THIS MEDICAL DEVICE CAN CAUSE HARM TO YOUR BABY:
gammaCore should not be used during pregnancy. There have been no human studies that have looked at the safety of gammaCore during pregnancy or while breastfeeding.
What is gammaCore?
A portable, low voltage medical device used to control the symptoms of pain associated with headaches in adults, gammaCore is currently only available as a prescription device. This medical device is known as a non-invasive vagus nerve stimulator, and was approved as a new device type by the FDA in 2017. It may be used in combination with medications.
What is gammaCore used to treat?
The gammaCore device is used to treat acute pain associated with migraine headache and episodic cluster headaches (this device has not been shown to be effective for treating chronic cluster headache). Cluster headache is a headache disorder characterized by severe headaches that occur in a series (for example, every other day up to several times a day) and last for 15 minutes to 2 hours, followed by a period of remission (more than 1 month between clusters). Symptoms of a cluster headache include severe nerve pain on one side of the head and near the eyes or temple. A cluster headache is considered the most painful type of headache. Patients may also experience other symptoms including red eyes, tearing, facial sweating, droopy eyelids, runny nose, congestion, or restlessness. Cluster headache is differentiated from migraine headache based on symptoms and severity. Migraine headache is characterized by episodes of pain lasting more than 2 hours, desire to be still or silent, changing location of pain between episodes, and a lack of the facial symptoms associated with cluster headache.
How does gammaCore work?
It is a noninvasive device that is placed on the side of the neck. The device works by sending low voltage electrical impulses to the vagus nerve; the vagus nerve runs from the brain to the face, neck, chest, and stomach. The electrical impulses may suppress pain signaling in the brain.
If I am using gammaCore, can it harm my baby?
The manufacturer of gammaCore warns that there have been no studies evaluating the safety and efficacy of gammaCore in pregnant women and this medical device is not recommended during pregnancy. There is limited safety information related to the chronic use of this device – patients with uncontrolled high blood pressure, seizures, implantable medical devices, heart disease, or other abnormal heart rhythm should not use this device. Potential adverse effects associated with this device may include dizziness, shortness of breath, chest pain, sweating, worsening headache, and skin irritation.
If I am using gammaCore and become pregnant, what should I do?
If you are using gammaCore and become pregnant, you should contact your doctor immediately. Your doctor will determine if your medical device is medically necessary, or if it should be discontinued until after the birth of your baby.
If I am using gammaCore, can I safely breastfeed my baby?
There is no available information on the safety of gammaCore in women who are breastfeeding.
If I am using gammaCore, will it be more difficult to get pregnant?
There have been no studies in men or women that have looked at the effects of gammaCore on fertility.
If I am using gammaCore, what should I know?
The safety and efficacy of gammaCore have not been studied in pregnant women or women who are breastfeeding. The manufacturer of gammaCore does not recommend use of this medical device during pregnancy.
If I am taking any medication, what should I know?
This report provides a summary of available information about the use of gammaCore during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.
You may find Pregistry's expert reports about pain and the individual medications used to treat pain here, and our reports about neurological disorders, including migraine headaches, and the medications used to treat them here. Additional information can also be found in the resources below.
For more information about gammaCore during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following links:
American Migraine Foundation: Cluster Headache.
Mayo Clinic: Vagus Nerve Stimulation.
ElectroCore: gammaCore Instructions for Use