Counterfeit Ozempic Pens Pose Serious Health Risks, Prompting FDA Investigation
ICARO Media Group
Thousands of fake Ozempic pens have been seized in the United States, leading to a nationwide shortage of the drug and putting patients at risk. The American Association of Poison Control Centers (AAPCC) reported three cases last year of individuals injecting themselves with suspected counterfeit versions of Ozempic, resulting in hypoglycemia or low blood sugar. This serious condition can lead to seizures, coma, and even death if the brain is deprived of sugar for an extended period.
The rising demand for Ozempic has created a market for counterfeit drugs, which are often ordered online. These fake versions, packaged to resemble the genuine product, do not contain the active drug, semaglutide. Instead, they are often insulin pens that cause a rapid drop in blood sugar levels when injected. The AAPCC did not disclose further details regarding the patients but indicated that all three cases were reported from the same poison center.
Compounding the issue, a patient treated by the AAPCC last year had used a compounded version of Ozempic. Compounded drugs are created by pharmacies when there is a shortage of a medication. The Food and Drug Administration (FDA) is currently investigating the cases reported by the AAPCC, which operates 55 centers across the US.
Last year, the FDA seized thousands of fake Ozempic pens, primarily from warehouses outside the legitimate supply chain. To ensure their safety, the FDA advises Americans to purchase Ozempic only from licensed pharmacies. Patients are urged to check the product for any signs of counterfeiting before use.
While the AAPCC did not disclose the number of serious cases, separate FDA data suggests that two deaths and three hospitalizations are potentially linked to counterfeit Ozempic. Reports of fake pens have emerged from countries such as Austria, Lebanon, and the UK. Health authorities in Austria and Lebanon reported cases of hypoglycemia among individuals who had taken suspected counterfeit Ozempic.
The dangers posed by counterfeit Ozempic extend beyond the absence of the active ingredient. There are concerns that the fake pens may not be sterile, increasing the risk of contracting diseases like HIV or hepatitis. Counterfeit drugs have also been discovered to contain insulin or saline solution instead of semaglutide, as verified by health regulators in Belgium.
Novo Nordisk, the manufacturer of Ozempic, has stated that it is unaware of the details of these cases as they were reported directly to the poison control centers. The AAPCC received over 3,000 reports related to Ozempic last year, but the vast majority were non-serious complaints known to be side effects of the drug, such as nausea and vomiting.
Hypoglycemia is listed as a potential side effect of Ozempic, particularly for patients using the drug alongside insulin. Symptoms can range from headaches and dizziness to loss of consciousness or seizures. The AAPCC has not disclosed how the three cases of counterfeit semaglutide were identified, but they often receive such information from medical providers who treat the patients and obtain samples of the medicine.
Novo Nordisk reported last year that some samples of compounded semaglutide were found to be up to 33% impure. These findings highlight the urgency of the FDA investigation into counterfeit Ozempic pens and the importance of obtaining medication from reputable sources to ensure patient safety.