The ‘Skinny’ on Ozempic: Are Off-Label Prescriptions the Newest Diet Trend?

By Gianna Costello, JHBL Staff Member

South Beach, Intermittent Fasting, Paleo, Keto – diet fads seem to renew with the seasons. The latest in these diet fads is Ozempic. Ozempic is an FDA approved injectable medication used to manage Type 2 diabetes. The drug rose to fame for its off-label use as a weight loss medication, which is especially popular among celebrity crowds. The drug affects the hunger centers in the brain, reducing hunger and prolonging fullness after meals. Off-label users accomplish their weight-loss goals by using Ozempic to shed weight and to look “insta-worthy” in real life.

Off-label use of Food and Drug Administration [‘FDA’] approved drugs is an integral part of practicing medicine in the United States. The term “off-label” refers to prescribing an FDA-approved drug for a use which has not been approved by the FDA. This practice is perfectly legal because once a drug is FDA-approved, it can be used for any indication. Prescribing approved drugs for off-label use is not uncommon and is often necessary to treat ailments for which no FDA-approved drug exists. Off-label prescribing is so common, in fact, that it accounts for between 10-20% of all prescriptions written.

Off-label use of Ozempic is rampant. Users obtain prescriptions through physicians, nurse practitioners, medical spas, and some find the drug online. Off-label users are chasing ultra-thinness, and since weight loss is not Ozempic’s approved use, the long-term effects of such use are largely unknown. While legal, experts are wary of off-label use of Ozempic by those the drug is not intended for and are cautious of the potential of heightened side effects, which may include nausea, vomiting, diarrhea, and constipation. Some off-label users also experience symptoms of fatigue, a result of low caloric intake. Aside from side effects and potential long-term health consequences, the cost of Ozempic is steep, with off-label users paying hundreds or even thousands of dollars for a month’s supply of the so-called “miracle drug.”

Off-label users aren’t the only ones who are paying a steep price. Diabetics, in need of Ozempic for its FDA-approved purposes, are facing difficulties in obtaining the drug because of its intense popularity. Demand for the drug has soared over the last year, largely due to its off-label use for weight loss. This increase in demand caused a shortage of Ozempic, making it difficult for those who need it most to obtain the medication. Doctors are struggling to help their diabetic patients find the medication and, at times, they are unable to obtain even samples of the drug.

While off-label prescribing is legal, and sometimes even encouraged, this practice can result in dangerous consequences for off-label users who the medication was not intended for and for the people who have an approved medical need for the drug. A possible remedy to address these consequences is to increase regulations of off-label use of FDA approved drugs. Such regulation could be proffered by the FDA itself, specifically by collecting evidence and quantifying the possible harms of off-label drug usage. Further regulation of off-label prescribing could aid in preventing this practice from becoming the latest “hot diet” fad.

Disclaimer: The views expressed in this blog are the views of the author alone and do not represent the views of JHBL or Suffolk University Law School.

Sources:

The ‘Skinny’ on Ozempic: Are Off-Label Prescriptions the Newest Diet Trend?

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