A counterfeit medication was reportedly purchased at a retail pharmacy, appearing to have contained another type of diabetes medication that led to an adverse reaction.
The FDA and Novo Nordisk have reported that a counterfeit semaglutide injection (Ozempic) pen was found in the United States. According to a company press release, the medication was reportedly purchased at a retail pharmacy, appearing to have contained another type of diabetes medication called insulin glargine injection, which works differently than semaglutide and lead to an adverse event (AE).
Novo Nordisk has been working with the FDA to investigate the origin and distribution of the counterfeit pen. The company has issued a statement that individuals who have obtained semaglutide injectable products that are FDA-approved under the brand names Ozempic and Wegovy (Novo Nordisk) should make sure they are taking an authentic product of the authorized drug and injection device. The statement said that the safety and efficacy of the counterfeit products cannot be assured and should not be used as serious AEs can occur.
Additionally, the statement said that medications purchased online or in-person from foreign or unlicensed sources could have a variety of issues, including products that are misbranded, adulterated, counterfeit, contaminated, improperly stored or transported, ineffective, and/or unsafe. The company added that using these medications could be putting the patient and their health at risk.
To determine whether a Novo Nordisk Ozempic pen is genuine, look for:
Counterfeit pens can be identified:
Although there have been no counterfeit Wegovy pens reported to date in the United States, Novo Nordisk cautions consumers and pharmacies about the possibility of counterfeit Wegovy.
Genuine Wegovy pens have fixed-dose auto-injectors and do not have a push to administer button. Additionally, they do not have an option to set a dose or extend/increase in length.
Wegovy is currently available in 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, and 2.4 mg pens.
The company suggests that retail pharmacies and consumers should purchase medication through authorized distributors and reliable sources. Pharmacists should review the photographs and information detailing counterfeit medication to confirm the dispensing medication is authentic. Patients should also check the product before use, according to the statement.
The company said that any patients experiencing AEs related to the use of counterfeit products should discontinue the medication immediately and contact their physician.
To report AEs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program, call 1-800-FDA-1088 or visit www.fda.gov/medwatch.
To report counterfeit semaglutide products or suspected Novo Nordisk products, Novo Nordisk urges individuals to call their customer care line at 1-800-727-6500 Monday through Friday from 8:30 am to 6 pm EST.
Additionally, all websites that are selling counterfeit and/or tampered medications should be reported to the FDA’s Office of Criminal Investigation at 800-551-3989 or at a local Office of Criminal Investigation field office.
Novo Nordisk warns of counterfeit Ozempic (semaglutide injection) pen found in US. News release. Novo Nordisk. June 16, 2023. Accessed June 20, 2023. https://www.novonordisk-us.com/content/nncorp/us/en_us/media/news-archive/news-details.html?id=166119