After the Food and Drug Administration (FDA) approves a product and it is on the market, FDA continues to monitor unexpected and undesirable side effects (adverse events) of that product.
Health care professionals and consumers may report side effects, product quality problems, product use errors, or therapeutic failure with the use of medical products to FDA's MedWatch Adverse Event Reporting program either online, by regular mail, by fax, or by phone.
Online at https://www.accessdata.fda...
Insulin pens are pen-shaped injector devices that contain a disposable needle and either an insulin reservoir or an insulin cartridge. The devices typically hold enough insulin for a patient to self-administer several doses of insulin before the reservoir or cartridge is empty.
All insulin pens are approved only for single-patient use (one device for only one patient). They are designed to be safe for one patient to use one pen multiple times with a new, fresh needle for each injection.
Why has FDA issued this alert?
FDA knows of incidents at two undisclosed hospitals involving more than 2,000 people in which the cartridge component of the insulin pens was used to administer insulin to multiple patients, although the disposable needles were reportedly changed among patients.
Who has been affected by these incidents?
Patients who have been exposed to shared insulin pens are being contacted by the two hospitals and are being offered testing for hepatitis and HIV. Some of the potentially exposed patients have reportedly tested positive for the hepatitis C virus, although it's not known if the virus was spread as a result of insulin pen sharing.
FDA, the Centers for Disease Control and Prevention, and professional organizations are working to address infection control issues related to insulin pens.