San Antonio Weight Loss Clinic Addresses Semaglutide Concerns Amidst FDA Regulations
San Antonio, TX – As the U.S. Food and Drug Governance (FDA) deadline for compound pharmacies to cease the production of compounded semaglutide took effect on May 22, a local weight loss expert is urging consumers not to be alarmed. Dr. Paula Bilica, owner of IMAXweightloss, believes pharmacies have anticipated this change and are prepared.
Understanding the FDA’s Decision
The FDA’s decision stems from the fact that name-brand products containing semaglutide, such as Ozempic and Wegovy, are no longer on the drug shortage list. Compounding pharmacies were previously permitted to create versions of these medications when the brand-name drugs faced supply constraints. Now that these shortages have eased, the FDA is enforcing regulations against the off-brand semaglutide due to its lack of formal FDA approval for weight loss.
Did You Know?
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. It mimics the effects of the GLP-1 hormone, which helps regulate blood sugar levels, slows down gastric emptying, and reduces appetite, leading to weight loss.
Expert Insight: Dr. Paula Bilica’s Viewpoint
Dr.Bilica emphasizes that pharmacies were well-informed about the impending deadline. The pharmacies knew this was coming, so they have a lot of medication they still have. So I think they are just playing the long game, waiting on the courts to see what officially happens,
she stated. She also suggests that the brand-name medications could perhaps return to the shortage list, which would again allow compounding pharmacies to produce semaglutide.
When any medicines are on a shortage list, the compounding pharmacies are allowed to make a copy of the medication. So semaglutide is the active ingredient in Ozempic and wegovy. Tirzepatide is the other active ingredient in Mounjaro and Zepbound.
Dr. Paula Bilica,IMAXweightloss
Potential Health Benefits Beyond Weight Loss
Dr. Bilica highlights the growing body of research indicating additional health benefits associated with semaglutide. There are also now many studies coming out where we know there are other health benefits, like decreased risk of cardiovascular disease, high blood pressure, cholesterol, addiction, sleep apnea, a lot of benefits,
she explained.
Pharmacies’ Current Strategies
Despite the FDA’s regulations,many pharmacies are continuing to operate without significant disruption. I spoke with several pharmacies because of my concern and the concern of my customers, but they said right now they are business as usual,
Bilica noted. She added that pharmacies are adapting by using different dosing strategies and incorporating supplements like B12 and B6 into their formulations to mitigate potential side effects and enhance energy levels. They are able to use a different dosing, and they would frequently enough add B12 (an essential water-soluble vitamin that plays a crucial role in various bodily functions) and B6 (a water-soluble vitamin essential for various bodily functions including metabolism, red blood cell creation and brain function.) to their formulation so it is a little different formulation to help with energy and nausea.Don’t hit the panic button yet.
Pro Tip
Consult with yoru healthcare provider before making any changes to your medication regimen. They can provide personalized advice based on your individual health needs and circumstances.
Navigating the Current Landscape: Options for Consumers
dr. Bilica outlines two primary options for individuals currently using semaglutide. The first is to switch to name-brand medications, which can be prohibitively expensive for many.Option A,they can buy the name brand medicine,which most people can’t afford,
she said. the second option involves discontinuing the medication and focusing on maintaining weight loss through diet and exercise. The second option is that you would have to go off the medicine, and hopefully, while you were on the medicine, you were using it as a tool to work on your nutrition and fitness. That way, if you do decide to come off of it, you can maintain on your own and just hope the name brand products would go back on shortage lists.
Looking Ahead
Given that a significant portion of the U.S. population struggles with obesity, Dr. Bilica expresses hope for a resolution that ensures affordable access to these medications. With 40% of Americans being obese, she is hopeful that things work out for the better with the FDA. we are good for a while. There is still a lot of litigation going on between big pharmaceutical companies and compounding pharmacies, and name-brand drugs could get back on shortage lists with this decision being made. But you shouldn’t have to afford $1,000 a month to be on medicine that can definitely help you overall in total help your health. I would like for them to come to an agreement so both can make it, and so everyone can have it.
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For more information on weight loss drugs and their impact on health, consider reading: Weight-loss drugs may lower cancer risk in people with diabetes, a study suggests.
