Pharmaceutical company Novo Nordisk is pursuing legal action against two compounding pharmacies for allegedly offering contaminated copycat versions of the drug semaglutide, found in weight-loss medications such as Ozempic and Wegovy.
The company said it had conducted tests on the compounded drug being sold from two Florida pharmacies and found one sample from Wells Pharmacy with impurity level of 33 percent and another from Brooksville Pharmaceuticals that had at least 19 percent less semaglutide than advertised.
Semaglutide is patented by Novo Nordisk. The company filed two lawsuits Wednesday night to warn patients that the compounded drugs are not approved by the Food and Drug Administration (FDA) and are “potentially unsafe and ineffective.”
In a release, the company said they have filed seven complaints against medical spas, medical clinics and weight loss clinics for false and misleading advertising. They have filed five legal actions against pharmacies that are engaging in the unlawful sale of the compounded drugs.
It has obtained preliminary injunctions against six businesses, preventing them from continuing to label products as such. It also requires the entities to label that it is not FDA approved in future marketing of the drug.
“Compounded products do not have the same safety, quality and effectiveness assurances as FDA-approved drugs, and adulterated and misbranded injectable compounded drugs may expose patients to significant health risks,” Jason Brett, Novo Nordisk’s executive director for medical affairs, said in a statement.
The high levels of impurities and low levels of strength could potentially put the patient’s health at risk, Brett’s statement said.
The company said the impurities were related to peptide, which has the potential to “stimulate an immunological reaction” and has the possibility to lead to serious and life-threatening reactions.
Inaccurate strength of the product puts patients at risk of taking drugs that are less effective than expected, the release said.
“FDA has warned that it has received an increasing number of adverse event reports and complaints after patients used compounded products claiming to contain semaglutide,” the company’s release said.
