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NEWS BRIEFS
FDA Warns of Birth Defects with Topiramate
The US Food and Drug Administration (FDA) has issued a new warning about possible birth defects linked to topiramate (Topamax®), an antiseizure drug that is used to prevent migraine as well as treat epilepsy. The warning came after two pregnancy registries found an increased risk of oral clefts (cleft lip and cleft palate) in babies whose mothers had taken topiramate while pregnant.
"The benefits and the risks of topiramate should be carefully weighed when prescribing this drug to women of childbearing age, particularly for conditions not usually associated with permanent injury or death," an FDA statement said. "Alternative medications that have a lower risk of oral clefts and other adverse birth outcomes should be considered for these patients. If the decision is made to use topiramate in women of childbearing age, effective birth control should be used. Oral clefts occur in the first trimester of pregnancy before many women know they are pregnant."
Oral clefts were seen in 1.4% of infants who were exposed to topiramate in the first trimester, according to the North American Antiepileptic Drug Pregnancy Registry, compared to 0.38-0.55% in infants exposed to other antiepileptic drugs and 0.07 percent where no antiepileptic drugs were used. The UK Epilepsy and Pregnancy Register found an oral cleft prevalence of 3.2% in infants exposed to topiramate, compared to a rate of 0.2% in the general population.
Topiramate has been moved to a Pregnancy Category D drug, meaning there is evidence of human fetal risk based on human data, but that the drug's benefit may outweigh the risks in some situations.
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Significant Increase in Migraine Rate Seen
Migraine rates rose by 1% in Norway over the last decade. While that may sound like a small increase, if the same is true in the U.S., 3 million more Americans now suffer from migraine headaches.
The findings were from one of the largest and most comprehensive health studies in the world, performed by the Norwegian University of Science and Technology (NTNU). In their survey of 74,000 people done between 1995 and 1997, 12.1% of the population had migraine. By the 2006-08 survey, that figure had gone up to 13.2%, representing roughly 45,000 more Norwegians.
"Those are real numbers and give some cause for concern," said NTNU researcher Professor Knut Hagen. "The increase has also occurred over a relatively short period of time."
Hagen and his colleagues are perplexed by the finding, since there is no apparent scientific explanation. The diagnostic criteria for migraine haven't changed, nor have the level of self-reported migraine or the number of migraines caused by medicines.
Prof. Hagen speculates that changes in the environment are behind the rise. "From experience we know that visual impacts, such as flickering screens, can trigger migraines. Measurements of the neurophysiological activity in the brain with EEG show that migraine patients are more susceptible to light stimulation. It is tempting to believe that the increase in migraines is due to the increase in these kinds of stimuli during the 11 years between the two … surveys."
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Effect of Botox® on Cervicogenic Headache "Not Significant"
While some studies have suggested that Botox (onabotulinum toxin A) could improve cervicogenic headaches, a new, more rigorous study has found no significant difference between Botox and placebo injections.
Cervicogenic headaches originate in the occipital regions of the neck and are accompanied by limited range of motion. They are diagnosed by reproducing the symptoms with positional maneuvers and relieved with a diagnostic occipital nerve block.
The randomized, placebo-controlled, blinded crossover study included 28 adults with long-standing and treatment-resistant cervicogenic headaches. Patients received injections of Botox or of saline at fixed sites in the neck muscles on the same side as their pain. At least eight weeks later, patients received a second round of injections and were then followed for another eight weeks. At the end, there was no significant reduction seen in moderate-to-severe headache days, neck mobility or quality of life.
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Double-Jointedness Triples Migraine Risk
Being extremely flexible comes at a cost—people with what's called joint hypermobility syndrome are three times more likely to have migraine. In fact, in the first study to fully research the link, 75% of double-jointed people experienced migraine headaches. Not only that, they had twice as many migraine days per month and were more likely to have migraine with aura.
Joint hypermobility syndrome is a disease of the collagen (the main component of connective tissue). Study lead Vincent Martin, MD, professor at the University of Cincinnati College of Medicine in Ohio (and a NHF board member), theorizes that overly elastic collagen leads to both flexible joints and stretchy blood vessels, the latter being an issue with migraine.
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Childhood Migraine Linked to Adult Weight Gain
Early migraine may mean later weight gain for some women. According to a University of Washington study, 40% of women who had migraine as children or adolescents had gained at least 22 pounds since age 18, compared to 30% of women who never had migraines.
The findings were drawn from a study of 3,700 pregnant women who were asked their height and weight at age 18 and then again just before they became pregnant, and whether they had been diagnosed with migraine. About 25% of the women who were obese had migraine compared to 17% of the women of normal weight.
Study lead Michelle A. Williams said the findings hinted that weight and migraines may fuel each other in some way, according to a Reuters Health story. While more research is needed, Williams said, "I would endorse the advice offered by the Centers for Disease Control and Prevention that promotes a lifestyle that includes healthy eating, regular physical activity, and avoidance of adult weight gain."
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A SAMPLING FROM OUR MAILBAG
Treating Headaches with Magnetic Stimulation
Q. Have you heard about the use of magnetic stimulation to treat headaches?
A. Transcranial magnetic stimulation (TMS) is a technique that applies a brief magnetic pulse to the scalp and underlying brain. It was evaluated for the treatment of migraine based on the theory that a fluctuating magnetic field applied to the scalp would induce an electrical current. This current would then disrupt the spread of abnormal brain currents called cortical spreading depression (CSD). CSD is thought to occur in people who have migraine with aura, though it may occur in those with migraine without aura. Animal studies suggest that CSD can trigger pain receptors in the membranes that cover the brain.
One small randomized, double-blind, sham-controlled trial has evaluated the use of single-pulse transcranial magnetic stimulation in 164 patients with migraine with aura. More patients who received the TMS treatment were pain-free at two hours than those who received the sham treatment (39% vs. 22%). The trial was not able to show a reduction of pain from moderate/severe to mild/no headache. Trials with many more patients are needed to evaluate safety concerns as it is theoretically possible that TMS could trigger seizures.
Barbara Lee Peterlind, DO
Drexel University of Medicine
Philadelphia, PA
Curious about what other readers are asking our team of headache specialists? Be sure to read NHF HeadLines, the 16-page quarterly journal of the National Headache Foundation. It's available to all NHF members. If you're not a member, join today.
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