Jun 26 2005
A Florida researcher reports that a prescription nasal spray approved for adults with migraines also helps teenagers and potentially offers relief for a population which is underserved in this respect.
Paul Winner, a neurologist and director of the Palm Beach Headache Center, says that teens who took zolmitriptan nasal spray (Zomig) for their headache pain were nearly three times more likely to find relief from pain within an hour compared to those given a placebo.
Winner says that though this research is preliminary, it is important because while there are seven FDA-approved drugs to treat migraines in adults, there are none for teens, who are presently forced to rely on often ineffective over-the-counter medications for pain relief.
According to Winner there is a complete lack of awareness that children have headaches at all, let alone migraines, and this is a dramatically under-diagnosed and under-treated population.
He says more research is needed to find appropriate FDA-approved, specific treatment for migraines for this group.
The neurologist suggests that because most teen migraines are shorter in duration than those of adults, lasting four to six hours compared to adults whose headaches often last for several days, the severity of headaches in those between the ages of 12 and 17 has tended to be dismissed.
Also in this group their headaches mean time off school rather than missing work which could be another reason for the neglect of this group.
Winner says that more than one in 10 U.S. teens, an estimated 8 million to 12 million adolescents, get migraines, most during the day, and the headaches can severely impair their lives.
The double-blind study included 171 adolescents with migraines who had received no relief from placebo nasal spray. Half then received zolmitriptan nasal spray and half more of the placebo nasal spray.
After an hour, 28 percent of those who had taken the prescription medicine while suffering an attack were pain-free compared to only 10 percent of the placebo group. Further, 51 percent of the children who took zolmitriptan were able to resume their normal activities, while 38 percent of the placebo group were comfortable doing so. Two hours after taking the spray, the 39 percent of the zolmitriptan were pain-free compared to 19 percent of the placebo group.
Winner says that the adolescents who received the zolmitriptan experienced no serious side effects.
As a result of this study, Winner says he is quite comfortable about prescribing the adult medication to teens under certain conditions, including occasional use for those who report a headache once a week. He does not advocate its use every day.
Most doctors and patients are reluctant to use FDA-approved medications for conditions that have not been indicated by the agency's review process, called "off-label" prescribing, so Winner is hoping his research will encourage others to continue testing triptans for use in adolescents.
According to Alan Carver, an assistant professor of neurology at Mount Sinai School of Medicine in New York City, who welcomes the new research , the study is not the first of its kind.
He says that the American Academy of Neurology has issued guidelines on the use of triptans for teens, which include reports of small studies showing that sumatriptan nasal spray (Imitrex) was effective in reducing pain in adolescents and recommended its use for acute migraines in teens.
The study findings were presented at the American Headache Society's annual meeting in Philadelphia.
The study was funded by a grant from AstraZeneca, the maker of Zomig.
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