Stolen Levemir causing more adverse events, says FDA

The US Food and Drug Administration (FDA) has received multiple reports of patients suffering an adverse event due to poor control of glucose levels after using vials from stolen lots of long-acting insulin.

The agency warned patients several weeks ago not to use vials of Novo Nordisk's insulin analogue Levemir (insulin detemir) coming from a stolen shipment. At that time, the agency indicated there had been one case of a patient suffering an adverse event associated with the stolen material.

Its latest announcement indicates that the bulk of the vials of Levemir are still in circulation. The vials were stolen in North Carolina in February, but resurfaced in a hospital in Houston, Texas, in June.

Three lots with the numbers XZF0036, XZF0037, and XZF0038 - accounting for a total of 129,000 vials - were stolen in all. The lot numbers are found on the side of the box of insulin and also on the side of the vial.

So far only about 2 per cent of the affected vials have been recovered.

Health Canada also advised consumers in June not to use vials from these lots and stressed that the product is not authorised for use in Canada.

"Evidence gathered to date suggests that the stolen insulin was not stored and handled properly and may be dangerous for people to use," said the FDA in a statement published on August 26.

The FDA is advising patients who use Levemir to check their personal supply of insulin to see if they have any of the stolen material.

In addition, to guard against the possibility that the product may be repackaged, they are also advised to visually inspect insulin before using it to ensure that the product they are using is clear and colourless.