glucagon-like peptide-1 (GLP-1) receptor agonists

Compounding Compounds the Problem

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Compound pharmacies that bulk produce weight-loss drugs without FDA approval are doing so without that oversight.  And because compounding pharmacies aren’t required to report instances of patient harm involving their medications, problems may go undetected.“It’s kind of like ‘Whack-A-Mole,’” said Al Carter, a pharmacist and executive director at the National Association of Boards of Pharmacy. He said state boards will only investigate when they receive a complaint.“There are bad actors out there, purporting to be compounding pharmacies that are licensed in specific states or have the credentials to be able to compound when in actuality they don’t,” said Carter. “My understanding is most licensed, legitimate pharmacies aren’t compounding” weight-loss medications. ‘Compounded’ weight-loss drugs are a growing problem for state regulators – https://stateline.org/2024/07/08/compounded-weight-loss-drugs-are-a-growing-problem-for-state-regulators/

A website sold patients obesity drugs at affordable rates. Now they’re paying the price.– https://www.npr.org/2025/02/08/nx-s1-5246124/a-website-sold-patients-obesity-drugs-at-affordable-rates-now-theyre-paying-the-price

“The two main goals of the medication are weight loss and diabetes management, so patients should stay on the lowest dosage possible until they feel like they’ve plateaued,” said Charu Sawhney, DO, MPH, an internal medicine physician with Harbor Health in Round Rock, Texas. When patients move up on the dosage too fast, they’re going to have more trouble, said Sawhney. “This is when we see the most severe side effects like the malnutrition and dehydration that can sometimes land patients in the hospital,” she said. Considerations for Prescribing GLP-1s Get More Complicated – Medscape – February 07, 2025 – https://www.medscape.com/viewarticle/considerations-prescribing-glp-1s-get-more-complicated

I admit as a Former Fat Man that the world of obesity and now a miracle drug to fight the disease fascinates the hell out of me. Caveat emptor!

Mind the Gaps – Update 11.10.24

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More good news since I posted Mind The Gaps.

On November 5, the US Food and Drug Administration (FDA) updated the labels for all glucagon-like peptide 1 receptor agonists (GLP-1 RA) with a warning about pulmonary aspiration during general anesthesia or deep sedation. The affected drugs are semaglutide (Ozempic, Rybelsus, Wegovy); liraglutide (Saxenda, Victoza); and the dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 tirzepatide (Mounjaro, Zepbound). FDA Updates GLP-1 Label With Pulmonary Aspiration Warning – Medscape – November 06, 2024. https://www.medscape.com/viewarticle/fda-updates-glp-1-label-pulmonary-aspiration-warning-2024a1000k84?src=rss

Interesting potential side effect. This is from the FDA on regulated GLP-1 RA drugs. But since I know a lot of you out there are using the compounded version…

https://www.medscape.com/s/viewarticle/novo-nordisk-aware-10-deaths-compounded-weight-loss-drug-2024a1000k8f?src=rss

Death is also a potential side effect of the FDA regulated version.

Susan McGowan, 58, took two low-dose injections of tirzepatide, known under the brand name Mounjaro, over the course of about two weeks before her death on 4 September.Her death certificate, seen by the BBC, lists multiple organ failure, septic shock and pancreatitis as the immediate cause of death – but “the use of prescribed tirzepatide” is also recorded as a contributing factor…There have been 23 suspected deaths linked to semaglutide in the UK via the yellow card scheme since 2019. Nurse’s death linked to approved weight-loss drug – https://www.bbc.com/news/articles/cz6jg6nw2zeo?

Yikes.

Mind The Gaps

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The Food and Drug Administration is warning consumers not to use any drugs made by a compounding pharmacy in California after regulators realized the pharmacy was making drugs that need to be sterile—particularly injectable drugs—without using sterile ingredients or any sterilization steps.

The products made by the pharmacy, Fullerton Wellness LLC, in Ontario, California, include semaglutide, which is intended to mimic brand-name weight-loss and diabetes drugs Wegovy and Ozempic. Fullerton also made tirzepatide, which is intended to mimic weight-loss and diabetes drugs Zepbound and Mounjaro. Drugmaker shut down after black schmutz found in injectable weight-loss drug — https://arstechnica.com/health/2024/11/drugmaker-shut-down-after-black-schmutz-found-in-injectable-weight-loss-drug/

I’ve read the FDA advisory. The FDA warns patients and health care professionals not to use compounded drugs from Fullerton Wellness — https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-patients-and-health-care-professionals-not-use-compounded-drugs-fullerton-wellness

  1. If you’re injecting what you believe is a weight loss medication do you pay any attention to who the manufacturer is?
  2. Do you read any of the FDA drug alerts and statements?
  3. The FDA names the compounding facility but does not name of any clinics or online purveyors who may be selling you tainted and non-sterile drugs.
  4. If you ask your online provider questions will you get honest answers?
  5. Is losing a few pounds worth the risk?
  6. Have you considered the possibility that the side effects you’re having are not just normal side effects from a GLP-1 type compounded drug and may be from an impure product?

Yikes.

Complications? What Complications? (just another GLP-1 receptor agonist post)

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Adverse events are common in those using GLP-1 agonists, but the vast majority of these are minor. GI adverse effects are most common (20-70% of patients). Greater rate of GI effects with higher doses.

  • Most common problems: nausea (overall most common), vomiting, and diarrhea. Others included abdominal pain, dyspepsia, and constipation.
  • Symptoms are typically more severe within the first four weeks of therapy or with sudden escalation of therapy and tend to decrease over time.
  • Thought to be due to reduced gastric emptying and activation of centers involved in appetite regulation and nausea.
  • Severe diarrhea and vomiting may lead to volume loss, dehydration, and hypotension (not common).
  • There is an association with pancreatitis. GLP-1 agonists may stimulate pancreatic islet beta cells and exocrine duct cells leading to overgrowth and smaller duct size, which increase the pancreatic weight and risk of ductal occlusion.
    • Retrospective study published in 2022 of 81,752 adverse events associated with GLP-1 agonist therapy found an increased risk of pancreatitis, particularly with liraglutide (ROR 32.67; 95% CI 29.44-36.25). 2023 observational study found increased risk of pancreatitis (adjusted HR of 9.09, 95% CI 1.25-66).
  • Other GI issues include gallbladder and biliary tract disease (usually after 26 weeks of therapy and included cholelithiasis, cholecystitis, cholangitis), elevated LFTs, hepatitis, liver injury.
emDOCs Podcast – Episode 94: GLP-1 Agonist Complications — https://www.emdocs.net/?s=glp-1

But I Lost 25 pounds!

New Wonder Drug! Treat Diabetes, Obesity AND Addiction – (yup another GLP-1 receptor agonist post)

Why People Stop Using Drugs Like Ozempic – Wired (yet another GLP-1 receptor agonist post)

What the Scientists Who Pioneered Weight-Loss Drugs Want You to Know – Wired Magazine

Cannabis and Arrhythmia Risk, Stroke and Race, Why Weight Loss Drugs Stop Working

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Within 180 days, 42 medical cannabis users and 107 control participants developed arrhythmia, most commonly atrial fibrillation/flutter. Medical cannabis users had a slightly elevated risk for new-onset arrhythmia compared with nonusers (180-day absolute risk, 0.8% vs 0.4%). The 180-day risk ratio with cannabis use was 2.07 (95% CI, 1.34-2.80), and the 1-year risk ratio was 1.36 (95% CI, 1.00-1.73). Adults with cancer or cardiometabolic disease had the highest risk for arrhythmia with cannabis use (180-day absolute risk difference, 1.1% and 0.8%).

Medical Cannabis for Chronic Pain Tied to Arrhythmia Risk – Medscape – January 12, 2024 — https://www.medscape.com/viewarticle/medical-cannabis-chronic-pain-tied-arrhythmia-risk

The overall incidence of stroke and ischemic stroke (IS) decreased among both White and Black people over the past two decades, results of an updated analysis of stroke trends in a representative US population showed.

However, the study showed persistent racial disparities, with incident stroke rates 50%-80% higher in Black people than in their White counterparts. Incident stroke also occurred at an earlier age in Black patients than in White patients (mean age, 62 years vs 71 years, respectively).

The findings were published online on January 10, 2024, in Neurology.

New Data on Stroke Incidence Rates by Race – Medscape – January 12, 2024 — https://www.medscape.com/viewarticle/new-data-stroke-incidence-rates-race

And my favorite Saturday morning medical update…

But studies also have shown that once people stop taking these drugs — either by choice, because of shortage, or lack of access — they regain most, if not all, the weight they lost. Arguably more frustrating is the fact that those who continue on the drug eventually reach a plateau, at which point, the body seemingly stubbornly refuses to lose more weight. Essentially, it stabilizes at its set point, said Fatima Cody Stanford, MD, MPH, MPA, MBA, an obesity medicine physician at Massachusetts General Hospital and associate professor at Harvard Medical School in Boston.

Every study of weight loss drugs done over the past 40 years or so shows a plateau, Stanford told Medscape Medical News. “If you look at the phentermine/topiramate studies, there’s a plateau. If you look at the bupropion/naltrexone studies, there’s a plateau. Or if we look at bariatric surgery, there’s a plateau. And it’s the same for the newer GLP-1 drugs.”

The reason? “It really depends on where the body gets to,” Stanford said. “The body knows what it needs to do to maintain itself, and the brain knows where it’s supposed to be. And when you lose weight and reach what you feel is a lower set point, the body resists.”When the body goes below its set point, the hunger hormone ghrelin, which is housed in the brain, gets reactivated and gradually starts to reemerge, she explained. GLP-1, which is housed in the distal portion of the small intestine and in the colon, also starts to reemerge over time.

Why Do GLP-1 Drugs Stop Working, and What to Do About It? – Medscape – January 12, 2024 — https://www.medscape.com/viewarticle/why-do-glp-1-drugs-stop-working-and-what-do-about-it

That’s it for this Saturday. Time to go to the Y and read a book later.