The manufacturer of popular drugs Wegovy and Ozempic issued a warning on October 12th, alerting the public to a recent surge in counterfeit versions of their products. Novo Nordisk, the pharmaceutical company behind these drugs, stated that there has been a significant increase in illegal online sales of medications containing the active ingredient semaglutide.
The statement emphasized that every case of counterfeit drugs is thoroughly investigated and reported to the authorities. Novo Nordisk is working with specialized firms to identify the culprits behind these crimes, although specific details about the countries involved were not disclosed.
The Denmark-based pharmaceutical firm revealed that it is collaborating with specialized third-party organizations to monitor and remove illegal online offers. In 2023, they have expanded these efforts to ensure a wider reach, although the specific company they are working with was not disclosed.
This statement from Novo Nordisk, initially reported by Danish publication Finans, provides the first detailed comments from the company regarding the issue of counterfeit drugs since their mid-June statement about fake Ozempic pens discovered at a retail pharmacy in the United States.
In another indication of illicit activity taking advantage of the popularity of weight-loss drugs, the U.S. Food and Drug Administration (FDA) recently ordered two online vendors to cease selling unapproved versions of Novo Nordisk and Eli Lilly drugs.
The FDA issued warning letters to two companies, Semaspace and Gorilla Healing, instructing them to stop selling online versions of semaglutide and tirzepatide.
One of the warning letters stated, “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. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight.”
In this photo illustration, boxes of the diabetes drug Ozempic rest on a pharmacy counter in Los Angeles on April 17, 2023. (Mario Tama/Getty Images)
In their letter to Gorilla Healing, the FDA stated that they had reviewed the company’s website and found that it also sells misbranded and unapproved new drugs, which violates federal law.
The FDA demanded that both companies “cease offering any unapproved and misbranded drugs for sale to U.S. consumers,” emphasizing that this action is crucial to protect the public from harm. The two firms have until the end of October to provide an explanation, and failure to do so may result in legal action by the FDA, including seizure or an injunction.
In recent months, there has been a surge in demand for Wegovy, Ozempic, and other semaglutide products in the United States and other Western countries due to the ongoing obesity crisis. Novo Nordisk had to limit the distribution of Wegovy to the U.S. market due to potential supply concerns.
FDA Warnings
In late September, the FDA announced that these drugs can lead to a potentially life-threatening condition called “ileus,” which is characterized by impaired intestinal function.
The FDA stated that some adverse reactions, including ileus, have been reported during the post-approval use of semaglutide.
“Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure,” the FDA stated on its website.
Ozempic works by mimicking the hormone GLP-1, which can slow down the passage of food in the digestive system, making people feel full for longer. However, there have been reports that the drug can slow down the intestines too much, leading to ileus and intestinal blockage.
Earlier this year, the FDA warned consumers not to use generic versions of Ozempic, Rybelsus, and Wegovy, as they may not contain the same ingredients.
According to the FDA, these generic versions of the drugs are potentially unsafe or ineffective. The agency received reports of problems associated with compounded versions of semaglutide.
“Drug compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient,” the FDA stated in June. “Compounded drugs are not FDA-approved, and the agency does not verify the safety or effectiveness of compounded drugs.”
Compounded semaglutide may contain an unapproved version of the ingredient for human use, and there have been reports of compounded semaglutide containing salt, which alters the drug’s composition.
“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 warned.
Reuters contributed to this report.
How is Novo Nordisk responding to the FDA’s warnings?
Ossible to reliably estimate their frequency or establish a causal relationship to drug exposure,” the FDA explained.
The agency recommended that healthcare professionals monitor patients receiving semaglutide for signs and symptoms of ileus, such as persistent abdominal pain, constipation, vomiting, and bloating. Patients should be advised to seek medical attention immediately if they experience these symptoms.
Novo Nordisk also released a statement in response to the FDA’s warnings, affirming their commitment to patient safety. The company stated that they are working closely with the FDA and other regulatory authorities to ensure that the benefits and risks of their products are well understood and communicated to healthcare professionals and patients.
Novo Nordisk encouraged healthcare professionals to continue prescribing the drugs in accordance with the approved labeling and to report any adverse events to the company or the FDA.
The surge in counterfeit drugs and the FDA warnings highlight the risks associated with purchasing medications online. Consumers should be cautious when buying medications from unverified sources, as counterfeit drugs can be
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