The manufacturer of popular drugs Wegovy and Ozempic warned on Oct. 12 that it has seen a surge of counterfeit versions of its products in recent days.
Novo Nordisk “has seen a significant increase in illegal online sales,” according to a statement, referring to drugs that contain the active ingredient semaglutide.
“Every counterfeit case we are made aware of is looked into and reported to the authorities according to the applicable regulations,” the statement reads.
The Denmark-based pharmaceutical firm stated that in several cases of counterfeit drugs, it was working with “specialized firms to identify the perpetrators of these crimes.” It didn’t provide details on the countries where it was working with local officials.
It also stated that it was working with a third party specialized in monitoring and taking down illegal online offers. The firm scaled up this work in 2023 “to ensure an even broader reach,” it noted without naming the company it was working with.
The statement from Novo, earlier reported by Danish publication Finans, included the first detailed comments from the group on the counterfeit issue since a statement in mid-June about fake Ozempic pens found at a retail pharmacy in the United States.
In a further sign of illicit activity taking advantage of the hype around weight-loss drugs, the U.S. Food and Drug Administration (FDA) on Oct. 10 told two online vendors to stop selling unapproved versions of Novo and Eli Lilly drugs.
“As discussed below, [the] FDA has observed that www.semaspace.com introduces into interstate commerce unapproved and misbranded semaglutide drug products. There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs,” one of the letters reads. “Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight.”
In its letter to Gorilla Healing, the FDA stated that it had recently reviewed the company’s website and observed that it also introduces into interstate commerce misbranded and unapproved new drugs in violation of federal law.
The FDA stated that it’s demanding that the two firms “cease offering any unapproved and misbranded drugs for sale to U.S. consumers,” claiming that the move is “critical to protect the public from harm.”
The two firms have until the end of October to provide an explanation. But if they can’t, the FDA can take legal action against them, including seizure or an injunction.
FDA Warnings
In late September, the FDA announced that the drugs can lead to a potentially life-threatening condition known as “ileus,” characterized by impaired intestinal function.The FDA stated that some adverse reactions, including ileus, have been reported during post-approval use of semaglutide.
Ozempic works by mimicking the hormone GLP-1, which can slow down the passage of food in the large and small intestines as well as the stomach, making people feel full for longer. However, there have been reports that the drug can slow the intestines too much, leading to ileus and causing intestinal blockage.
Earlier this year, the FDA warned consumers to not use off-brand versions of Ozempic, Rybelsus, and Wegovy because they may not have the same ingredients.
“Drug compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient,” the agency stated in June. “Compounding includes the combining of two or more drugs. Compounded drugs are not FDA-approved, and the agency does not verify the safety or effectiveness of compounded drugs.”
Compounded semaglutide can contain a version of the ingredient that isn’t approved for human use, according to the FDA. It also warned that reports have indicated that some versions of compounded semaglutide contain salt, which changes the drug.
“The agency is not aware of any basis for compounding using the salt forms that would meet the [Federal Food Drug and Cosmetic Act] requirements for types of active ingredients that can be compounded,” the FDA stated.
