Unsafe Ozempic knock-offs flood the market
Weightloss Versions Producing Brand Of Demand After To Supply Pharmacies Of Copycats Drugs Taken Have In Pounding Name Us The The Outstripped
The first dose of a copycat weight-loss drug Lindsay Posey took from a new pharmacy worked well. The second didn’t quite suppress her appetite. It was the third dose that she thinks caused her trouble.
Acne erupted on her cheeks, nose, chin and forehead. “My skin just went absolutely crazy,” said the 38-year-old who works in online customer service. Acne isn’t listed as a side effect of the FDA-approved formulation.
Ms Posey had resorted to buying the knock-off medicine through a telehealth company because she didn’t think her insurance would cover the brand-name version. She trusted the situation because the drugs were made at a licensed facility in the US. “It just seemed safe,” she said.
Her doctor suggested it might have been a problem with the medicine itself. “That’s not really something you want to hear,” Ms Posey said.
The drugs were produced without going through the rigorous approval process required for brand-name or generic medications. They are made by so-called compounding pharmacies, an obscure corner of America’s pharmaceutical market that relies on a legal loophole to produce copies of treatments in short supply.
Doctors worry this shadow industry may be putting patients at risk. Normally focused on producing bespoke therapies, these pharmacies started making copies of weight-loss drugs en masse after demand outstripped the supply of Eli Lilly & Co.'s and Novo Nordisk’s medications.
Health insurers aren’t racing to cover the roughly $1,000-a-month brand-name drugs, leading people to seek cheaper alternatives.
It’s rare for lucrative drugs to so quickly go into short supply and stay that way for this long, said Carson Riley, a vice president at Bourne Partners who specialises in compounding. He called the recent explosion of copycat weight-loss drugs “unprecedented.”
Compounded medications are generally not paid for by insurance, putting them out of view of systems that normally track prescriptions. The US Food and Drug Administration (FDA) doesn’t monitor how many prescriptions are filled for compounded drugs.
In that blind spot, experts estimate hundreds of thousands of Americans are taking medicine that hasn’t been vetted by the FDA for safety and effectiveness the way a typical prescription drug would be.
Last year, a patient injected a copycat version of Lilly’s Mounjaro made by Galleria Medical Pharmacy which allegedly caused burning and inflammation, according to state records.
A Louisiana Board of Pharmacy investigation found the drug was not tested for sterility or endotoxins, which are fragments of bacteria. At least 297 prescriptions were made from five different lots of weight-loss drugs that hadn’t been tested properly.
Galleria said the problem that caused the person’s symptoms was due to a malfunctioning pH metre rather than toxins or a lack of sterility. “There was no finding that the lack of specified testing was associated with any adverse event,” the pharmacy said. Galleria has since been fined, replaced the faulty pH metre and added new training and compliance measures.
Just last month in Arizona, DeeFlat Pharmacy’s licence was voluntarily suspended after the pharmacy board found that compounded weight-loss drugs were being made improperly. The pharmacy appeared to be compounding the drugs “under non-sterile conditions”, according to state records.