As demand skyrockets for GLP-1 drugs that can trigger significant weight loss, unauthorized versions of the treatments have started to fill pharmacies.

In late May, the FDA warned of illegal knockoffs of Novo Nordisk’s Ozempic and Wegovy. Now, five weeks later, the Danish company has filed its second wave of lawsuits against pharmacies in the U.S. that are producing the copycats.

Thursday, in federal courts in Florida and Tennessee, the company accused four companies of making compounded versions of its products that are not approved by the FDA.

“Testing new drugs and obtaining the regularly acquired regulatory approval to sell them are time-consuming and very costly,” Novo said in its complaints. “Ignoring drug-approval requirements provides defendant an unfair competitive advantage over pharmaceutical manufacturers like Novo Nordisk. Worse, it puts patients at risk by exposing them to drugs that have not been shown to be safe or effective.”

The defendants are compounding pharmacies that are authorized to produce drugs that are in shortage. But, according to Novo, the pharmacies are making the products with an unauthorized version of their active ingredient, semaglutide.

In its warning from May 31, the FDA said that there have been reports of adverse events from users of compounded versions of Ozempic and Wegovy. The agency also revealed that some compounded versions have been found to contain salt versions of the active ingredient—semaglutide sodium and semaglutide acetate.

The agency also suggested that users of online pharmacies screen them through its BeSafeRx campaign.

The suits were filed in Nashville, Tennessee, against DCA Pharmacy, in Tampa, Florida, versus Brooksville Rx, and in Jacksonville, Florida, against TruLife Pharmacy and WellHealth Rx.

None of the companies responded immediately to a request for comment.

In the suits, Novo pointed to a fungal infection outbreak in 2012 that was traced to a compounding pharmacy. According to scattered reporting, more than 100 users of the compounded product died, Novo said.

Last month, Novo filed similar suits against five health spas, clinics and pharmacies in Florida, New York, Tennessee and Texas.

In response to a request for more information, Novo cited a press release from when it filed the lawsuits last month.

Source: https://www.cnn.com/2023/06/20/health/novo-nordisk-lawsuits/index.html