Semaglutide (aka Ozempic® and Wegovy®), a GLP-1 agonist, and tirzepatide (aka Mounjaro® and Zepbound®), a combined GLP-1 and GIP agent, are the latest rage in weight loss medications approved by the FDA. They were originally developed for the management of type-2 diabetes. Since being approved for weight loss, there has been a huge demand for these medications, so much so that the pharmaceutical companies have not been able to meet the medical needs of the public. In the interest of public health and meeting patient demands, FDA has allowed these patented medications to be produced by designated sterile compounding pharmacies as discussed below. Both semaglutide, better known as Ozempic® and Wegovy®, and tirzepatide, marketed as Mounjaro® and Zepbound®, in many cases facilitate weight loss without effort.
The fact that the use of these drugs can be effective and mindless is both a blessing and a curse. Both semaglutide and tirzepatide are effective in facilitating weight loss by cutting hunger and cravings plus promoting a variety of favorable metabolic and physiologic changes in the body. They also target and burn belly fat, which is extremely desirable for both esthetic and health reasons.
A major problem with their use is that once the medications are stopped, both the cravings and the weight come back unless sustainable changes in day-to-day food selections and lifestyle have been implemented. Taking semaglutide or tirzepatide without instituting the changes that actually address the root cause of why people gain weight in the first place is like putting air in a flat tire that’s deflated because it has a nail in it. You can pump it up but unless you fix it, it will not hold air for the long term.
The root cause of why most people gain weight is a direct consequence of the everyday food choices they make. These choices are in effect the spark that ignites a cascade of physiologic changes and behaviors that trigger overeating and progressive weight gain. It is the weight gain or more accurately put, increase in body fat (the most dangerous being belly or visceral fat), that provokes a condition known as insulin resistance, causing insulin levels to rise in an attempt for the body to control blood sugar. Increasing insulin levels impair our ability to burn fat while increasing fat production and storage, making it increasingly more difficult to lose weight and reverse the health consequences of being overweight.
Consequently, in the US, 70% of adults are overweight and 40% are obese. Additionally, 70% of illnesses in this country are a direct consequence of being overweight. That’s why it’s so important to identify and address the root cause of why people eat excessively and gain weight. Living a sedentary lifestyle does make the situation more challenging, but it contributes to only about 10% of the problem, with 90% being directly related to eating ultra-processed high glycemic pro-inflammatory ready-to-eat foods.
Semaglutide and tirzepatide are excellent choices for many to help facilitate weight loss if deemed appropriate by an experienced medical practitioner. FDA guidelines are clear; in order to be eligible to take either medication you must have a Body Mass Index (BMI) of 30 or more, or alternatively have a BMI of 27 to 29.9 plus have a cardiometabolic risk factor such as hypertension, type-2 diabetes, high triglycerides or significantly increased abdominal girth to name a few.
In either case, there are medical conditions that may prohibit their safe use. Semaglutide or tirzepatide should not be used if you or a family member have had a rare form of thyroid cancer known as Medullary Thyroid Cancer or Multiple Endocrine Neoplasia Syndrome Type-2. Caution should be taken with a history of pancreatitis, active gallbladder disease, severe depression, or kidney failure. It’s super important to acknowledge that both semaglutide and tirzepatide are real pharmaceutical medications and they should be used under strict medical supervision. If used properly, they are believed to be safe, but patients should be carefully monitored during use by an experienced medical practitioner.
Unfortunately, because of public demand, many people who have a bona fide medical need for semaglutide or tirzepatide are unable to get them from their local pharmacy. Currently, both medications are on FDA’s national shortage list. This enables physicians and other licensed medical practitioners to prescribe and dispense them when they are produced and provided by sterile compounding pharmacies.
Not all compounding pharmacies and practitioners follow current standards of care and best practices as recommended by FDA, CDC, World Health Organization and the Florida Board of Medicine. Many uninformed and way too often unscrupulous medical practitioners, weight loss centers and compounding pharmacies have taken advantage of the huge demand for semaglutide and tirzepatide and have been selling them as a commodity without following the guidelines set by FDA, CDC and the Florida Board of Medicine. As a consumer, it is nearly impossible to become aware of these recommended best practices, let alone evaluate who’s compliant and who’s not. Consequently, many people who fall victim to these unscrupulous practices are unnecessarily putting themselves at risk.
TIPS When Considering Compounded Semaglutide or Tirzepatide: Exercise Caution
When considering compounded semaglutide or tirzepatide, exercise caution and consider the following:
- Get a full medical evaluation from a bona fide medical practitioner, preferably someone who specializes in medical weight loss or endocrinology.
- Baseline bloodwork should be obtained.
- Ask questions and verify the answers.
- Unless a medication vial specifies otherwise, once a vial is pierced, it is only good for 28 days regardless of the expiration date on the vial. It has been reported to me that many practitioners provide patients with a large medication vial and tell their patients it can be used for 2 or 3 months. This is a clear violation of CDC and WHO recommendations and best practices. The sterility and potency of the medication should be considered compromised after 28 days from the day the vial is pierced unless the medication vial specifies it can be used beyond the 28 days. The expiration date is the UNPIERCED best used by date.
- Medical Practitioners are NOT allowed to sell medications or vary the price of the visit based on a medication dose in Florida per the Florida Board of Medicine. Semaglutide or tirzepatide must be provided as part of a comprehensive weight loss program with a set charge independent of the medication dose, otherwise the practitioner is in violation of the Florida Board of Medicine.
- It is extremely important that patients NEVER receive or accept prefilled syringes from a clinic or practitioner that preloads injections for later use. The use of prefilled syringes is a violation of accepted medical practices as well as the Florida Board of Medicine.
- Per FDA, compounded semaglutide and tirzepatide must be an exact duplicate of those medications approved by FDA. Many compounders fail to comply with this requirement. That is why it is critical that a trusted, credible, reputable, and knowledgeable medical provider performs the appropriate due diligence regarding the selection of the compounding pharmacy.
- The two types of sterile compounding pharmacies that are allowed to produce semaglutide and tirzepatide each have clear limitations as to who can get the medications and how they can be provided to patients.
- Office Use Only, 503b Compounding Pharmacies are pharmacies held to the highest standards and are inspected by FDA for compliance. They may be dispensed only in a medical facility and may be administered to multiple patients that come to the clinic. The semaglutide and tirzepatide from 503b Compounding Pharmacies are specifically not for at-home use. To be sure, the medication vial should be labeled ‘For Office or Institutional Use Only.’
- Patient Specific or 503a Compounding Pharmacies can only compound medications intended for the use of the specific patient whose name appears on the bottle label. That means once the prescription is written, this pharmacy produces the medication specifically only for the person for whom the prescription was written. No one other than the person whose name appears on the bottle can receive that medication. It may be taken home and used by only that specific patient.
- Medical research studies have documented the safest and most effective protocols for the administering of semaglutide and tirzepatide. Many practitioners and weight loss centers do not disclose their actual protocols, which often deviate substantially from the research. Some camouflage the dose by telling patients how many ‘units’ of a medications they are receiving. The approved protocols are specified in ‘milligrams’ and not ‘units’ of the medication. It is important to know the exact concentration of the compounded medication in order to determine how many milligrams are being dispensed and injected. Otherwise, the patient is not informed of the actual dose they are receiving. If you don’t know what you are getting, how can you determine if you are getting what you are supposed to, let alone know what you are paying for and if it’s safe? This is relevant particularly if you are not getting the clinical response that you had hoped for.
All of these tips are tedious and nearly impossible for any one person to unravel and evaluate.
As an alternative to compounding, you can obtain brand named semaglutide, Ozempic® and Wegovy® or tirzepatide, Mounjaro® and Zepbound®, directly from your pharmacy, with a prescription, if available. For most people these medications are unaffordable, costing from $1,000 to $1,300 per month. Unless you have Type-2 Diabetes most insurance companies don’t provide coverage and some discontinue coverage once the diabetes is resolved. Even if there is coverage, these medications may not be available since there is a national shortage. This shortage is why FDA is allowing both semaglutide and tirzepatide to be compounded, despite being under patents.
In summary, it’s best to select a trusted medical provider experienced in using these medications and ask lots of questions so you can make an informed decision about what is best for you.
Find out how CardioMender, MD can help you safely make the most appropriate choice for you.
