THIS MEDICAL DEVICE MAY CAUSE HARM TO YOUR BABY:
It is important to talk to your doctor before using Cefaly if you are pregnant or planning to become pregnant. There have been no human studies that have looked at the safety of Cefaly during pregnancy or while breastfeeding.
What is Cefaly?
Cefaly is a a portable, low voltage medical device known as a transcutaneous electrical nerve stimulator (TENS), specifically an external trigeminal nerve stimulator (eTNS). It is currently only available by prescription from a doctor. Cefaly was approved by the FDA in 2016. It may be used in combination with medications. It is available as the CEFALY PREVENT for prevention of episodic migraines and CEFALY ACUTE for prevention and acute treatment of episodic migraine.
What is Cefaly used to treat?
Cefaly PREVENT is used to prevent episodic migraine headaches in adults. Cefaly ACUTE is used to prevent and treat acute migraines with or without aura in adults. Migraine headache is characterized by episodes of pain lasting more than 2 hours, desire to be still or silent, and changing location of pain between episodes. Compared to chronic migraine, episodic migraine is characterized by fewer migraine days per month as well as a lower duration and severity of migraines.
How does Cefaly work?
Cefaly is a noninvasive device that is placed on the front of the head (it should not be placed on the neck or chest). The device works by sending low voltage electrical impulses to the trigeminal nerve; the trigeminal nerve runs from the brain to the eye area and face. The electrical impulses may suppress pain signaling in the brain.
If I am taking Cefaly, can it harm my baby?
The manufacturer of Cefaly states that women who become pregnant or are pregnant should talk with their doctor before using Cefaly. There have been no studies evaluating the safety and efficacy of Cefaly in pregnant women. There is limited safety information related to the regular use of this device and patients with implantable medical devices, recent brain or facial trauma or abrasion should not use this device. Potential adverse effects associated with this device may include skin irritation, injury or burn, numbness, drowsiness, worsening headache, and lack of migraine relief.
If I am taking Cefaly and become pregnant, what should I do?
If you are using Cefaly 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 taking Cefaly, can I safely breastfeed my baby?
There is no available information on the safety of Cefaly in women who are breastfeeding.
If I am taking Cefaly, will it be more difficult to get pregnant?
There have been no studies in men or women that have looked at the effects of Cefaly on fertility.
If I am taking Cefaly, what should I know?
The safety and efficacy of Cefaly have not been studied in pregnant women or women who are breastfeeding. The manufacturer of Cefaly 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 Cefaly during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.
You may find Pregistry's expert report about migrain headaches here, pain here, the individual medications used to treat pain here, and our reports about neurological disorders and the medications used to treat them here. Additional information can also be found in the resources below.
For more information about Cefaly during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following links:
American Migraine Foundation: Cefaly for Migraine Prevention
U.S. Food and Drug Administration: Cefaly ACUTE 510K Summary
U.S. Food and Drug Administration: Cefaly 510K Summary
Cefaly: Cefaly Frequently Asked Questions