Sensor glucose values with use of Hydroxyurea medication

If you are actively taking a medication named Hydroxyurea, used to treat some cancers and sickle cell anemia, your sensor could present inaccurate sensor glucose (SG) readings. Because your safety is our top priority, we are making you aware of this issue and important actions. Consult your healthcare professional if you are taking Hydroxyurea and using a CGM. Medtronic has not received any complaints or reports of patient harm or injuries due to this issue.

Explanation of issue:
Hydroxyurea is used to treat certain diseases, such as cancer and sickle cell anemia. Hydroxyurea is also known by other names, such as hydroxycarbamide, Hydrea™*, Droxia™*, and Siklos™*. Hydroxurea use results in higher SG readings compared to blood glucose (BG) readings and may result in the following:

• Hypoglycemia caused by over-administration of insulin
• Inaccurate graphs or missed alarms and alerts
• Delay to or loss of sensor-enabled insulin suspension (sensor-enabled insulin pump use only)
• SG readings in CareLink™ reports being substantially higher than BG readings

What you should do:

• Do not use continuous glucose monitoring (CGM) while taking hydroxyurea.
• Only use your BG meter to monitor glucose levels while taking hydroxyurea.
• Consult with your healthcare professional if you are taking hydroxyurea and using a CGM.
• When using an insulin pump system, disable the CGM feature by going to the sensor settings. Refer to the user guide that came with your insulin pump for instructions.
• Always check the label of any medication to confirm with your healthcare professional whether hydroxyurea or hydroxycarbamide is an active ingredient.

What Medtronic is doing:

Medtronic is working to update instructions for use of CGM sensors to include warnings about use of CGM while taking Hydroxyurea.

At Medtronic, patient safety, awareness and customer satisfaction are our top priorities. We apologize for any inconvenience this issue may cause you and appreciate your time and attention in reading this important notification.

As always, we are here to support you. If you have further questions or need assistance, please call 24-Hour Technical Support line at: 800-646-4633, option 1.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

† Includes these variants for Enlite™ sensors (MMT-7008A, MMT-7008B) and Guardian™ Sensor 3 sensors (MMT-7020LA, MMT-7020LB, MMT-7020LPA, MMT-7020A, MMT-7020B, MMT-7020GA, MMT-7020Y, MMT-7020YL)