FDA Warning on Using Ozempic: Missing a dose can cause an overdose

2024-07-30 12:20:37

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The Food and Drug Administration (FDA) warns healthcare providers and patients about errors in the dosage of compounded parts of the drug. weight loss medicine Ozempic, produced by the Danish laboratory Novo Nordisk. The agency has received reports of overdoses in patients who they take up to 20 times the prescribed dose.

The FDA did not specify the number of reports, but it reported that the dosage errors involved increased semaglutide, the active ingredient in Ozempic and Wegovy. Some affected patients require medical attention or even hospitalization.

Most reports note that patients have improperly drawn more than the prescribed dose from multi-dose vials while self-administering the medication. In other cases, patients take between five and 20 times the prescribed dose, as reported by the FDA in your account.

Adverse events caused by these errors include nausea, abdominal pain, nausea, acute pancreatitis, and gallstonesamong other things.

Adverse events caused by these errors include nausea, abdominal pain, fainting, acute pancreatitis, and gallstones, among others (File)Shutterstock

Also, reports suggest that many patients are not familiar or educated to it their dosage well with a syringe. One patient reported problems understanding instructions provided by your healthcare provider.

Cases are also described where health care providers prescribe wrong needle. A supplier 25 parts are given instead of 5and another 20 units are given instead of 2, which causes the patient to experience nausea and vomiting.

Last year, the FDA warned against the combined use of semaglutide, recommending that patients avoid compounded medicine maybe there is an approved version. Common medicines They are not regulated or approved by the FDA, which prevents the agency from ensuring their safety. The FDA recommends caution when purchasing semaglutide products, as some may not contain the same active ingredients as approved drugs and may include salt formulations, which are “not safe or effective.” The FDA explained in another statement.

The Institute recognizes the great interest of consumers in using compound semaglutide products for those recent weight loss. However, these drugs pose a greater risk to patients compared to FDA-approved drugs because they do not undergo premarket review to evaluate their safety, effectiveness, or quality. Therefore, only combined drugs should be used when the patient’s medical needs cannot be met with an FDA-approved drug.

In the last year, Novo Nordisk has been sued a lot medical spas, wellness clinics and pharmacies for selling the compounded versions of Ozempic and Wegovy, which occasionally appear on the FDA drug shortage list, Forbes reported in a newspaper article.

FDA reports suggest that many patients are not familiar with or trained to measure the correct dose with a syringe (File)GETTY pictures

The FDA asks manufacturers, healthcare providers, and patients to report adverse events and medication errors associated with semaglutide products submitted to the FDA’s MedWatch adverse event reporting program. For this, we ask you to complete and submit an online report in MedWatch of the FDA Safety Information and Bacterial Incident Reporting Program. You can also download it layout and Fax to 1-800-FDA-0178.

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