The United States has become increasingly heavier over the past half century — overall obesity rates have increased three-fold since the 1960s. Currently, more than two-thirds of U.S. residents are now, by definition, overweight with those individuals qualifying as obese making up more than 40 percent of the population. Even more disturbing is the fact that one in ten individuals meet the medical criteria for a person who is morbidly obese, which can be a life-threatening condition if not counteracted by a change of diet and exercise.
Sadly, this increase in national obesity hasn’t happened overnight; in fact, it’s been a gradual and relentless process that has seen the number of overweight individuals in this country tripling over the past 60 years. Furthermore, the incidence of severe (morbid) obesity has increased ten-fold since the 1960s, and shockingly the figures may actually be an underestimation of this nationwide problem. Here in Maryland, the obesity rate is slightly below the national average at 34.3 percent as of 2021, but that is hardly any consolation.
With such a large number of overweight individuals in the U.S., dieting and nutritional advice has become big business over the past several decades. So many people, hoping to shed excessive weight quickly and with less effort, have fueled an entire industry of weight loss programs, supplements and prescription drugs. Enter Semaglutide, an FDA-approved pharmaceutical marketed by Novo Nordisk under several different brand names, which is being used to help patients with Type 2 diabetes and chronic obesity. This latest answer to the country’s obesity epidemic has shown great promise since its introduction several years ago, but as with many medications there are potential pitfalls and dangers facing those who take advantage of this breakthrough drug.
Available under the brand names of Ozempic, Wegovy and Rybelsus, semaglutide can be taken as an injectable (Ozempic and Wegovy) or orally (Rybelsus). As a glucagon-like peptide-1 (GLP-1) receptor agonist, semaglutide mimics GLP-1 and binds to GLP-1 receptors; this lowers blood glucose in one of two ways. 1) It stimulates the release of additional insulin by the pancreas, as it enhances the growth of pancreatic beta cells; 2) By inhibiting production of the body’s own glucagon, it reduces the release of stored carbohydrate via the liver (known as glucogenolysis) as well as the creation of new glucose (referred to as gluconeogenesis).
As an additional benefit for over weight individuals, GLP-1 receptor agonists cause a delay of gastric emptying, resulting in a feeling of fullness which then helps the patient to curb his or her caloric intake; Semaglutide does this by targeting certain areas of the human brain that control appetite, typically leading to increased satiety and ultimately weight loss itself. By reducing a patient’s appetite, as well as lowering his or her blood sugar, semaglutide has another important benefit: risk reduction for some types of heart-related conditions.
It should be noted that Ozempic, Wygovy and Rybelsus are not one-time use drugs. In fact, once on a semagutide regimen, most patients will need to continue to take the drug in order to maintain the weight loss attained through its initial use. When recommending a semaglutide-based drug, doctors will typically remind patients that doing so is not a short-term solution since a rebound (weight gain) will often be seen in those people who discontinue treatment.
One of the dangers associated with the use of these semaglutide-based drugs is the possible risk of thyroid cancer; this is based on the FDA labeling included with the medications’ packaging. Should a patient be interested in following a semaglutide regimen, their doctor will likely rule out the drug if the patient or a close relative has a known history of multiple endocrine neoplasia type 2 (MEN2), a rare inherited condition that can increase the risk of medullary thyroid cancer, also referred to as MTC.
Unfortunately, a significant barrier for patients looking to lose weight or treat their Type 2 diabetes, is the cost of these drugs. Without the benefit of insurance, many patients can face a monthly bill for these brand-name medications approaching $1,000. This can be a very stiff price to pay for lower income individuals, and sometimes even for those of more modest means.
One approach that has become common with those on a limited budget when looking for a proven weight loss drug is to use the services of a compounding pharmacy to create a somewhat cheaper version of Ozempic or Wygovy. There are many outlets on the Internet that advertise semaglutide compounds as weight loss products, but most, if not all of these compounding operations are neither FDA approved nor regulated, which should be a red flag for safety-conscious consumers.
Of course, accredited compounding pharmacies can be very helpful to patients who suffer from allergies to certain medications or drug groups, such as Sulfonamides. In such cases, for individuals with allergies or severe sensitivities, a compounding pharmacy can often create a specific medication tailored to that person’s individual requirements. But, while compounding pharmacies fill an important niche within the pharmaceutical industry, serious safety issues can arise, especially in cases when the compounded medications produced are not FDA tested or approved.
In regard to semaglutide-based compounded medications available online and from local compounding pharmacies, the Federal Drug Administration issued an important warning this past summer following reports of adverse events arising from the use of injectable semaglutide products. Some of the patients required hospitalization as a result of possible overdoses, which could have been the result of dosing errors associated with the compounded injectables.
Apparently, the ER admissions resulted mainly from patients self-administering an incorrect dose of semaglutide-based product, as well as doctors and other healthcare professionals having miscalculated the proper dose for the compounded semaglutide-based drug. In some instances, patients simply lacked experience related to the use of self-injected drugs, which included lack of experience with the process of filling the hypodermic syringe with the medication; as well as unfamiliarity with the measurements involved in preparing the proper dose.
As a result of the flurry of adverse events, the FDA has encouraged medical professionals and compounders to supply their patients with proper syringes sized for the intended semaglutide dose, as well as offering patients counseling on how to correctly measure out the proper dose. The FDA has also warned doctors and other healthcare professionals to be careful when prescribing semaglutide-based medications due to the possible variability of drug concentration.
Medication Dosing Errors May Lead to Personal Injury Lawsuits
It would appear that many of the errors associated with compounded semaglutide-based medications happened because of dose miscalculation, according to the July 2024 warning. While FDA-approved semaglutide injectables, which come in pre-filled hypodermic pens and are dosed in milligrams with standardized concentrations, compounders were providing semaglutide injectable products in a variety of concentrations at the time the warning was issued.
Several reports provided to the FDA described how doctors themselves had incorrectly calculated the recommended dose when converting from milligrams to units or milliliters. In some instances, patients ended up administering a dose five- to 10-times greater than the intended amount of semaglutide. The patients who overdosed as a result suffered from nausea and severe vomiting. Other negative effects can include abdominal pain, fainting, headache, migraine, dehydration, acute pancreatitis, gallstones, and severe hypoglycemia.
Furthermore, the FDA reported that some compounders added other ingredients into their semaglutide products — this included vitamins B-12 and B-6, L-Carnitine and nicotinamide adenine dinucleotide (NAD) added into semaglutide products. The FDA warned that the effect of combining vitamins and other compounds with semaglutide could not be known since the safety and effectiveness of those combinations had not yet been studied.
In addition, the FDA also learned that some compounded semaglutide products may have been created using salt forms of the drug, such as semaglutide sodium and semaglutide acetate. These salt forms have active ingredients which are different than those of the FDA-approved drugs. It would appear, based on the FDA warning, that there may not be a scientific basis for using the salt form of semaglutide for a compounded injectable.
Obtaining Monetary Compensation for Your Pharmacy-related Injuries
As personal injury specialists, the attorneys at Lebowitz & Mzhen, LLC, know all too well that, under certain circumstances, the consequences of incorrect dosing can be quite serious, if not potentially deadly. Medications created to improve a patient’s quality of life can actually hasten their death if the ensuing symptoms are not recognized and corrected by a doctor in a timely fashion.
Whether it’s the administration of the wrong drug or receiving an incorrect dosage of the proper medication, the results can be devastating. In some situations, a prescribing error or pharmacy misfill can be fatal, opening the door to a possible wrongful death claim.
Medication errors and misfilled prescriptions can occur when a pharmacist neglects his or her obligation to follow basic rules of pharmacology when filling, verifying and delivering patient prescriptions. Unfortunately, corporate chain pharmacies tend to emphasize the meeting of daily or weekly prescription quotas as opposed to maintaining a high standard of quality and safety for their patients’ benefit.
The establishment of quotas by large, profit-oriented corporations often has a negative effect on pharmacy employees by causing workday stress and fatigue, both of which can affect the pharmacist’s concentration, ultimately leading to potentially deadly mistakes when preparing patients’ medications. Worse yet, because the prescription-filling process often involves multiple individuals — pharmacists, pharmacy clerks and technicians, as well as other pharmacy staff — there exist many opportunities for errors.
If you or someone you care about has suffered a medication-related injury believed to be the result of a a pharmacy error or prescribing mistake, the personal injury experts at Lebowitz & Mzhen, LLC, are here to help. Our legal team has represented numerous victims of medical malpractice and pharmacy mistakes throughout the state of Maryland and the District of Columbia. To better understand your legal rights, call our offices toll free at (800) 654-1949 to arrange a no-cost initial consultation; or, if you prefer, you can contact Jack Lebowitz or Vadim Mzhen via email as well.