FDA issues warning on Levemir insulin
Stolen vials of the long-acting insulin Levemir made by Novo Nordisk have reappeared and are now being sold in the U.S.. the U.S. Food and Drug Administration has learned.
The insulin may be dangerous because the vials may not have been stored and handled properly, the FDA warns.
Three lots or a total of 129,000 vials of this product were stolen in all, the agency said.
The agency is advising patients who use Levemir insulin to:
1. Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036, XZF0037, and XZF0038. Patients can locate the lot number on the side of the box of insulin and also on the side of the vial.
2. Do not use your Levemir insulin if it is from one of these lots. Replace it with a vial of Levemir insulin from another lot. If you must switch to another brand of insulin for any reason, first contact your healthcare provider as another insulin product may require adjustments in dosing.
3. Always visually inspect your insulin before using it. Levemir is a clear and colorless solution.
4. Contact the Novo Nordisk Customer Care Center at 800-727-6500 for what to do with vials from these lots or if you have any other questions.
For the full FDA advisory and the Novo Nordisk, Inc. press release continue.
FDA Issues Public Health Advisory Regarding Levemir Insulin
The U.S. Food and Drug Administration has learned that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. have reappeared and are being sold in the U.S. market.
Three lots or a total of 129,000 vials of this product were stolen in all.
These stolen insulin vials may not have been stored and handled properly and may be dangerous for patients to use.
The FDA has received one report of a patient who suffered an adverse event due to poor control of glucose levels after using a vial from one of these three lots.
The agency is advising patients who use Levemir insulin to:
1. Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036, XZF0037, and XZF0038. Patients can locate the lot number on the side of the box of insulin and also on the side of the vial.
2. Do not use your Levemir insulin if it is from one of these lots. Replace it with a vial of Levemir insulin from another lot. If you must switch to another brand of insulin for any reason, first contact your healthcare provider as another insulin product may require adjustments in dosing.
3. Always visually inspect your insulin before using it. Levemir is a clear and colorless solution.
4. Contact the Novo Nordisk Customer Care Center at 800-727-6500 for what to do with vials from these lots or if you have any other questions.
Company Press Release:
Novo Nordisk Warns Customers About Stolen Insulin
PRINCETON, N.J., June 13 /PRNewswire-FirstCall/ — Novo Nordisk product previously reported as stolen in North Carolina has resurfaced recently at a medical center in Houston.
Three lots of 10 ml vials of insulin, marketed under the brand name Levemir® (insulin detemir [rDNA origin] injection), were taken in the original theft and identifiable by the following lot numbers: XZF0036, XZF0037, XZF0038.
A vial or vials of stolen insulin from lot XZF0037 was discovered this week at a medical center in the Houston area. Insulin from these lots did not circulate through the normal Novo Nordisk distribution channel and therefore proper storage conditions for the insulin may not have been followed.
Patients can locate the lot number on the side of the box of insulin or the side of the vial. If a patient finds their insulin is from one of the stolen lots, they should not use the insulin and contact Novo Nordisk Customer Care Center at 1-800-727-6500 for further information and instructions.
The safety of our patients is of paramount concern and we are working with our partners, the pharmacy, the FDA and law enforcement authorities to investigate the situation and take immediate steps to maintain the highest standard of safety and quality for our products.
About Levemir® (insulin detemir [rDNA origin] injection)
Levemir® is indicated for once- or twice-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia.
Important safety information
Levemir® is contraindicated in patients hypersensitive to insulin detemir or one of its excipients.
Hypoglycemia is the most common adverse effect of all insulin therapies, including Levemir®. As with other insulins, the timing of hypoglycemic events may differ among various insulin preparations. Glucose monitoring is recommended for all patients with diabetes. Levemir® is not to be used in insulin infusion pumps. Any change of insulin dose should be made cautiously and only under medical supervision. Concomitant oral antidiabetes treatment may require adjustment.
Inadequate dosing or discontinuation of treatment may lead to hyperglycemia and, in patients with type 1 diabetes, diabetic ketoacidosis. Levemir® should not be diluted or mixed with any other insulin preparations. Insulin may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy. Dose and timing of administration may need to be adjusted to reduce the risk of hypoglycemia in patients being switched to Levemir® from other intermediate or long-acting insulin preparations. The dose of Levemir® may need to be adjusted in patients with renal or hepatic impairment.
Other adverse events commonly associated with insulin therapy may include injection site reactions (on average, 3% to 4% of patients in clinical trials) such as lipodystrophy, redness, pain, itching, hives, swelling, and inflammation. Less common, but more serious are severe cases of generalized allergy, including anaphylactic reaction, which may be life threatening.
Levemir® is a registered trademark of Novo Nordisk A/S.
About Novo Nordisk
Novo Nordisk is a healthcare company with an 86-year history of innovation and achievement in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition to diabetes care, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy, and hormone therapy for women. Novo Nordisk’s business is driven by the Triple Bottom Line: a commitment to social responsibility to employees and customers, environmental soundness and economic success. With headquarters in Denmark, Novo Nordisk employs more than 27,900 employees in 81 countries, and markets its products in 179 countries. Novo Nordisk’s B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol ‘NVO’. For global information, visit novonordisk.com; for United States information, visit novonordisk-us.com.
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