Insulin stolen in U.S. linked to health problems

The FDA has received reports of patients who suffered unsafe blood-sugar levels after using a vial from one of the stolen lots of Levemir insulin.(Courtesy FDA)

People with diabetes should avoid using certain vials of insulin made by Novo Nordisk that were stolen earlier this year and have been linked to unsafe blood-sugar levels, U.S. regulators said Wednesday.

The U.S. Food and Drug Administration said in June that three lots of Novo Nordisk's Levemir insulin were stolen in North Carolina. Since then, the FDA has received three reports of patients who suffered unsafe blood-sugar levels after using a vial from one of the stolen lots.

Health Canada also advised consumers in June not to use lot numbers:

• XZF0036.
• XZF0037.
• XZF0038.

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

Only about two per cent of the 129,000 affected vials have been returned, the FDA said.

Not authorized for sale in Canada

Levemir insulin is used to treat Type 1 diabetes in adults and children, and Type 2 diabetes in adults who need long-acting insulin to control high blood sugar. It is given by injection and comes in 10-ml vials.

The products are not authorized for sale in Canada and have not been found for sale in the Canadian marketplace, but travellers may have bought them in the U.S. or over the internet, Health Canada said.

Canadians with the product are advised not to use it, and check with their health-care professional if they have any concerns.

A spokesperson for Health Canada said Wednesday no additional information was available, and that the department will provide an update if required.

The FDA advised patients to replace vials from the three lots with a vial of Levemir from another lot. The lot numbers are found on the side of the box of insulin and also on the side of the vial.

"If you must switch to another brand of insulin for any reason, first contact your health care provider because another insulin product may require adjustments in dosing," the FDA said Wednesday.

People should always look at their insulin carefully before using it, the FDA said, noting levemir is a clear and colorless solution.

The FDA continues to investigate the theft.

A spokesperson from Novo Nordisk's U.S. headquarters in Princeton, N.J., said the company is cooperating with the FDA. The company is based in Denmark.

With files from The Associated Press