In response to a lawsuit, the FDA has said that it will reevaluate its previous decision to remove tirzepatide from its shortage list

Using a Compounded Weight Loss Drug? What the End of a Tirzepatide Shortage Could Mean For You Here's what taking the drug of the list could mean for people taking tirzepatide or its compounded versions

In response to a lawsuit, the FDA has said that it will reevaluate its previous decision to remove tirzepatide from its shortage list

• In response to a lawsuit, the FDA said it would reconsider its previous decision to remove tirzepatide, the active compound in the weight loss and diabetes drugs Mounjaro and Zepbound, from its shortage list.
• Removal from the list would mean that pharmacies can no longer offer compounded versions of tirzepatide for the purpose of meeting demand due to the shortage.
• If the FDA were to eventually remove the drug from the shortage list, this would have significant implications for people using tirzepatide or compounded versions of the drugs.

Is tirzepatide, the active ingredient in the diabetes and weight loss drugs Mounjaro and Zepbound, in short supply? That’s the question at the center of a new lawsuit that could have significant implications for people who use—or want to use—the popular drug or its compounded version.

The legal saga started on October 2, when the FDA announced that it had removed tirzepatide from its shortage list—where it’s been since 2022 due to surging demand. The agency said it confirmed with drug manufacturer Eli Lilly that its “stated product availability and manufacturing capacity can meet the present and projected national demand.”

The announcement caused an uproar among compounded pharmacists and patients due to one big side effect: Removing tirzepatide from the shortage list would prevent pharmacies from producing compounded versions of tirzepatide for many people who want them. Under U.S. law, pharmacies can legally produce compounded versions of brand-name drugs that are “essentially a copy” of brand-name drugs, but only if they’re in shortage. Despite dosage errors and other issues related to compounded weight loss drugs, which are not FDA-approved, many people have come to rely on them due to their relative affordability and availability.

Unsurprisingly, about a week later, the compounding industry group Outsourcing Facilities Association sued the FDA, saying it made a “reckless and arbitrary decision” when it “abruptly” moved tirzepatide from the shortage list.

In response, the FDA has now reversed course. It said in a court filing on Friday that it would once again allow pharmacies to sell compounded versions of tirzepatide while it reconsiders its decision to remove the medications from the shortage list.

While for now, nothing has changed for people who use tirzepatide or its compounded versions, experts say that if the FDA does eventually remove the drug from the shortage list, it could pose both major benefits and challenges for countless people interested in this drug. Here’s how.

Easier Access For Some

Mounjaro is FDA-approved for managing type 2 diabetes, while Zepbound has been approved for weight loss in adults with a body mass index over 30 or for those with a BMI of 27 and at least one weight-related condition, such as high blood pressure or high cholesterol.

If the FDA removes tirzepatide from the shortage list, experts said that it should—in theory—be more accessible for people who want to take the drugs and for people who already have a prescription. 

“The end of the shortage would suggest that there is adequate supply of all dosages of Mounjaro and Zepbound for patients who are taking these FDA-approved medications,” Allison Rhodes, MD, an assistant professor of clinical medicine in the division of general internal medicine at The Ohio State University Wexner Medical Center, told Health. “This should ensure that patients do not have to worry about not being able to fill their prescription at the pharmacy to stay on track with weekly dosing or dose escalations.”

W. Scott Butsch, MD, MSc, director of obesity medicine in the Bariatric and Metabolic Institute at Cleveland Clinic, agreed that a resolution of the shortage should be welcome news for people taking Mounjaro and Zepbound, who may have had to miss doses in the past. “They will not have the challenges of long periods of time off the drug or intermittent use of the medication at lower doses forced by supply shortages,” he told Health.

Others ‘Forced’ Down a New Path

However, the end of the shortage may present challenges for people who’ve been taking compounded versions of the medication. 

Pharmacies can produce and sell compounded medications when a product is not commercially available—for instance, during a national shortage. However, if the FDA announces that the shortage is over, pharmacies shouldn’t be producing and distributing compounded tirzepatide in the name of meeting demand (though they can do it for other specific circumstances, such as if someone is allergic to an ingredient in a brand-name drug).

“The end of the shortage will likely impact individuals who have been prescribed compounded tirzepatide in a more significant way, as these individuals are forced to choose a different treatment pathway,” Rhodes said.

While it’s unclear how many people this would affect, some have estimated that millions of people could be using compounded versions of weight management drugs, including semaglutide, the active ingredient in Ozempic and Wegovy. 

If the shortage ends, experts said some people may stop taking the medication due to concerns over cost—many insurance plans don’t cover the cost of Mounjaro or Zepbound, forcing those who opt to take the prescription medications to pay out-of-pocket. 

Others may switch to FDA-approved tirzepatide. One option may be a lower-cost version of Zepbound released earlier this year. However, experts cautioned that the dosages may not work for all weight loss patients.

A third group may opt for compounded semaglutide, which is still on the shortage list. “Because semaglutide is the most mechanistically similar drug to tirzepatide, I envision for a while more Americans will utilize compounded semaglutide,” Rhodes said.

What’s for sure is that people shouldn’t turn to cheap versions of the drug promoted on social media platforms like TikTok, Sharon Giese, MD, a plastic surgeon and weight loss specialist based in New York, told Health. Often, these products aren’t produced in the U.S. and are not, in fact, tirzepatide, she added. “If the price is too good to be true, there might be a problem or a catch,” Giese said.

“Individuals who were taking compounded tirzepatide should work closely with their prescribing provider to identify the best alternative treatment based on their medical history, weight loss goals, and financial considerations,” Rhodes said.

This story originally appeared on: Health News - Author:Maggie O'Neill