FDA Says Mounjaro, Zepbound Shortage Has Ended: What to Know

• Zepbound and Mounjaro have been on the Food and Drug Administration’s shortage list for months.
• Many people who rely on them to treat diabetes or help with weight loss have had trouble filling their prescriptions as a result.
• In response, manufacturer Eli Lilly has ramped up production, and now, according to the FDA, they are available again.

Weight loss and diabetes GLP-1 drugs like Mounjaro, Zepbound, Wegovy , and Ozempic have flown off the shelves in recent years, outstripping manufacturing and leading to shortages. This has made it challenging for some people to get access to the drugs they need.

In fact, the diabetes medication Mounjaro has been on the Food and Drug Administration’s shortage list since late 2022, while Zepbound , a drug approved for weight loss, appeared on the list in April 2024.

To meet this growing demand, drugmaker Eli Lilly has bolstered their manufacturing to increase supply and make the drugs readily available again .

On August 1, Lilly CEO David Ricks said in an interview with Bloomberg that the shortage would end “very soon,” Reuters reported .

The next day, the Food and Drug Administration updated the status of Mounjaro and Zepbound in its drug shortage database to indicate they are available once more.

Shortages increased demand for compounded versions of GLP-1 drugs

In 2023, Mounjaro drove more than $5 billion in sales, and in the first four months of 2024, doctors issued 63,000 Zepbound prescriptions weekly .

As supplies of these medications dwindled, some pharmacies began producing compounded versions to fill the gaps.

The FDA Food, Drug, and Cosmetic Act allows pharmacists to produce and sell compounded versions, making them a lifeline for those who need the medication. Due to the drug shortage, compounded versions of GLP-1 drugs have become a billion-dollar enterprise .

Britta Reierson, MD , a board certified family physician and obesity medicine specialist, explained that compounded drugs are “custom-made medications prepared by pharmacists to meet the specific needs of a patient.”

“Compounded versions of drugs are not regulated nor approved by the FDA,” Reierson told Healthline.

Mir Ali, MD , a board certified bariatric surgeon and medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, CA, added that “as long as the source is reputable, this is a viable alternative.”

Still, consumers ought to perform their due diligence when considering compounded GLP-1 drugs.

A news release from Eli Lilly in June 2024 outlines some concerns surrounding compounded versions of tirzepatide (the active ingredient in Mounjaro and Zepbound), some of which contained bacteria: “Sterility is a critical safety concern, given that Mounjaro and Zepbound are administered via under-the-skin injection.”

They also write in the release that “in at least one instance, the product was nothing more than sugar alcohol.”

How shortages of GLP-1 drugs impacted people with diabetes

“The national shortage of Zepbound and Mounjaro undoubtedly impacts many people’s health and wellness,” HaVy Ngo-Hamilton, PharmD , a pharmacist and clinical consultant at BuzzRx, told Healthline.

“For a diabetic patient who takes Mounjaro for their blood sugar, not being able to obtain this medication can be detrimental, leading to kidney disease, nervous system issues, and vision problems,” she added.

Ngo-Hamilton explained the issue becomes exacerbated for people who take Mounjaro, as this drug is more frequently used by individuals who cannot tolerate metformin (the most common drug to treat type 2 diabetes ) or who do not benefit sufficiently from it.

“Additionally, the uncertainty and stress of not being able to access essential medications has negatively affected their overall well-being and quality of life,” Reierson explained. “The shortage in medications has led to clinicians recommending different medications that may be easier to access, yet may not be as effective for an individual patient.”

Why GLP-1 drug shortages will likely continue

Despite the fact that Mounjaro and Zepbound are no longer in short supply, we may not have seen the end of these shortages.

“I think the shortages are likely to continue for the foreseeable future,” Ali told Healthline. “As long as obesity continues to be a big concern, the demand for these medications will remain high.”

Reierson agreed, explaining that “factors like increased demand, supply chain disruptions, and manufacturing challenges” are likely to continue causing supply challenges.

Ngo-Hamilton said she believes “we are better prepared to prevent shortages now that manufacturers have a clearer understanding of the product demand.”

She also noted that FDA-approved alternatives are now entering the market, easing the pressure on Eli Lilly.

Are too many people taking GLP-1 drugs like Zepbound and Mounjaro?

These medications have been a game-changer in treating obesity, as they can help people lose significant weight.

However, they are not a magic bullet, and many are worried that their popularity may be causing several issues.

“I have concerns about what I see as widespread and uninformed use of these medications,” Reireson said. “There continue to be mixed messages through social media and endorsements by celebrities that may lead people to seek these medications ‘off-label,’ even if not clinically indicated.”

“The soaring demand has led to shortages and manufacturing delays, resulting in a surge in compounded, counterfeit, and fake medications to hit the market,” Reireson continued. “This keeps me up at night, knowing that some people are at risk for serious complications.”

Ngo-Hamilton had similar thoughts: “My primary concern about the widespread use of these medications is the potential implications for patient safety.”

“With increased marketing, influencer campaigns, patient testimonials, and wall-to-wall media coverage of celebrities experiencing weight loss success using these medications, it can be easy to overlook the potential risks and side effects.”

The takeaway

After months on the FDA’s shortage list, Eli Lilly’s GLP-1 drugs Zepbound and Mounjaro are once more available.

This is good news, as many people who rely on these medications to treat diabetes or help with weight loss have had difficulty filling their prescriptions.

However, while the drugs are currently available, health experts say the growing demand for them could mean more shortages in the future.