Archives for November 2024

I’ll avoid using the picture of the Mounjaro injector to see whether that is what is triggering the draconian Facebook anti-spam algorithm. But who knows? They might delete my link to this post anyway. So, if you don’t see this on Facebook this week, I hope you’ve subscribed via the provided tool on the right. You won’t get any spam from me, just my bullshit. The creepy AI-generated cat picture I have included is meaningless, but Facebook appreciates cats, as is affirmed by the ubiquitous cat images on the social media platform. So, how could they possibly object?

For those who are new to this weekly Mounjaro update, in it I report my progress on the type two diabetes drug, on which I initiated therapy last June. Additionally, I cover topics I presume to be of interest to anyone either using or considering using this medication for diabetes. I add editorial comments about controversial topics from time to time. Hey, it’s my blog, and it’s the only soap box I have! And, by the way, a trip around the world is not a cruise, and medical treatment is not a journey.

This week on my non-journey, I’ll be looking into reports of tainted compounded versions of semaglutide and tirzepatide, the generic equivalents of Ozempic/Wegovy and Mounjaro/Zepbound, plus Novo Nordisk’s warnings about such drugs. Then, I’ll report on my health progress, always fertile territory for commentary, given that I am a metabolic horror story who has outlived his life expectancy.

Compounded Semaglutide Perils?

The drug that caused the off-label, fat loss craze that started it all, Ozempic, has inspired a profitable secondary market. Compounding pharmacies sell compounded versions of its active ingredient, semaglutide, to the weight-loss crowd. Although Novo-Nordisk, the Danish manufacturer of the branded drug has also sought and received FDA approval for sister drug Wegovy (also semaglutide) specifically for weight loss, these branded drugs are costly. When drugs are in short supply, the FDA allows compounded, generic versions to be sold. Thus, current supply shortages of semaglutide and tirzepatide (Mounjaro/Zepbound) have enabled opportunistic compounding pharmacies to produce and sell lots of generic, compounded product.

But compounding pharmacies are state regulated. Although required to report regularly to the FDA, they can take shortcuts in reporting data. State inspections vary in thoroughness and effectiveness. Unsanitary facilities sometimes are not detected. But the average consumer lacks the expertise and availability of data to vet these outfits. Does anyone know where the ingredients come from, how the drugs are produced and under what conditions, and so forth? Much of the weight-loss public’s hunger for these vogue drugs relies on faith.

Even if most facilities are sterile and take great care to avoid selling contaminated products, occasionally, a horrible tragedy occurs. Such was the New England Compounding Center case, in which dozens of people died and 750 suffered grievous bodily harm. How does one know what one is injecting into their body? Although most compounded medications are safe, it takes only one bad batch to wreak havoc. That there is even one such batch of tainted medication out there makes it akin to playing Russian Roulette.

Deaths and Hospitalizations

Approximately 10 deaths and 100 hospitalizations in the United States have been linked to use of off-brand, compounded semaglutide, according to the drug’s manufacturer Novo Nordisk. Similar issues have been reported from use of compounded tirzepatide, the active component in Eli Lilly & Company’s Mounjaro and Zepbound. Both Novo Nordisk and Eli Lilly have taken steps to curtail the distribution of compounded versions.

Naturally, the compounding pharmacy industry and their partners in retail weight-loss clinics and health spas are outraged. So are members of the weight-loss community who are addicted to these drugs and who can’t afford the high-priced branded products. One cannot blame Novo Nordisk and Eli Lilly for wanting to protect their profits. But the boosters of the compounding industry have characterized their efforts to inform and warn consumers as transparent attempts to control the market. I am not going to land on either extreme. I merely preach using caution when buying compounded products. Be as thorough as possible in researching the company that will sell you something you inject into your body.

Fullerton Wellness product contamination

As of November 1, the FDA warned patients and health care professionals not to use drugs compounded and distributed by Fullerton Wellness LLC, Ontario, Calif., dispensed to patients by medical offices and clinics. On August 14, 2024, FDA received a complaint from a patient who noticed a black particulate in a vial of semaglutide distributed by Fullerton Wellness. On September 23, 2024, FDA received information from California regulatory authorities as part of ongoing collaboration between FDA and the state noting deficiencies found at Fullerton Wellness during a state inspection. After the state inspection, Fullerton Wellness voluntarily ceased operations.

However, the tainted drugs were distributed and are still lurking out there. This certainly is an example that underscores the need to proceed cautiously.

FDA Guidelines for Consumers

Although I frequently question the FDA’s ties to Big Pharma, likening the agency to the fox guarding the henhouse, it still performs some valuable services. The FDA’s recommendations for use of compounded versions of GLP-1 drugs, including tirzepatide and semaglutide, are worthwhile reading for anyone seeking to improve their chances of avoiding adverse events when considering alternative sources. The agency has identified several areas of concern for compounded GLP-1 drugs. It is working with its state regulatory partners and will continue to communicate with compounders regarding these concerns. 

The agency states that as of August 31, 2024, FDA has received: 

• 136 reports of adverse events with compounded tirzepatide. 
• 346 reports of adverse events with compounded semaglutide.

Considering the burgeoning size of the market and the number of units sold, the number of adverse events is small. But if you care about what you inject into your system, this document is well worth your time. Consider it that ounce of prevention. Saving a few bucks now using questionable drugs from loosely regulated suppliers can cost you dearly in the future. Be careful!

My Progress on Mounjaro

My doctor prescribed Mounjaro at the starting 2.5 mg dose back in early June 2024. After ten weeks, my dose moved up to 5 mg, which I have injected weekly since then. Although not cheap, I am fortunate to have insurance coverage through my Part D Medicare prescription drug plan. Otherwise, I would either need to pay the retail price (about $1100/mo) or deal with tele-health compounding pharmacies. As you know, I am wary about the latter, so I would avoid that alternative.

My aim is to get my numbers in line, then “kick the habit.” I do not wish to be shooting up with Mounjaro forever. Meanwhile, I am relearning how to control carbs, with feedback from my continuous glucose monitor. (Yes, more money out the window, but diabetes ain’t cheap). The monitor enables me to gauge the effect of various foods on my blood sugar. For example, a recent lunch at our favorite Greek joint yielded an unexpected spike. I thought stuffed grape leaves would be fine, but the rice in them (plus God knows what in the lemon sauce) was too much of a glycemic load. So, as my old friend Joey’s mom used to say, “Learn to eat!” Once I do and I commit myself to good habits, I hope to wean myself from Mounjaro.

The Mounjaro Numbers, Already!

Average glucose for the week has been about 100 mg/dL (5.6 mmol/L), roughly flat. Morning fasting glucose averaged 101 (5.6), still above where I want it to be. No more dolmades for me!

Weight fluctuation was minimal during the week, winding up at 199.6 lbs (90.7 kg). Aside from the grape leaves, I can’t think of any serious dietary transgressions, so I’ll consider this a weight plateau. As you recall, weight loss is a secondary or tertiary goal of mine, so I’m not going to get all upset over not consistently “looseing weight” (sic – common egregious social media misspelling).

My physical therapy for lumbar radiculopathy continues apace. Although I have not felt much of a difference in pain levels, the core strengthening exercises and stretching are doing me good. The nagging pain, burning, and numbness from the related meralgia paraesthetica continues. Its onset was just before I started the PT. It is an inflammation of the femoral lateral cutaneous nerve, a sensory nerve associated with the lateral aspect of the thigh. Nerves take time to heal, but I decided not to leave it to chance, lest there be some correctable impingement going on there. To gain a better perspective, I made an appointment with a physiatrist (physical medicine and rehab doc) in early December. I hope more physical therapy will help with the problem, so I am not making any appointments with neurosurgeons — yet.

That’s It for Now

Summing it all up, I hope I have added enough useful information to my mundane health issues to have made this read worthwhile for you. I will return next week with another update — and maybe, a new cat picture.