The Dangers of Counterfeit Weight Loss Drugs and Rapid Weight Loss in Seniors
by Don Drake, Connelly Law Offices, Ltd. 7.15.24
"Ozempic and other medications containing semaglutide, initially used for treating diabetes, have gained popularity as weight loss drugs among celebrities, tech moguls, and so-called TikTok influencers," said Attorney RJ Connelly III, professional fiduciary and certified elder law attorney, "The higher-dose version of the medication, approved by the FDA for treating obesity under the brand name Wegovy in 2021, has contributed to this trend. However, the surge in popularity has resulted in a shortage of the medication, leading to the emergence of counterfeit weight loss drugs that can have serious adverse health effects for young and old alike."
Newspaper reports indicate that counterfeit weight-loss drugs using semaglutide have caused the hospitalization of three people and the death of two individuals in the United States. The FDA is closely monitoring these incidents through its FAERS system, although the reports have yet to be verified. It is important to note that the manufacturers of Ozempic and Wegovy have submitted these cases to FAERS.
"We had previously done a blog regarding concerns of fake products hitting the market and the results they could have upon seniors, and on June 20, the World Health Organization (WHO), issued its first official warning concerning the proliferation of fake versions of the widely used drug Ozempic," said Attorney Connelly. "Counterfeit varieties of this medication were first detected in Brazil in October 2023, followed by discoveries in the United Kingdom and Northern Ireland in the same month, and in the United States in December 2023. Concerns have been raised over the potential inclusion of undisclosed harmful substances, notably insulin, in these fake medications and injection devices, which could result in severe health risks or complications."
Weight Management is More Than Drugs
Weight management is a complex process involving 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, known as the "starvation response." This response makes it challenging to maintain weight loss in the long run. Additionally, when we lose weight, our brain makes our muscles more efficient, burning fewer calories for the same activities.
Medical science has made significant progress in helping people manage their weight more effectively. The FDA has approved multiple weight loss drugs for long-term obesity treatment, which include Orlistat (Xenical), phentermine-topiramate (Qysmia), naltrexone-bupropion (Contrave), liraglutide (Saxenda), semaglutide (Wegovy), setmelanotide (IMCIVREE), and tirzepatide (Zepbound), which work by reducing cravings, suppressing thoughts of food, and preventing binge eating. These medications offer new hope for individuals struggling to manage their weight and improve their overall health.
However, weight management requires an integrated approach beyond just taking medication. Combining medication with exercise, healthy eating habits, and lifestyle changes can significantly improve weight loss outcomes and help individuals maintain their weight loss in the long term.
What is Counterfeit Ozempic
Counterfeit drugs have been an increasing issue in the pharmaceutical industry, with incidents such as the discovery of a counterfeit Ozempic pen in a U.S. pharmacy, leading to adverse reactions in patients. The British Medicines and Health Products Regulatory Agency reported seizing 369 potentially fake Ozempic pens since January 2023. Reports have also surfaced regarding counterfeit Saxenda pens in Europe.
"Online pharmacies have turned to drug compounding to create weight-loss drugs, which are not FDA-approved and can be harmful," stated Attorney Connelly. "Compounding pharmacies, medical spas, wellness clinics, and weight loss centers are all involved in producing these compounded drugs."
To address this, Novo Nordisk, the manufacturer of semaglutide products, is taking legal action against med spas, weight loss clinics, and compounding pharmacies. Additionally, they aim to reinforce the responsible use of their FDA-approved medications to protect patients from counterfeit and compounded semaglutide products claiming to contain semaglutide.
What is Compounding
Drug compounding involves modifying or combining a drug's ingredients to create customized medication to cater to individual patient needs. Recent reports have highlighted concerns about some compounding pharmacies mixing the dangerous salt form of semaglutide into weight-loss drugs like Ozempic and Wegovy, leading to legal actions against the clinics and pharmacies involved in selling these compounded semaglutide products.
According to "Everyday Health," compounding pharmacies are permitted to operate with limited oversight from the FDA in order to produce tailored medications for patients with unique requirements. However, there are instances where these pharmacies have expanded their operations beyond traditional compounding, resembling large-scale manufacturers, as indicated in a 2013 review.
The FDA has raised alarm about this practice, stating that it extends beyond the boundaries of traditional pharmacy, posing risks of contamination and producing products that do not meet the required standards of strength, quality, and purity. Despite these warnings, some telehealth doctors continue to prescribe compounded semaglutide and tripeptide, with support for their safety and efficacy being advocated on platforms like TikTok and YouTube. This issue has caused a division in the online community, with some groups strictly prohibiting any discussion about compounded drugs. In contrast, others are dedicated to sharing information about their acquisition and usage.
Even the "Legitimate" Versions Carry Risks
When using prescription weight loss medications, there are potential risks, especially for individuals who do not have a medical need for them. Rapid and significant weight loss, particularly exceeding thirty-five pounds in less than six months, can adversely affect the body, including muscle loss, nutritional deficiencies, and reproductive health complications. Additionally, the depletion of essential nutrients and vitamins over a short period can lead to changes in the skin, such as loss of elasticity and radiance, as well as a gaunt and aged appearance due to a loss of volume in the cheeks.
Furthermore, a study suggests that individuals using popular weight loss medications like Ozempic, Wegovy, and Saxenda may have a higher risk of stomach problems compared to those using other weight loss drugs. Specifically, individuals taking medications containing semaglutide, liraglutide, or Contrave may be at a higher risk of developing pancreatitis, bowel obstruction, and gastroparesis. These findings highlight the importance of considering the potential risks and consulting with a healthcare professional before using such weight loss medications.
Seniors and Rapid Weight Loss
"It's important to be mindful of potential risks when considering weight loss, especially for older individuals," Attorney Connelly points out. "As weight is lost, approximately 25% comprises muscle and bone mass. This is particularly concerning for older adults with lower levels of both."
Weight loss can also contribute to bone loss, increasing the risk of osteoporosis in older adults. Medications to reduce appetite may result in deficiencies in essential nutrients such as vitamins, proteins, and minerals. Furthermore, unintentional ongoing weight loss is common in older individuals, which can give rise to additional systemic issues.
Sensible eating and maintaining a healthy weight were underscored as key recommendations. Additionally, medical professionals stressed the importance of thoroughly discussing any weight loss program's potential risks and benefits before recommending it to seniors. They also cautioned that rapid weight loss in older adults can heighten susceptibility to various health issues and complications, potentially worsening existing conditions.
A Final Word
"Medical professionals stress that when using medications containing semaglutide, it is crucial to obtain them with a valid prescription from a licensed healthcare provider and to purchase them from state-licensed pharmacies or FDA-registered outsourcing facilities," said Attorney Connelly. "The FDA continues to advise against buying medication from unregulated sources online, as it poses the risk of exposure to potentially unsafe products. Prioritizing safety by obtaining drugs from legitimate sources is essential to ensure the efficacy and safety of the medication."
Please note that the information provided in this blog is not intended to and should not be construed as legal, financial, or medical advice. The content, materials, and information presented in this blog are solely for general informational purposes and may not be the most up-to-date information available regarding legal, financial, or medical matters. This blog may also contain links to other third-party websites that are included for the convenience of the reader or user. Please note that Connelly Law Offices, Ltd. does not necessarily recommend or endorse the contents of such third-party sites. If you have any particular legal matters, financial concerns, or medical issues, we strongly advise you to consult your attorney, professional fiduciary advisor, or medical provider.
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