Off-Label use of Ozempic
Ozempic, in particular, is a medication that has seen an increase in off-label use in recent years. Although Ozempic is intended to be a medication for type-2 diabetes, it has been frequently prescribed as a weight-loss medication (Wojtara et al., 2023). The off-label use of Ozempic is associated with a range of complications affecting not only the user but also external parties. The most recent data indicate that prescriptions for Ozempic have increased by 152% compared to the same period in the previous year (Wojtara et al., 2023). The FDA has disapproved Ozempic as a weight loss medication; however, certain studies have found it to be an effective treatment for weight loss. One study reported that after one year of taking 0.4 mg Ozempic, participants without diabetes lost an average of 13.8 percent of their body weight compared to the control group, which lost an average of 2.3 percent (O’Neil et al., 2018). Note that the participants in this study were also instructed to exercise daily and reduce their daily calorie intake by 500 calories. Although studies to date have yielded positive results, Ozempic has not yet been approved by the FDA as a weight loss medication.
Although Ozempic can be an effective weight loss treatment, that is not to say that there are no considerable side effects. The side effects can include hypoglycemia, gastrointestinal effects, cardiovascular risks, and drug interactions’ (Wojtara et al., 2023). Very recently, a lawsuit has been filed against Novo Nordisk, the manufacturer of Ozempic, for allegedly failing to disclose that the medication causes gastroparesis (Johnson, 2023). The research states that the risk calculus will differ depending on whether a patient is using these drugs for diabetes, obesity or just general weight loss. People who are otherwise healthy may be less willing to accept the potential for these serious adverse events. Semaglutide, the active ingredient in Ozempic, is also known to cause thyroid tumors in rodents (“Weight Loss Breakthrough?,” 2021). The adverse effects of the drug only raise more questions in regards to the safety of the consumer. In addition to affecting the consumer, the off-label use of Ozempic is also impacting those who need the drug. There have been severe shortages of Ozempic for individuals who are pre-diabetic or have type-2 diabetes since Ozempic’s surge in popularity. Many do not realize that when off-label prescription occurs, it is taking the medication away from those for whom it is intended.
Influencers
In the wake of social media, marketing has undergone unprecedented changes. In this new era, a new, efficient, and cost-effective aspect of marketing has emerged: influencers. Influencers are a novel way to market and reach a large number of consumers simultaneously. Influencers are defined as everyday Internet users who transform themselves into a new form of social media microcelebrity (Edström et al., 2016). The era of influencers has taken social media by storm, as individuals acquire millions of followers through instant interaction with their audience. This interaction can be highly influential on the viewer, as consumers increasingly use social media to gather information on which to base their decisions, and they often view these influencers as role models (Barta et al., 2023). There is no doubt that influencers have a significant impact on their viewers, which can be concerning in the absence of proper regulations.
Since influencers are a relatively new phenomenon, there are no established rules regarding the content they create. The landscape in which influencers produce content can be characterized by its absence of enforced legal boundaries and industry norms regarding advertising formats and ethical standards (Edström et al., 2016). Although there appears to be an absence of legal boundaries for influencers, TikTok has community guidelines that outline the types of videos that are not acceptable. In the mental and behavioral health section of TikTok’s community guidelines, it indicates that they do not allow showing or promoting disordered eating or any dangerous weight loss behaviors (TikTok, 2023). It raises the question, then, if TikTok clearly states that it does not allow dangerous weight loss behaviors, why do videos regarding Ozempic use for weight loss still exist on the app? The lack of regulation, coupled with their undeniable influence on viewership, is a cause for concern. Not only is the regulation of content unique, but the revenue from influencing is unlike that of traditional advertising.
Influencer monetization
In the unregulated landscape of social media, consumers compensate influencers indirectly, primarily through their attention. However, the attention industry is highly lucrative. The influencer economy is booming, having grown from $1.7 billion in 2016 to a projected $16 billion by 2022 (Mardon et al., 2023). Researchers have coined this phenomenon the “attention economy.” To gain this attention, influencers must differentiate themselves from others, either through a consistent personal brand, shock value, or staying up-to-date with trends. The ultimate goal of influencers is to play the “visibility game” by analyzing and adhering to trends and algorithms to gain viewership and engagement (Gomes et al., 2022). They explain how promotion and marketing through influencers is a grey area, which is oftentimes intentional. This makes viewers particularly vulnerable, as individuals are sometimes unable to distinguish between content and promotion. Gomez (2019) further explains that once an influencer gains attention, they must then establish themselves as a trusted source of information to their viewers, and their viewers must be willing to be influenced by this source. Once the influencer is in this position, they can generate revenue through various means, including TikTok itself, brand partnerships, merchandise sales, and a range of other non-traditional sources. Ultimately, influencers make their money by appealing to a broad audience as a source of information.
Influencers and Ozempic
Given the considerable influence exerted by social media influencers on their audiences, it is alarming to contemplate the potential for these individuals to endorse the off-label utilization of pharmaceuticals with minimal oversight or regulatory frameworks in place. The popularity of Ozempic is often attributed to its widespread social media presence and influence from celebrities (Han et al., 2023). It is oftentimes challenging for individuals to conceptualize the effects that social media can have on the world. However, the fact is that social media platform users started promoting semaglutide/Ozempic as a weight-loss treatment, and the associated increase in demand has contributed to an ongoing worldwide shortage of the drug associated with levels of non-prescribed semaglutide intake (Arillotta et al., 2023). This is not the first time that non-medical professionals have promoted drugs. When Kim Kardashian (an American socialite and media personality) promoted a pregnancy sickness drug in 2015, the FDA ordered her to take down the post immediately and provide a complete list of the side effects (Haenlein et al., 2020). Influencers, however, have yet to face restrictions from the FDA, and the TikTok guidelines are not yet heavily enforced, which may hinder the implementation of this kind of regulation. In a study of the frequency of TikTok videos featuring the Ozempic hashtag, Basch et al. (2023) found that the 100 videos they extracted from the platform garnered almost 70 million views. The study also noted that these videos were uploaded almost entirely by non-medical professionals. Therefore, the promotion of off-label Ozempic use on social media, considering the dangers of off-label consumption in light of TikTok’s demographics, raises concerns for consumers, healthcare professionals, and regulatory bodies.
TikTok’s demographics
Recognizing that influencers depend on their audience for revenue, the question then arises: Who is this audience? The danger of the influencer comes into play, particularly regarding children. Given the absence of regulation regarding content on TikTok, it is troubling to consider the vast number of individuals who can be exposed to such material. Unfortunately, it is challenging to determine the number of children using the app firsthand, as they are technically below the age limit set by TikTok (13 years old). However, a recent survey showed that the popularity of TikTok among tweens surpasses that of other social media platforms, such as Snapchat, Instagram, and Facebook, with 44% of 6- to 12-year-olds regularly participating on the short-video sharing platform (Demeulenaere et al., 2020). Minadeo and Pope (2022) concurred that TikTok has a large number of adolescent and young users, and they also suggest that food, nutrition, and weight-related posts are particularly popular on the social media platform. They found that a key theme among these videos is the glorification of weight loss and noted the lack of expert voices providing nutrition information. Their study found that videos under the hashtag for weight loss garnered a total of 9.7 billion views. Given that this subject is undoubtedly popular on TikTok, it is likely a topic that influencers will seek to address, especially if they are promoting a weight loss medication.
The subsequent research questions (RQ) are formulated based on the existing literature review and our research queries.
RQ 1: Do the TikTok videos concerning Ozempic mainly represent its approved medical uses rather than its application for weight loss?
RQ 2: Do TikTok influencers promote the off-label use of Ozempic in their videos as beneficiaries while detailing their experiences with the prescription and weight loss?
RQ 3: Do TikTok influencers portray themselves as experts and share their views on the use of Ozempic?
RQ 4: Do TikTok videos about the use of Ozempic present a positive and transformative perspective on the off-label application of this prescription medication?
RQ 5: Do influencers on TikTok endorse the off-label use of Ozempic for its positive attributes without sufficiently explaining its side effects?
RQ 6: Do TikTok connotations suggest a marked prevalence of positive sentiment?
3. Methodology
3.1. Research design
To maintain the integrity of the sample, we undertook a deductive qualitative analysis of TikTok videos by establishing a new TikTok account specifically for this study. Therefore, we mitigated the potential impact of the algorithm associated with a personal TikTok account on the video content displayed in our search results. To aid our search and documentation of relevant instances within the chosen videos, we compiled a comprehensive list of pertinent terms. This terminology list includes terms we expected to be related to the off-label use of Ozempic. To identify these videos, we used the search function within the TikTok application, entering “Ozempic” and filtering the results to show only video content. We then examined the videos prioritized by TikTok’s algorithm, which organizes content based on popularity, assessed by the number of likes and comments, thereby influencing the order in which videos were viewed. While not all videos originate from recognized influencers, the most popular ones likely share a comparable level of influence. Our sample comprises 160 distinct TikTok videos for further analysis.
In developing the instrument for our study, guided by our research questions regarding the anticipated themes in the videos, we compiled a deductive qualitative list of terms for observation in each video. This list aims to provide insights into how the content is portrayed. Using this list, we documented the instances where these terms appeared throughout each video.
3.2. Data
Upon compiling and analyzing the videos, we quantified the frequency of each term present within the sampled videos and systematically recorded the data in an Excel spreadsheet for further analysis. Our research does not involve human participants or surveys. thus, we believe that the publicly available content from influencers suggests a low likelihood of encountering challenges related to the Institutional Review Board (IRB).
4. Results and Analysis
4.1. Descriptive analysis
In our analysis, we systematically cleaned and organized the data by utilizing a set of defined variables, coding schemes, and relevant metrics to ensure consistency and accuracy. To facilitate our examination, we employed descriptive analytics using IBM SPSS version 29.0.2.0, which enabled us to determine the frequency of specific terms that appeared in the collected TikTok videos. By scrutinizing a diverse array of terms, we can investigate how influencers portray the use of Ozempic to their audience, thereby gaining insights into the narratives and representations that shape viewer perceptions.
Terms presented in the video were assigned a code of 1, while those not presented received a code of 0. This coding method was uniformly applied to all terms on the deductive list, ensuring consistent categorization based on their presence or absence in the video. In addition to analyzing specific terms, each video was classified as having either a positive or negative connotation. A negative connotation was assigned a code of 1, an uncertain connotation received a code of 2, and a positive connotation was assigned a code of 3. For this study, connotation was defined as the portrayal of Ozempic usage. Key elements of connotation include the creator’s perspective, the nature of the video, its context, any descriptive language (whether positive or negative) used within the video, and other linguistic indicators that may favor one interpretation over another. Videos that do not exhibit a distinct connotation, such as those created solely for informational purposes, are classified as “uncertain.”
4.2. Results and findings
After conducting an extensive frequency and descriptive analytics test, we meticulously compiled a comprehensive list of terms that appeared across the 160 videos in our dataset. Each term was analyzed not only for its presence but also for its frequency and relevance within the context of the content. Moreover, we paid careful attention to the connotation associated with each video, assessing how the off-label use of Ozempic was portrayed. This connotation analysis helps in understanding the underlying sentiments and attitudes conveyed in the content, thus providing deeper insights into public perception and media portrayal of Ozempic’s off-label applications.
Figure 1 provides a detailed breakdown of these terms, alongside the percentage of videos in which each term was mentioned. The term “Weight Loss” is the most frequently referenced, appearing at a rate of 78.8%, which highlights its significant emphasis. Next, “Beneficial” is recorded at 67.5%, while “Empowerment” reaches the midpoint with a frequency of 50.0%. Other notable terms include “Transformation” at 42.5% and “Side Effects” at 33.1%. In contrast, terms like “Struggle” (1.3%) and “Lifesaving” (1.9%) are located at the lower end of the frequency spectrum, suggesting they are less commonly cited in the examined context.
These terms, while present, are not central to the overall discourse. Overall, the data suggests a strong emphasis on the positive aspects of weight loss, including its benefits, empowering effects, and transformative potential. While side effects are acknowledged, they do not take precedence. The low frequency of “cost” may suggest that it is not a significant concern or that it is not extensively discussed within this particular dataset. The data indicates that struggles and life-saving events are infrequent topics. Essentially, the finding underscores the prevalence of positive language and themes related to weight loss, with a secondary emphasis on potential side effects. The very low percentages reveal terms that are rarely used in the dataset.
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In Figure 2, the analysis of 160 videos reveals that the positive connotation prevails, comprising 77.5% of the total, which signifies a predominantly favorable sentiment. In contrast, the negative connotation accounts for 15.6%, indicating a smaller but significant portion of unfavorable sentiment. Meanwhile, the uncertain connotation is recorded at 5.6%, demonstrating a slight degree of ambiguity in the findings. This distribution underscores a pronounced tendency towards positivity.
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5. Discussion and Implication
The term weight loss was the most frequently mentioned in the examined videos, appearing in 78.8% of them. This finding reinforces our conclusions that TikTok content concerning Ozempic predominantly emphasizes its use for weight loss rather than its officially sanctioned medical applications. It is particularly noteworthy that, despite the significant prevalence of the term “weight loss,” none of the videos included terminology such as “off-label” or “diabetic.” This lack of relevant terminology further contextualizes the situation, suggesting that the representation of Ozempic’s usage may not accurately reflect its intended medical purpose and could potentially lead to misconceptions among viewers.
The term beneficial emerged as the second most frequently utilized word, appearing in 67.5% of the videos examined in the analysis. This prevalence suggests a notable emphasis on the positive attributes or advantages associated with the content featured in these videos. The high frequency of the term underscores the creators’ intention to highlight the favorable outcomes or benefits that viewers may derive from the information or themes presented. This emphasis on the term “beneficial” reflects a broader trend in content creation that prioritizes the promotion of constructive and advantageous messages to engage and inform the audience effectively.
The term empowerment emerges with a midpoint frequency of 50.0%. This indicates that the theme of empowerment is present in half of the analyzed content, suggesting a significant emphasis on this concept within the overall narrative. The prevalence of empowerment in these videos underscores its importance and relevance to the topics being discussed, reflecting a balanced representation that warrants further exploration and understanding of its implications within the presented context.
The term transformation has emerged as the fourth most frequently cited term among those analyzed, appearing in a notable 42.5% of the videos examined. Many of these videos featured compelling before-and-after illustrations that depicted the physical changes of the creators after they began using Ozempic. In each of these transformation narratives, the subjects consistently exhibited a significantly thinner appearance in the “after” segments compared to their original selves. This specific genre of content can be effectively regarded as a promotional strategy, as the creators explicitly highlight the positive outcomes and benefits associated with using this medication for weight loss purposes. Through these vivid visual representations, they aim to influence viewers by showcasing transformative results that can be achieved, thereby encouraging the use of Ozempic as a viable option for those pursuing weight loss. Furthermore, this trend reflects a broader cultural fascination with physical transformation and the lengths to which individuals are willing to go to achieve their desired body image.
The term side effects appeared in approximately 33.1% of the videos we analyzed. Among these videos, a variety of user experiences were shared. Some individuals detailed the adverse side effects they had encountered, while others confidently asserted that they had experienced no side effects at all. It is crucial to note that merely mentioning side effects in a video does not automatically indicate a warning; it is simply part of the discussion. This finding suggests that roughly 78% of the videos examined did not mention any side effects whatsoever. This distinction is vital for understanding viewer perceptions and the overall narrative surrounding side effects in the assessed medium content.
The results of the connotations also support our conclusions. The distribution of connotations within the 160 analyzed videos indicates a pronounced prevalence of positive sentiment. The finding substantiates that 77.5% of the data points are classified as having a positive connotation. In stark contrast, only 15.6% of the data points are categorized as negative. The “Uncertain” category is the least represented, comprising only 5.6% of the total dataset. These findings strongly suggest that positive connotations dominate the overall sentiment, while negative connotations, although present, constitute a significantly smaller proportion compared to their positive counterparts. Additionally, the limited number of data points classified as uncertain implies a definitive sentiment in the majority of cases. In summary, the analyzed videos exhibit a robust overall positive sentiment, with negative and uncertain connotations occurring much less frequently.
In summary, the study’s results primarily addressed our initial research questions. The thorough analysis of the gathered data revealed that a substantial proportion of the videos examined focused on the theme of weight loss while also conveying a positive narrative. This trend suggests that social media influencers are presenting the off-label application of Ozempic in a favorable light. Additionally, it was observed that nearly 43% of the videos included transformation narratives, which illustrated a comparative analysis of the creators’ physical appearances before and after using Ozempic. Such content can be interpreted as promotional, as it emphasizes the attractive results associated with the off-label use of this medication. However, it is essential to note that this study did not provide sufficient evidence to conclude that influencers positioned themselves as experts on the subject matter, nor did it identify any instances of “celebrity” endorsements related to the analyzed content.
6. Conclusion and Limitation
The research conducted on the nature of TikTok videos about Ozempic provides insight into the discussion of off-label medication use on social media. Although this study is preliminary in its field, it gives some indication of a potentially dangerous and under-researched element of free speech on social media. As discussed previously, the FDA heavily regulates the promotion of off-label use of medication, and TikTok’s community guideline clearly states that videos regarding unhealthy weight loss methods are prohibited. Nevertheless, the videos discussing the off-label use of Ozempic are increasingly popular. Creators have the potential to profit from these videos through the TikTok Creator Fund. Beyond regulatory concerns, there are also ethical concerns with the discussion of Ozempic usage for weight loss. According to the literature review, TikTok is extremely popular among teenagers. Videos of this nature, with little regard for educating the audience about the risks of off-label use, can be extremely dangerous for young minds who cannot distinguish between social media and fact. Although these videos were likely not created with malice, there is still cause for concern when considering the nature of the discussion. Further research should be conducted to understand this dilemma better and potentially protect consumers from accessing improperly regulated information.
Although the examination of 160 videos provided important insights into the characteristics of content associated with Ozempic, a larger sample size with demographic information would likely yield a more comprehensive understanding of the available material and its nuances. Furthermore, the application of a deductive qualitative framework in this study may have imposed certain limitations on the analysis. Considering the inherently unstructured nature of video data, adopting an inductive, qualitative approach could prove more advantageous. This alternative methodology would facilitate the identification and emergence of themes during the data analysis process, thereby enriching the findings and contributing to a more nuanced interpretation of the content.