As a cardiologist obesity I often encounter patients who would greatly benefit from a new generation of weight loss drugs that act as glucagon-like peptide 1 (GLP-1) agonists.inside Recently published SELECT trial For example, the result Semaglutide (marketed by Novo Nordisk as Wegovy as a weight loss drug and as Ozempic as a type 2 diabetes drug) has been shown to increase the risk of heart attack and stroke by 20% in overweight and obese people without diabetes and with cardiovascular disease. % reduction, establishing its position as a drug that improves cardiovascular disease.people who don’t have type 2 diabetes.
Unfortunately, the high demand for these new weight loss drugs has led to frustrating and long-term shortages. The makers of two FDA-approved drugs, Novo Nordisk and Eli Lilly (Tirzepatide, sold as Zepbound for weight loss and Mounjaro for type 2 diabetes), are struggling to meet overwhelming demand. .
To ensure continuity of patient care, federal law requires compounding pharmacies tobasically copyOf the drugs listed as “currently in short supply” by the U.S. Food and Drug Administration: (FDA) Drug Shortage List.with semaglutide Tirzepatide It’s on that list. These drugs could be a lifeline for Americans struggling with obesity and other weight-related diseases.
Nevertheless, the medical community has widely criticized the use of compounded GLP-1 agonists, even when obtained from trusted, legitimate compounding pharmacies.
Yes, high demand has led to the emergence of unregulated companies and scammers who manufacture substandard or counterfeit versions of these medicines.
FDA discovers fraudulent products (masquerading as weight loss drugs) Warning statement To stop the distribution of illegally sold semaglutide. “These drugs may be counterfeit, meaning they contain the wrong ingredients, contain too little, too much, or no active ingredient, or contain other harmful ingredients. There is a possibility that it warns. Some products use the similar-sounding semaglutide sodium salt, but its safety and efficacy have been uncertain and have prompted warnings from the FDA and state pharmacy boards.
Many of these products are sold directly to consumers online through websites and social media with little or no medical oversight. This practice is of serious concern and discouraged as it can impact patient safety.
However, according to statement According to the Alliance for Pharmacy Compounding (APC), it is not legitimate compounding pharmacies that are selling these questionable products on the black market, especially online. This illegal activity has received media attention and is sometimes mistakenly associated with legal pharmacy compounding.
In contrast, legal and certified versions of GLP-1 agonist drugs are available from well-regulated and trusted compounding pharmacies. These pharmacies must comply with all federal and state regulations and only dispense medications with a valid prescription from a licensed physician.
Meanwhile, Novo Nordisk and Eli Lilly are suing compounding companies in multiple states, questioning the purity and efficacy of some compounded products, among other things, according to a statement from APC.
Compounding pharmacies have different designations: 503A and 503B. 503A are state-licensed pharmacies and physicians, and 503B pharmacies are outsourced facilities that are federally regulated and highly regulated by the FDA.this regulationestablished in response to the fungus incident in 2012 meningitis Outbreak coordination with compounding pharmacies ensures better quality control and monitoring, especially for medicines intended for intravenous or epidural use. These standards exceed those required for subcutaneous injections such as GLP-1 analogs.
Faced with this western climate where compounded drugs can vary in source, formulation, potency, and purity, the Obesity Society, Obesity Medicine Society, and Obesity Action Coalition Joint statement The report recommended against the use of formulated GLP-1 agonists, citing safety concerns and lack of regulatory oversight.
Although this posture is intended to ensure patient safety, it can inadvertently cause serious problems.
Experts say that by rejecting compounded drugs altogether, they could inadvertently encourage a black market and benefit from these drugs, contrary to the intent of federal law’s exemptions for compounding during drug shortages. may ignore the needs of patients who have sexual needs. Indeed, the presence of unreliable suppliers highlights the need to direct the public to reliable sources rather than imposing a blanket ban on medically appropriate alternatives.
The joint statement calls the combined GLP-1 agonist a “counterfeit product.” This inaccurate overgeneralization likely stems from a misunderstanding of the compounding process and its regulation. Genuine regulated pharmacies formulate GLP-1 agonist-based formulations, which are “essential copies” of FDA-approved drugs and are not counterfeit products. Recognizing this is important to maintaining trust in both pharmacies and regulators.
While it is true that “the only FDA-approved manufacturers of these drugs are Novo Nordisk and Eli Lilly, the companies that developed the active pharmaceutical ingredients,” the joint statement does not allow for the formulation of branded copies. There is no mention of exemptions provided by the law. Medicines on the shortage list.
Compounding pharmacies must obtain active pharmaceutical ingredients (APIs) from FDA-registered facilities that must adhere to current good manufacturing practices (cGMP). This ensures the quality, potency, and purity of the API, which is critical to the safety and efficacy of compounded medicines.
Combination drugs are not FDA approved and are not inherently safe. Complex drugs contain important drugs such as resuscitators and antibiotics and are often used in medical settings, especially when they are in short supply. This raises the question of why formulated GLP-1 agonists would be treated differently in such a scenario.
Additionally, when it comes to alternative drugs for obese patients at high risk for cardiovascular disease, FDA-approved brand-name alternatives may be more of a concern than compounded GLP-1 agonists. The Obesity Society advises people to echo the experts, saying, “If a GLP-1-based treatment is not currently available or available, there are other treatments available.” Although the statement does not specify the names of alternative drugs, experts recommend using alternative drugs such as Qsymia and Contrave despite potential cardiovascular concerns. This public recommendation may not represent a responsible risk-benefit analysis.
Rather than outright banning GLP-1 combination drugs, professional societies can contribute to the solution by creating a “seal of approval” that recognizes high-quality combination drugs. This contributes to informed decision-making for clinicians and patients.
possible solution
When prescribing GLP-1 agonists for obesity treatment, physicians should consider all of the following steps to ensure patient safety and effective treatment.
Prefer FDA approved brands: FDA-approved branded GLP-1 agonist drugs should be the first choice because of their established safety and efficacy.
Risk benefit analysis of non-FDA approved products: If an FDA-approved option is not available, your doctor may consider prescribing a copy of a brand-name drug that is not FDA-approved. Prior to this, perform a thorough risk-benefit analysis with the patient and fully educate them about the potential risks and benefits of using a product that is not FDA-approved.
Selecting a copy of semaglutide in certain cases:In patients with obesity and cardiovascular disease, the benefits of using a combined copy of semaglutide with cardiovascular disease-modifying properties compared to other FDA-approved anti-obesity drugs that may pose cardiovascular risks. may outweigh the risks compared to no anti-obesity treatment. all.
Informed consent and monitoring: Obtaining informed consent from patients is recommended when prescribing non-FDA-approved versions of GLP-1 agonists. We need to make people aware of the difference between the FDA-approved and non-FDA-approved versions.
503A and 503B pharmacy selection: Prescriptions for non-FDA-approved GLP-1 agonists can be sent to a 503A or 503B compounding pharmacy. However, it is a good idea to check whether the product can be dispensed at a 503B pharmacy. 503B pharmacies are subject to an additional layer of FDA regulation and offer greater quality assurance.
Clear prescription specifications: Make sure your prescription clearly states that the GLP-1 agonist being compounded should be the base compound without any excipients.
Request a certificate of analysis: For added safety, request a certificate of analysis from your dispensing pharmacy. This provides detailed quality and configuration information about the product.
Continuous monitoring: Continue to monitor the patient’s response to the drug, adjust the treatment plan as necessary, and continue regular follow-up.
Following these guidelines will help physicians navigate the complexities of prescribing GLP-1 agonists in a manner that prioritizes patient health, especially in scenarios where conventional treatment options are limited.
Dr. Eldad Eynaf is a board-certified cardiologist and diplomat with the American Board of Obesity Medicine. He is a Fellow of the American College of Cardiology and a member of the Obesity Medicine Society. He is the medical director of cardiometabolic health at Guthrie Lourdes in Binghamton, NY, and he is also the founder of myW8/cardiometabolic health in Beverly Hills, CA.
This article reflects only the personal views of Dr. Einav should not be construed as representing the official position of Guthrie Lourdes. Dr. Einav served as his speaker for Novo’s Nordisk promotion in 2022. At this time, in his practice, he does not prescribe combination drugs with GLP-1 agonists.
