MEDICAL PRODUCT ALERT 2 - FALSIFIED OZEMPIC (SEMAGLUTIDE) INJECTION IN GHANA

Alert Summary

The Food and Drugs Authority (FDA), Ghana reports of falsified Ozempic Injection detected during Market Surveillance (MS) activities in Pharmacies in Accra . Ozempic is a clear and colourless or almost colourless solution indicated for the treatment of adults with insufficiently controlled Type 2 Diabetes Mellitus as an adjunct to diet and exercise. The active ingredient in Ozempic is Semaglutide.

The falsification of Ozempic has been confirmed by the Ghana Country Representative of Novo Nordisk. The FDA has also taken the necessary regulatory sanctions against the facilities where the medical products were found including seizure of the medicines.

How to identify falsified Ozempic (Semaglutide) Injection

To identify genuine and falsified Ozempic, check for the following:

• The type of pen used for falsified Ozempic differs from the genuine Novo Nordisk FlexTouch pen in that the scale on the falsified pen goes from 0 to 80 and the dose selector prolongs when setting the dose. This is different from the genuine Novo Nordisk Ozempic pen, which does not prolong and increase in length when setting the dose.

• The scale drum increments are fixed on the genuine Ozempic pen and doses according to the instruction for use. For example, if you are prescribed Ozempic and the dose you will need to inject is 0.25mg, you will dial up until the scale drum shows 0.25mg.

Please refer to the attachment of this Alert for details of the genuine and falsified Ozempic

Risks

• Using falsified Ozempic could result in ineffective treatment or pose serious or life-threatening risks to patients' health

• Users of falsified Ozempic may end up with hypoglycemia and seizure as possible serious side effects

• Some of the falsified Ozempic pens tested by the manufacturer; Novo Nordisk revealed that the medical product contains insulin as the active ingredient and Semaglutide.

Advice to healthcare professionals, regulatory authorities and the public

The FDA is informing all healthcare professionals and the general public that the manufacturer of Ozempic has not registered the medical product in Ghana. If you are in possession of the falsified product, the FDA recommends that you do not use them and return them to the nearest FDA office or health facility. If you, or someone you know, has, or may have used falsified Ozempic, or suffered an adverse event or unexpected side-effect after use, seek immediate medical advice from a healthcare professional or contact the FDA in any of our offices or through our social media handles.