The Dangers of Using "Counterfeit" Weight Loss Medications
By Don Drake, Connelly Law Offices, Ltd.
"Ozempic, and other medications containing semaglutide used for treating diabetes, is becoming increasingly popular as a weight loss drug among celebrities, tech moguls, and TikTok influencers," according to professional fiduciary and certified elder law Attorney RJ Connelly III. "The FDA has approved a higher-dose version of the medication for treating obesity, under the brand name Wegovy, in 2021. Other weight loss medications, including pill versions, are also being developed. However, this popularity has led to a shortage of the medication, resulting in counterfeit weight loss products that can be dangerous and have adverse health effects. These effects are only now starting to be understood, as are the adverse effects of the real medication. But first, we are going to discuss the counterfeit products."
Counterfeit weight-loss drugs using forms of semaglutide in the United States have resulted in the hospitalization of three people and the death of two. The Food and Drug Administration (FDA) maintains a monitoring system known as FAERS that tracks medication side effects. According to official data, cases of adverse effects have been reported between July and September, but they have yet to be verified. All of the cases have been submitted to FAERS by the manufacturers of Ozempic and Wegovy. The reports of counterfeit Ozempic drugs in the United States are a cause for concern after regulators in the United Kingdom warned against fake versions of the drug that put users in a coma there.
Weight Management is More Than Drugs
Medical professionals point out that weight management is a complex process that involves our body's intricate systems. Our brain plays a crucial role in regulating our weight by defending against starvation and preserving the weight we have. The body's natural response to weight loss is to activate specific hormones that signal our brain to increase hunger and cravings while slowing down our metabolism. This response is called the "starvation response," and it makes it challenging to maintain weight loss in the long run. Furthermore, when we lose weight, our brain makes our muscles more efficient, which means we burn fewer calories for the same activities.
However, medical science has significantly progressed in helping people manage their weight more effectively. Weight loss medications that target appetite and hunger are now available by activating the hormones we naturally produce to regulate weight. The FDA has approved five different weight loss drugs for long-term obesity treatment, and these medications work by reducing cravings, suppressing thoughts of food, and preventing binge eating. By helping people feel full sooner and stay full longer, these medications offer new hope for individuals struggling to manage their weight and improve their overall health.
With this new knowledge, we must understand that weight management requires an integrated approach beyond just taking medication. Combining medication with exercise, healthy eating habits, and other lifestyle changes can significantly improve weight loss outcomes and help individuals maintain their weight loss in the long run.
What is Counterfeit Ozempic
Counterfeit drugs have become a growing concern in the pharmaceutical industry. One such incident occurred in June with Novo Nordisk, a renowned pharmaceutical company. The company reported a case of a counterfeit Ozempic pen found in a pharmacy in the United States. The counterfeit drug caused an adverse reaction in the patients who used it. In October, the British counterpart of the FDA, the Medicines and Health Products Regulatory Agency reported that it had seized 369 potentially fake Ozempic pens since January 2023. The company also manufactures Saxenda pens, and there have been reports of counterfeit Saxenda pens as well.
"One of the biggest concerns is that online pharmacies have turned to drug compounding to produce weight-loss drugs," stated Attorney Connelly. "Unfortunately, these compounded drugs are not FDA-approved and can be harmful. Compounding pharmacies, medical spas, wellness clinics, and weight loss centers are all involved in creating compounded versions of these drugs."
To protect patients from the unlawful marketing and sales of non-FDA approved counterfeit and compounded semaglutide products claiming to contain semaglutide, Novo Nordisk, the company that makes semaglutide (Ozempic, Wegovy, and Rybelsus), has announced that it is suing med spas, weight loss clinics, and compounding pharmacies while reinforcing the responsible use of Novo Nordisk's FDA-approved medicines.
What is Compounding
"Drug compounding is the process of altering or combining a drug's ingredients to create medication that meets the individual patient's specific needs," said Attorney Connelly. 'It has been reported, however, that some compounding pharmacies mix the dangerous salt form of semaglutide into weight-loss drugs like Ozempic and Wegovy. This has resulted in legal actions being taken against clinics and pharmacies that sell compounded versions of semaglutide products."
The website "Everyday Health" reports that compounding pharmacies are allowed to operate mainly without FDA oversight to create custom medications for patients with uncommon needs. Nonetheless, some pharmacies have turned into large-scale manufacturers to expand their activities beyond the scope of traditional pharmacy compounding, according to a 2013 review.
According to the site, this practice is "clearly outside the bounds of traditional pharmacy," warned the FDA, stating that compounding "can result in contamination or in products that don’t possess the strength, quality, and purity required." Despite this warning, many telehealth doctors knowingly prescribe compounded semaglutide and tripeptide, and both TikTok and YouTube host many videos of doctors and pharmacists arguing for their safety and efficacy.
There is a split in the online community regarding the matter. Some groups explicitly prohibit any mention of compounded drugs, while others are dedicated entirely to discussing their acquisition and use. It is not yet clear how Novo Nordisk's lawsuit may affect outlets providing compounded GLP-1 receptor agonists, stated Everyday Health.
Even the "Legitimate" Versions Carry Risks
Those who are using the "real" version of these drugs also face some risks. Diabetes Daily, an Everyday Health network site, reports that those using legitimate versions of these medications who do not have a medical reason to do so face potential risks such as muscle loss, nutritional deficiencies, and even reproductive health complications.
Dr. Michele Koo, a renowned plastic surgeon in St. Louis, explained to Everyday Health that losing a significant amount of weight in a short period of time, significantly exceeding thirty-five pounds in less than six months, can have adverse effects on the body's essential nutrients, endocrine system, and GI system balance. This sudden weight loss can lead to the depletion of the skin's vital nutrients and disrupt its natural elasticity and radiance.
Dr. Koo further explained that the body's collagen and elastin metabolism are also disturbed, resulting in thin, sallow, and dull skin. Additionally, the loss of volume or fat in the cheeks due to rapid and significant weight loss can lead to a gaunt and aged appearance. This depletion of nutrition and vitamins over a short period of time causes fat to reabsorb and atrophy, further compounding the adverse effects of rapid weight loss.
Dr. Koo stresses that the skin changes are primarily due to the depletion of essential nutrients and vitamins over a short period of time. She warns that people of average weight or who are only mildly overweight should avoid using weight loss drugs like Ozempic as they can lead to muscle loss and further fat loss in areas where there is not much excess fat.
There is also evidence that those who use these popular medications to lose weight may have a higher risk of severe stomach problems than they would have with some other weight loss medications, a new study suggests. Individuals who consume popular weight loss medications, such as Ozempic and Wegovy containing semaglutide or Saxenda containing liraglutide, may be at a higher risk of severe stomach problems compared to those who use other weight loss drugs. The study examined the health insurance claims data of around 5,400 people suffering from obesity, but not diabetes, who were prescribed medications containing semaglutide, liraglutide, or Contrave, an older weight loss pill that contains a combination of bupropion and naltrexone.
As per the study results published in JAMA, people who took Ozempic or the obesity drugs Wegovy and Saxenda were over nine times more likely to develop pancreatitis than those who consumed the older pill. Pancreatitis is a condition that leads to inflammation in the pancreas and can cause intense abdominal pain, often requiring surgery. The study also found that the new injectable weight loss medicines were linked to more than quadrupled risk of bowel obstruction and over tripled risk of gastroparesis or stomach paralysis, which can hinder the movement of food through the intestines.
Seniors and Rapid Weight Loss
Losing weight may seem like a good idea, but it comes with risks, especially for older people. As you lose weight, about 25% of it is muscle and bone, and older adults already have less of both to begin with. Excess belly fat can also cause a decline in muscle mass, which is more pronounced in people with obesity. Weight loss can also lead to additional bone loss, making older adults more prone to osteoporosis. Medications that reduce appetite can also cause vitamin, protein, and mineral deficiencies. Even more concerning is that unintentional ongoing weight loss is common in older individuals, leading to additional systemic issues.
"After consulting with multiple medical professionals, none of them recommended the use of semaglutide medication for weight loss in older adults," stated Attorney Connelly. "Although they all recommended sensible eating and maintaining a healthy weight, they warned that any weight loss program's potential risks and benefits need to be discussed before suggesting it to seniors. They added that rapid weight loss in older adults can make them more susceptible to various health issues and complications and could exacerbate existing conditions."
A Final Word
"If you are planning to use medications containing semaglutide, it is extremely important to purchase them only with a valid prescription from a licensed healthcare provider and acquire them solely from state-licensed pharmacies or outsourcing facilities registered with the FDA," Attorney Connelly warned. "The agency cautions that buying medicine online from unregulated and unlicensed sources can put consumers at risk of being exposed to potentially harmful and unsafe products. It is of utmost importance to prioritize safety and purchase drugs from legitimate sources to ensure the efficacy and safety of the medication."
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