Topiramate for Chronic Migraine Too?
Although the FDA approval and prevention guidelines only cover episodic migraine, some studies suggest topiramate could also work in chronic migraine( or migraine that occurs 15 or more times per month).
Currently, onabotulinumtoxin A( Botox ®) is the only FDA-approved treatment for chronic migraine( although it is considered ineffective in the prevention of episodic migraine). 16 In one 2011 study, 59 chronic migraineurs were divided into two groups: one that received topiramate and one that received onabotulinumtoxin A. After four weeks of treatment, both groups took a Physician Global Assessment that measured improvement in chronic migraine. Of the topiramate group, 74 percent had improved; of the onabotulinumtoxin A group, 60.7 percent had improved. By week 12, 70.8 percent of the topiramate group had improved and 79.2 percent of the onabotulinumtoxin A group had improved. Ultimately, the treatments showed near-equal efficacy. 17
that women taking topiramate during the first trimester were more likely to give birth to infants with oral clefts. Specifically, the prevalence of oral clefts was 1.4 percent in topiramate-exposed patients, compared to 0.38-0.55 percent in infants exposed to other anti-epileptic drugs and 0.07 percent in infants who weren’ t exposed to any antiepileptic drug. 12
Due to these findings, the FDA recommends pregnant women not be prescribed the drug, except under dire circumstances. The FDA has also dropped the drug’ s pregnancy category rating from Category C( which means the risk of the drug to a baby is unknown) to Category D( which means there is evidence of fetal risk). 13
Other studies do not support the FDA’ s conclusion. For example, a 2012 study, which was published in the journal Headache( Mark W. Green, MD, FAAP, was the lead author), found little or no increase in risk from topiramate compared to other anti-epileptic drugs. The study followed insurance claims related to 4,485 infants born from mothers exposed to topiramate( 870 infants) and other anti-epileptic drugs( 3,615 infants) during the first trimester of pregnancy. The study found little or no increase in risk from topiramate compared to other anti-epileptic drugs. Comparatively, in the topiramate group, oral clefts occurred in 0.23 percent of births. Among those exposed to other anti-seizure medications, the birth defect occurred in 0.17 percent of births. 14
“ Ultimately physicians need to weigh the risks and benefits accurately in cases in which migraine control is necessary,” Dr. Green says.
CASE BY CASE
While no drug is a cure-all and no one medication will work for every migraineur, a better understanding of the benefits and risks of preventive medications could help headache specialists and migraineurs to determine the best possible treatment plan.
“ The 2012 prevention guidelines are an important starting point to understand the need and scope of migraine therapies for prevention,” Dr. Cady says.“ Beyond this starting point is the need for clinicians and patients to form an ongoing collaborative partnership that is outcome-based and directed to the individual needs of the patient.”
This partnership, coupled with research into a drug’ s efficacy and a review of the patient’ s medical history, is a necessary step in understanding and treating migraine and other headache conditions. If you are searching for a headache specialist, visit the National Headache Foundation’ s website at www. headaches. org or call 888-NHF-5552 for help. HW
12. FDA.“ Topamax( topiramate): Label Change – Risk for Development of Cleft Lip and / or Clef Palate in Newborns.” www. fda. gov / Safety / MedWatch / SafetyInformation / SafetyAlertsforHumanMedicalProducts / ucm245777. htm
13. FDA.“ FDA Drug Safety Communication: Risk of Oral Clefts in Children Born to Mothers Taking Topamax( topiramate).” www. fda. gov / Drugs / DrugSafety / ucm245085. htm 14. Green et al.“ Utilization of Topiramate During Pregnancy and Risk of Birth Defects.” Headache. 2012; 52( 7): 1070-1084. 15. National Headache Foundation.“ Largest Study of Migraine Sufferers Reveals Preventive Therapies Are Underused.” Head Lines.
Sept./ Oct. 2005. 16. Mathew et al.“ A Double-blind Comparison of Onabotulinumtoxina( BOTOX) and Topiramate( TOPAMAX) for the Prophylactic
Treatment of Chronic Migraine: A Pilot Study.” Headache. 2009; 49( 10): 1466-1478. 17. Cady et al.“ A Multi-center Double-blind Pilot Comparison of Onabotulinumtoxin A and Topiramate for the Prophylactic
Treatment of Chronic Migraine.” Headache. 2011; 51( 1): 21-32. www. headaches. org | National Headache Foundation 35