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Thought there was no hope for treating your migraine headaches? Don’t give up.
In the past year, the Food and Drug Administration has given adults new options for treating migraines by allowing the marketing of two prescription devices for such headaches. People who don’t tolerate drug treatments well might find relief by using the Cerena Transcranial Magnetic Stimulator or the Cefaly transcutaneous electrical nerve stimulation device. Both devices have been shown in clinical studies to be effective and pose minimal risks and side effects when used according to their labeling.
There’s a great need for these noninvasive devices because many anti-migraine drugs have side effects that some patients can’t tolerate, says Michael Hoffmann, a biomedical engineer with FDA.
“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,” Hoffmann explains. “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.”
Migraine headaches are characterized by intense pulsing or throbbing pain in one area of the head accompanied by nausea and/or vomiting and sensitivity to light and sound. A migraine can last four to 72 hours when untreated. According to the National Institutes of Health (NIH), 12 percent of Americans (about 37 million people) have migraines. These debilitating headaches affect children and adults, and women are three times more likely to have migraines than men (about 18 percent of women have migraines).
About one-third of people with migraines experience an aura—visual disturbances such as dots, flashing lights or a blind spot—that signals the beginning of the headache. Cerena is the first medical device granted marketing by FDA to relieve pain caused by migraine headaches that are preceded by an aura.
Patients use Cerena when they feel a headache coming on or when the pain begins. Using both hands to hold the device against the back of the head, the patient presses a button to release a very short (less than one second) magnetic pulse to stimulate the brain’s occipital cortex (the back part of the brain that processes visual information). Transcranial Magnetic Stimulator (TMS) technology, used in the Cerena device, has been studied for quite some time but has only recently been authorized for specific clinical uses.
Cefaly is the first transcutaneous (passing through the skin) electrical nerve stimulation (TENS) device granted marketing by FDA for use before the onset of a migraine, as a preventive treatment for migraine headaches. Patients can use Cefaly daily, and the treatment has been shown to reduce the number of days during which they experience migraines. TENS technology has been around a long time as a treatment for general pain, but this is the first time it’s been authorized as a preventive measure for migraines.
The portable, battery-powered Cefaly device resembles a plastic headband worn across the forehead. The user applies an electrode (a patch) to the forehead, connects the plastic headband to the electrode, and the device then emits an electrical current to stimulate one of the large nerves in the head (the trigeminal nerve), which has been associated with migraines. “It’s a set-time therapy—running for 20 minutes and stopping automatically,” Hoffmann says.
Both devices’ side effects include skin irritations, discomfort, sleepiness, dizziness and pain at site of application. These issues weren’t reported often and were resolved quickly, Hoffmann says. For example, in a telephone poll of more than 2,000 European users of Cefaly, 95 percent did not report any complaint with using the device. But the safety and effectiveness of these devices have not been established in certain populations, including children, pregnant women and people with pacemakers.
Although there are effective drug treatments for migraines, they can have side effects. Medical devices aim to provide an alternative treatment with fewer and more tolerable side effects.
There are many drugs to reduce migraine pain and symptoms, says Eric Bastings, M.D., a neurologist at FDA. “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 adds. “It’s important to note that medical devices have some limitations as well, and that the safety and efficacy of Cefaly and Cerena have not been established in pregnant women.”
Many people who have frequent or severe migraines may use preventive medications, including beta-blockers such as propranolol. Beta-blockers, which slow the heart rate, are used mostly to treat heart conditions. “These medications aren’t for migraine patients who have asthma, some lung problems or slow heart rate,” Bastings warns.
Certain antiepileptic drugs, such as topiramate and divalproex sodium, are also prescribed for migraines. These seizure medicines, when they are taken regularly, may help to reduce the number of migraine headaches, but rarely eliminate them completely.
Migraines are often underdiagnosed and undertreated. Bastings advises patients to tell their health care providers about their headaches and to see a doctor who specializes in migraines if they don’t get adequate relief. “Doctors should be aware of the drugs approved for migraines and of alternative treatment options,” he adds.
These devices present another choice that patients can discuss with their doctors, Hoffmann says. “Now patients have more options and hopefully can find the one that works best for them.”
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
September 17, 2014