Two FDA Approved Devices Offer Alternative Treatment for Migraines
Two new devices approved by the Food and Drug Administration (FDA) could offer an alternative treatment for migraines.
This year the FDA approved the Cerena Transcranial Magnetic Stimulator and the Cefaly transcutaneous electrical nerve stimulation device as options for patients who suffer from migraines, but can't, or choose not to, take standard medication.
According to the FDA, both devices have been shown to be effective and pose minimal risks and side effects when used properly. Both devices require a prescription.
"A drug may have the potential for systemic side effects because it's ingested and metabolized. It may also have a variety of side effects that vary from person to person," said Michael Hoffmann, a biomedical engineer with FDA. "Patients have been looking for alternative migraine treatments. Because these devices aren't ingested or metabolized like drug therapies, they don't necessarily have the same types of side effects."
Some traditional drugs make patients tired, drowsy, and dizzy or affect their thinking. Since some drugs cause birth defects, pregnant woman can't use them.
Cerena is used at the onset of a migraine, while Cefaly can be used to prevent them or decrease their intensity. Neither have been tested for their safety or effectiveness for pregnant women.
Migraines are often preceded by dots, flashing lights or a blind spot called an aura. Patients use Cerena by holding it against the back of their heads while the device releases a very short magnetic pulse to stimulate the brain's occipital cortex.
Cefaly resembles a plastic headband that is used across the forehead. The device emits an electrical current to simulate one of the large nerves in the head that is associated with migraines. The 20-minute therapy is used daily.
Side effects for both devices include skin irritations, discomfort, sleepiness, dizziness and pain. The safety and effectiveness of these devices have not been established in certain populations, including children, pregnant women and people with pacemakers.