(Bloomberg) -- US health regulators warned that patients may be injecting themselves with incorrect amounts of copycat weight-loss drugs, causing harm that has landed some in the hospital.
Because of shortages of the brand-name medicines made by Novo Nordisk A/S and Eli Lilly & Co., the Food and Drug Administration allows compounding pharmacies to make copies of drugs like Wegovy and Zepbound. But while the approved versions are sold in the US as pens that automatically inject the medicine, the compounded drugs often come in vials. That requires patients to measure the amount they get with each injection themselves.
Some patients are giving themselves as much as 20 times the prescribed amount of compounded versions of Novo’s drugs, the FDA said on its website Friday. In a separate letter sent to health-care groups earlier this month, the agency said it has similar concerns about improper dosing of compounded versions of Lilly’s drugs.
Taking too much can cause severe nausea, vomiting, and low blood sugar levels, according to the FDA. Poison control centers have also been receiving calls about accidental overdoses of compounded weight-loss medicines.
Compounded drugs face less regulation than FDA-approved medicines, raising safety concerns. They can be prescribed by regular clinicians, and patients can also get them through telehealth outfits, like Hims & Hers Health Inc., as well as many private companies.
Shares of Hims fell as much as 8.1% Friday, after the FDA’s warning was published.
One difference is that compounded drugs don’t have standardized instructions approved by the government. Some patients might be told to inject a certain number of “units,” while others receive directions about milligrams or milliliters. Sometimes, clinicians prescribe the wrong dose, the FDA said.
Internet communities like Reddit abound with patients posting questions about how to convert between the different measurements.
(Updates fifth paragraph with more context, sixth paragraph with company share move.)
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