SOURCE: U.S. Food and Drug Administration, news release, Sept. 17, 2014
MONDAY, Sept. 22, 2014 (HealthDay News) -- Two new prescription devices approved by the U.S. Food and Drug Administration (FDA) may provide some relief for people with migraine headaches who don't tolerate migraine medications well, according to a new study.
One device -- the Cefaly -- is designed to prevent migraines, while the other device -- the Cerena -- is meant to be used when migraines first start, according to an FDA news release.
"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," Michael Hoffmann, a biomedical engineer with the FDA, said in the news release.
Migraines involve severe pulsing or throbbing pain in one part of the head. These intense headaches can also cause people to develop nausea and vomiting as well as sensitivity to light and sound. About one-third of people with migraines experience an aura, or visual effects such as flashing lights, dots or a blind spot, which marks the onset of the headache, said the FDA.
Migraines can last as long as 72 hours if left untreated. These headaches affect 37 million people in the United States. Although anyone -- even children -- can get migraines, women are affected more often than men, the FDA reported.
"There are many drugs to reduce migraine pain and symptoms," said Dr. Eric Bastings, a neurologist with the FDA, in the news release. "Although these drugs are quite effective, they are not for everyone. Some can make you tired, drowsy or dizzy. Some can affect your thinking. And some migraine drugs can cause birth defects; so pregnant women can't use them," he said.
The Cerena Transcranial Magnetic Stimulator can be used as soon as patients feel a migraine coming on. It's held against the back of the head. After pressing a button, a very short magnetic pulse stimulates the area of the brain that processes visual information, the FDA said.
The Cefaly transcutaneous electrical nerve stimulation device is also FDA-approved as a preventative treatment for migraine. Patients can use this device daily before a migraine develops. This portable, battery-powered device involves an electrode patch that is placed on patients' foreheads. The patch is connected to a headband. The device sets off an electrical current to stimulate a large nerve in the head that has been linked to migraines, the agency said.
"It's a set-time therapy -- running for 20 minutes and stopping automatically," Hoffmann noted.
Reported side effects for both devices were minor and resolved quickly, including:
The FDA researchers noted the safety and effectiveness of the Cerena and Cefaly have not been evaluated in use by children, pregnant women and those with pacemakers.
The U.S. National Institute of Neurological Disorders and Stroke provides more information on migraine.