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Drug makers can’t make knockoff weight-loss drugs anymore—and they’re mad

✇Science – Ars Technica
Beth Mole

Compounding pharmacies are suing the Food and Drug Administration so they can keep making imitation versions of popular—and lucrative—tirzepatide drugs, namely knockoffs of Mounjaro for diabetes and Zepbound for weight loss.

Generally, compounding pharmacies make customized formulations of drugs for patients with specific needs, like when a patient has an allergy to a filler ingredient or if a child needs a liquid version of a drug that normally comes as a capsule. But larger compounding operations are also legally allowed to make imitations of branded drugs if those drugs are in short supply, acting as a stopgap for patients.

Tirzepatide has certainly been in short supply in recent years. Given the high prevalence of diabetes and obesity in America and the drug's effectiveness, demand for tirzepatide and other drugs in the new GLP-1 class have skyrocketed, and many patients have struggled to fill prescriptions. The FDA placed tirzepatide on its drug shortage list in December of 2022—and that's where it remained until last week.

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© Getty | Sandy Huffaker

People are overdosing on off-brand weight-loss drugs, FDA warns

✇Science – Ars Technica
Beth Mole
Wegovy is an injectable prescription weight-loss medicine that has helped people with obesity.

Enlarge / Wegovy is an injectable prescription weight-loss medicine that has helped people with obesity. (credit: Getty | Michael Siluk)

The US Food and Drug Administration has approved two injectable versions of the blockbuster weight-loss and diabetes drug semaglutide (Wegovy and Ozempic). Both come in pre-filled pens with pre-set doses, clear instructions, and information about overdoses. But, given the drugs' daunting prices and supply shortages, many patients are turning to imitations—and those don't always come with the same safety guardrails.

In an alert Friday, the FDA warned that people are overdosing on off-brand injections of semaglutide, which are dispensed from compounding pharmacies in a variety of concentrations, labeled with various units of measurement, administered with improperly sized syringes, and prescribed with bad dosage math. The errors are leading some patients to take up to 20 times the amount of intended semaglutide, the FDA reports.

Though the agency doesn't offer a tally of overdose cases that have been reported, it suggests it has received multiple reports of people sickened by dosing errors, with some requiring hospitalizations. Semaglutide overdoses cause nausea, vomiting, abdominal pain, fainting, headache, migraine, dehydration, acute pancreatitis, and gallstones, the agency reports.

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