Public health group warns about fake weight loss drugs

INDIANAPOLIS, Ind. — As weight loss drugs continue to grow in popularity in the U.S., some health leaders are warning about fake drugs on the market.

Drugs like Zepbound, Ozempic, Mounjaro and Wegovy are approved by the FDA. This means they considered safe for individuals to take if a doctor has prescribed them. However, knockoff versions are starting to make their way around.

“We’ve never seen the level of criminality and carelessness that we’ve seen around the counterfeiting and compounding of medications on the weight loss space,” said Shabbir Imber Safdar, the executive director of The Partnership for Safe Medicines.

The Partnership for Safe Medicines is a public health group that recently released a report about these fake drugs.

It found availability of compounded versions of GLP-1’s have exploded in the U.S. despite warnings from the FDA.

The report found 199 shipments of semaglutides from manufacturers were not registered with the FDA. Out of the total, 159 shipments were allowed into the U.S. The report also found 40 shipments of tirzepatides, where 36 were allowed into the U.S.

The report found these fake drugs often come from foreign countries and are often much cheaper than the name brands.

“They’ve been coming into the country over the last 18 months from facilities that are unknown to the FDA, which means that there’s been no inspection, and people are injecting these into their bloodstream, often through compounded medications,” said Safdar. “We’re very concerned about what that means for patient safety.”

A recent public opinion poll the group conducted also found that most Americans don’t understand what it means for a medicine not to carry FDA approval.

FDA approval means that the agency has inspected and tested the drug for safety, effectiveness and manufacturing quality.

Safdar explained one of the biggest risks for people who take these counterfeit drugs.

“Mis-dosing is a really big one,” he said. “The labeling on these versus the labeling on branded products is entirely different, and so people have been accidentally overdosing themselves with compounded versions, which is a big concern for us.”

According to its report, the organization recommends the FDA refuse entry of any drug that “appear” to be misbranded or otherwise unapproved. The report also said that the manufacturers should be added to its “import watch list” and that the FDA and state boards of pharmacy should prioritize inspections of compounders that attempt to import GLP-1 active pharmaceutical ingredients from unregistered facilities.

“It’s never cheaper in the short run to endanger your life or the medicine you got that is not FDA approved,” said Safdar. “If you want to find the most economical option in the long run, it’s to get the FDA-approved product under your physician’s supervision.”

Indianapolis-based Eli Lilly creates the FDA approved tirzepatide products Zepbound and Mounjaro.

The company announced in February that it is adding additional Zepbound vial options and is taking steps to make those more affordable.

According to a release posted on its website, a 2.5 mg dose will be $349 per month and a 5 mg dose will be $499 per month.

It is also launching the Zepbound Self Pay Journey Program. It said this will reduce the price of the 7.5 mg ($599) and 10 mg ($699) doses to $499 per month at first fill and refills that occur within 45 days of prior delivery.