This content originally appeared on On a regular basis Health. Republished with permission.

By Ross Wollen

Medically Reviewed by Sean Hashmi, MD, MS, FASN of American College of Lifestyle Medicine

Desperate for a reasonable source of the brand new generation of potent anti-obesity drugs, some people have turned to a potentially dangerous technique: mixing their very own semaglutide (Ozempic, Wegovy) or tirzepatide (Mounjaro) at home.

DIYers purchase the raw materials, energetic pharmaceutical ingredients of mysterious origin and unknown safety, online, with no prescription obligatory. While these materials carry warning labels — “for research only” or “not allowed to be used in humans” — that hasn’t stopped people like Carlos Alvarez, 58. He moderates an online forum dedicated to the seek for sources of tirzepatide, the energetic ingredient within the blockbuster drug Mounjaro. At his home in Phoenix, Arizona, Alvarez reconstitutes freeze-dried tirzepatide powder with sterile water, creating an answer that he injects under his skin.

Alvarez, who has prediabetes, felt frustrated that his insurer wouldn’t cover Mounjaro, the drug that he determined could be the very best treatment for his high blood sugar levels. The associated fee, he says, was “astronomical.” Wanting to avoid “the mercy of a medical system that I feel has left me without help … I went the complete DIY route. It’s in my nature anyway.”

But experts say what Alvarez and others are doing poses many risks.

“It’s not protected to make it in your kitchen. It’s just not protected in any respect,” says Stephanie Young Moss, PharmD. Dr. Young Moss is a trained pharmacist and healthcare consultant. While she acknowledged that “individuals are desperate” for the game-changing anti-obesity drugs, she expressed suspicion of any vendor who would sell drugs marked “for research only” on to consumers.

“Who’s behind this website? Where are they getting this drug? Is it the best form? Is it clean, is it sterile?”

The U.S. Food and Drug Administration (FDA) warns consumers in regards to the practice as well.

In a press release, the FDA said that “peptides marketed as ‘sold for research use’ … pose significant risks to patients because they’ve not been reviewed by the FDA before they’re marketed to make sure safety, effectiveness or quality, they usually are obtained with no prescription or prescriber oversight.”

Scott Brunner, the CEO of the Alliance for Pharmacy Compounding, says that reconstituting such drugs at house is a dangerous idea. “The apparent advice for anyone purchasing research-grade semaglutide (or something purporting to be semaglutide — how do they know?) online with no prescription, and self-administering, is: don’t.”

How Do People Make Their Own ‘Ozempic’?

Propelled by immense social media hype, the demand for semaglutide and tirzepatide has skyrocketed, leading to shortages despite very high prices. On the time this text was written, a Mounjaro prescription was listed at over $1,000 monthly at most pharmacies, and insurance coverage for the drug could be hard to seek out, especially for those without diabetes. The high cost and inconsistent access have already driven some users to obtain their medication from quite a lot of sources, including online compounding pharmacies, which may legally mix off-brand versions of the favored medications. In late May, the U.S. FDA warned consumers against compounded semaglutide, which the organization doesn’t evaluate for safety or effectiveness.

DIYers are going a step further and are taking the practice of drug compounding into their very own hands.

The DIY process starts with lyophilized (freeze-dried) semaglutide or tirzepatide, a powdered type of the energetic pharmaceutical ingredient (API) utilized in Ozempic or Mounjaro. Using insulin syringes and sterile glass vials, do-it-yourself ‘pharmacists’ mix the powdered energetic ingredient with bacteriostatic water, which has been formulated to stop the expansion of bacteria. Reconstituting the drug in this way creates a liquid solution, purportedly the equivalent of the brand-name drug, which may then be injected under the skin. Instructions for these homemade injections could be found on TikTok, YouTube, and elsewhere on the web.

Because the practice has grown, recent online communities have sprung up by which users share their experiences finding these powdered drug ingredients, that are often known as “peptides.” Some community members fear that suppliers are providing peptides of dubious safety or potency, or running outright scams. Others worry that a trusted source will grow to be too popular, resulting in shortages or legal troubles. Essentially the most reliable peptide vendors, some assert, don’t even have web sites, just email addresses which are passed from one user to a different.

It’s difficult to gauge the dimensions of DIY reconstituting, but Facebook groups and subreddits largely dedicated to using semaglutide and tirzepatide peptides can count lots of of members, and far discussion could be present in larger forums more generally dedicated to using peptides or of compounded weight reduction drugs.

Alvarez, who moderates one such forum, also creates YouTube videos to show the reconstitution procedure. Alvarez has no pharmacological training — he’s just an enthusiastic amateur: “You may say that I’ve jumped into this topic like a skydiver with no parachute.”

Alvarez has used several different sources for his powdered tirzepatide, including a Chinese vendor that offered a low price for a bigger shipment. He reports that tirzepatide — he has alternated between official Mounjaro and self-mixed versions — has brought him “exceptional, life-changing, massive results,” including rapid weight reduction, improved blood sugar levels, higher sleep, and fewer desire for alcohol.

Semaglutide and tirzepatide, originally developed to treat hyperglycemia in type 2 diabetes, have widely been hailed as probably the most effective weight reduction drugs ever approved. In a single clinical trial of semaglutide, adults without diabetes lost a mean of 14.9 percent of their body weight. In one other, tirzepatide users without diabetes lost much more, a mean of 20.9 percent of their body weight at the very best dose.

Though he acknowledges that there are risks inherent with injecting drugs from suspect sources, Alvarez argues that the choice — stopping his use of anti-obesity medication, regaining weight, and watching his blood sugar climb back up — is the greater danger. “I consider that it’s reasonable to conclude that [my prediabetes] was much worse than the potential risk.”

‘Incredibly Dangerous’

There are, in fact, many the explanation why drug preparation and distribution are reserved for trained and licensed professionals. Offering an example of the hazards of contaminated drugs, Young Moss referred to a 2018 incident by which a single compounding pharmacist ignored standard safety procedures and infected 793 patients with fungal meningitis; 64 died.

Among the infrastructure for the grey market sale of peptides was erected long before #ozempic went viral, largely for the distribution of a special form of pharmaceutical product: growth hormone peptides and other performance-enhancing drugs. Bodybuilders and athletes have been mixing and dosing their very own solutions in the identical manner, with insulin syringes and bacteriostatic water, for years. Others use peptides for skincare or sexual health, amongst other issues.

While the FDA declined to debate the legality of the sale or use of weight reduction peptides, prior to now the organization has pursued legal motion against suppliers. In 2016, for instance, the owner of Precision Peptides was sentenced to accommodate arrest and ordered to forfeit over $2 million for selling unapproved peptides to bodybuilders. A press release from the U.S. Attorney’s Office described how in “a ruse to avoid FDA scrutiny,” the peptides had been labeled “for research/laboratory use only.”

Brunner states that using such peptides, which come from unknown and possibly unregulated manufacturers, is dangerous: “For a patient to trust and inject that substance into their body is incredibly dangerous.”

Even when the energetic ingredient is protected, DIYers open themselves as much as other risks when reconstituting their medicine. The manufacturers of Ozempic and Mounjaro have created standards to make dosing as streamlined and straightforward as possible: one injection, once per week, with a pen designed to manage only a single dose. The mathematics involved with reconstituting peptides is considerably more complicated, requiring facility with conversions between milligrams, milliliters, and insulin units. The danger of dosage error could also be astronomically higher.

During his temporary time championing DIY Ozempic and Mounjaro, Alvarez has seen some heinous and potentially very dangerous blunders on social media, including elementary math errors which have led users to self-administer gargantuan quantities of medication. “I saw loads of mistakes being made by loads of people,” he says. He hopes that his comments and videos will help others use the drugs safely.

Though his behavior could appear reckless, Alvarez shares a priority with many experts that the inaccessibility of semaglutide and tirzepatide is barely exacerbating healthcare disparities. These medications can have revolutionary health effects — “life-changing is an understatement,” contends Alvarez — but their high costs, combined with the reluctance of insurers to cover those costs, threatens to order the therapies for affluent Americans.

“I consider that these alternatives provide a free-market solution to the issue,” Alvarez states. “I believe that consumer anarchy might force change in how we price these drugs.”

Staying Protected

It could appear easy for conscientious patients to avoid DIY weight reduction drugs, however the lines between reputable and disreputable suppliers are getting blurred. Voracious demand for (and shortages of) Ozempic, Mounjaro, and Wegovy are inspiring more clinics and telehealth providers to supply the load loss medicines, and it may be difficult to know which providers have their patients’ best interests at heart.

In a press release to On a regular basis Health, Novo Nordisk said that it “doesn’t supply semaglutide to corporations selling research-use only products to patients,” a practice which it says “exposes patients to potentially unsafe products.”

The National Association of Boards of Pharmacy (NABP) publishes a “Not Beneficial” list of 1000’s of internet sites which are suspected of selling “fraudulent and unsafe” medicine. The NABP verifies that pharmacies are fully licensed, comply with all relevant laws, and accept only valid prescriptions. Within the event that there may be any ambiguity a few supplier’s trustworthiness, it is likely to be clever to ascertain any online medicine supplier against the list, though it shouldn’t be considered exhaustive.

In a statement, Brunner and his organization advised the next:

“Don’t buy any substance presupposed to be semaglutide from a web based entity should you wouldn’t have a legitimate prescription for it from a licensed prescriber, and you can not confirm that the vendor is a licensed U.S. pharmacy.”