Fake Ozempic pen found in US pharmacy

Novo Nordisk and the FDA have warned that counterfeit versions of the Danish pharma’s diabetes therapy Ozempic have been found in the US.

The falsified products – which are an attempt to mimic the look and feel of the genuine product’s pen injectors – have been reported shortly after knock-offs claiming to be off-brand or generic versions of the active ingredient semaglutide have been intercepted in Australia and Nigeria.

The US incident was reportedly bought at a retail pharmacy, appearing to have contained insulin glargine injection, and resulted in an adverse event. The Nigerian incident also involved a re-labeled insulin product.

Driving the demand for semaglutide products is not so much their use in diabetes, but rather the drug’s performance as an obesity therapy. Novo Nordisk sells a higher-dose version of the drug as Wegovy for weight loss, but supplies are limited and that has driven demand for Ozempic as an alternative.

“Patients prescribed semaglutide injectable products, FDA-approved and marketed under the brand names Ozempic and Wegovy, should be vigilant in checking their medicine to ensure they are taking an authentic, Novo Nordisk-produced version of the authorised drug and injection device,” said the pharma company in a statement.

It has provided the following tips to help spot a counterfeit:

Genuine:

- Genuine Novo Nordisk Ozempic pens do not extend or increase in length when setting the dose.

- The dose dial window only shows intended doses:

• On the pen intended to deliver 0.25/0.5 mg doses, it only shows -0-, 0.25 and 0.5 once dialled up to the intended doses
• On the pen intended to deliver a 1 mg dose, it only shows -0- and 1 mg once dialled up to the intended dose
• On the pen intended to deliver a 2 mg dose, it only shows -0- and 2 mg once dialled up to the intended dose

- Authentic Ozempic pens are currently available in the following configurations:

• 0.25/0.5 mg pen
• 1 mg pen
• 2 mg pen

- The box containing authentic Ozempic will include 4 needles which attach directly onto the pen, except the Ozempic 0.25/0.5 mg dose carton which has 6 needles.

Counterfeit:

- A counterfeit pen may be identified based on scale extending out from the pen when setting the dose.

- The label on a counterfeit pen could be of poor quality and may not adhere well to the pen.

- A counterfeit carton may have spelling mistakes on the front of the box (i.e., 1pen and 4 doses without space between ‘1’ and ‘pen’).

- A counterfeit carton may not include the tamper-resistant/perforation.

- The batch number printed on a counterfeit box may not correspond to the product strength stated on the same box and pen.