Friday, June 14, 2024

Are Compound Weight Loss Medications Semaglutide and Tirzepatide Safe?

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As popular drugs Ozempic and Mounjaro have become part of the popular landscape, so have compound weight loss medications. While many individuals have face obstacles getting their medications approved by insurance, another option has come readily available. Compounded weight loss medications are specially formulated and offer an alternative for those seeking effective weight loss solutions when their prescription options are limited. Questions arise about their safety, effectiveness and composition compared to pharmaceutical brand names, so we tapped the experts to get a handle on this growing trend.

Insurance Coverage Challenges

Insurance issues have played a significant role in driving individuals to explore compounded weight loss medications as an alternative to pharmaceutical brand names like semaglutide and tirzepatide. New York endocrinologist Caroline Messer, MD highlights several insurance-related challenges that have prompted this shift. “Semaglutide has two FDA-approved versions: Ozempic and Wegovy. Ozempic is only approved for adults with type 2 diabetes, and Wegovy is only approved for weight management. The vast majority of patients with diabetes can obtain insurance coverage for Ozempic, but unfortunately, patients with borderline diabetes (prediabetes/insulin resistance) are excluded from coverage.” 

Even patients with confirmed obesity frequently learn that their insurance policies have preexisting plan exclusions which restrict the coverage of any weight loss medications says Dr. Messer. This has many patients and doctors switching to compounded semaglutide and tirzepatide.

Enter Compound Weight Loss Medications…But Are They Safe?

The safety and effectiveness of compounded weight loss medications remain a subject of debate and concern. Dr. Messer acknowledges that compounded versions of semaglutide and tirzepatide lack FDA approval. “There is no way to guarantee the safety, efficacy, or potency of these formulations,” Dr. Messer explains. 

Obesity specialist Dr. Spencer Nadolsky, medical director of WeightWatchers, emphasizes the lack of studies and absence of long-term randomized controlled trials raises significant concerns about patient safety. “There have been no studies assessing the safety or effectiveness of compounded versions of GLP-1 medications, which raises a significant concern. These compounds are not FDA-approved and have not undergone rigorous testing like the FDA-approved versions have undergone over many years in treating diabetes.” 

Composition and Ingredients

Compounding pharmacies create these weight loss medications using salt forms of semaglutide, such as semaglutide sodium and semaglutide acetate. These active ingredients differ from those found in FDA-approved drugs like Ozempic and Wegovy. “Compounding pharmacies use the salt forms of semaglutide including semaglutide sodium and semaglutide acetate. These are different active ingredients than those used in the approved drugs. This alteration may change the bioavailability and strength of the medication,” says Dr. Messer.

Compounded medications may include additional ingredients, such as B12 and L-carnitine, which are not present in the original pharmaceutical formulations. These added ingredients aim to enhance the medication’s effects or provide other benefits. However, the lack of standardized formulations and third-party testing raises questions about consistency and safety.

However, not all physicians have reservations about using compounded weight loss medications. New York plastic surgeon Sharon Giese, MD likes that some added ingredients help offset side effects like fatigue. “Many add an additional ingredient to differentiate it from the prescribed medication. I like B12 added for several reasons,” she says.

Success Stories and Guidance

Despite the concerns, some patients have reported success with compounded weight loss medications. Dr. Giese shares stories of patients who have achieved significant weight loss and experienced health improvements after switching to compounded versions.

“I’ve encountered several otherwise healthy but obese patients whose primary care doctor prescribed medication, only to find that their insurance did not cover it. Or some whose doctor would not write for the script because they ‘do not write for weight loss meds.’ I have helped many patients lose 40 to 60 pounds or more,” she says.

Compound Weight Loss Medications vs. Pharmaceutical Results

“Anecdotally, I have seen no difference in outcomes in my own practice after treating hundreds of patients with the compounded versions,” says Dr. Messer. “I place a strong emphasis on improving lifestyle and treating emotional eating for a more sustainable weight loss. For this reason, my practice employs a dietitian, two trainers and a psychologist. Since compounded medications lack insurance coverage, I encourage individuals to proactively set aside funds in health savings accounts for payment with pre-tax dollars.”

While some patients have reported positive outcomes, concerns about safety, effectiveness, and consistency persist. It’s important for patients to know these medications lack FDA approval and standardized formulations, making them a subject of debate among healthcare professionals. Individuals considering compounded weight loss medications should consult with their healthcare providers to make informed decisions about their weight loss journey. 

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