Migraine Headache Prophylaxis in Adolescents

Transcription

1 I Migraine Headache Prophylaxis in Adolescents It s estimated that up to 28 percent of adolescents between the ages of 15 and 19 (mostly females) are affected by migraine (Lewis, Yonker, Winner, & Sowell, 2005). Researchers have documented the association between migraine headaches and reduced quality of life, including missed school days and impaired academic functioning (Lipton & Bigal, 2005; Powers, Patten, Hommel, & Hershey, 2003, 2004). Due to Abstract Migraine headache is estimated to affect up to 28 percent of adolescents, most of whom are female. Chronic migraine in this population has been associated with reduced quality of life and academic disruption due to missed school days. Historically, migraine headache was treated episodically as it occurred. In March 2014 the U.S. Food and Drug Administration approved an existing medication, topiramate (Topamax ), for migraine prophylaxis in adolescents between the ages of 12 and 17. This is the first FDA approval of a drug for migraine prevention in this population. There are several possible adverse effects of taking topiramate, some potentially serious, so adequate education for adolescents and their families on all the potential benefits and risks is imperative. DOI: / X Keywords adolescents headache migraine prevention Topamax topiramate HEIDI COLLINS FANTASIA the prevalence of migraine in this age group and potential negative consequences, it s important to consider available options for treatment and prevention. Because the burden of frequent migraines can be significant, preventing debilitating headaches before they begin is an important component of treatment. Currently, episodic treatment of migraine includes a range of medications, Photo Jetta Productions / Photodisc Collection / thinkstockphotos.com , AWHONN

2 It s estimated that up to 28 percent of adolescents between the ages of 15 and 19 (mostly females) are affected by migraine (Lewis, Yonker, Winner, & Sowell, 2005). Researchers have documented the association between migraine headaches and reduced quality of life, including missed school days and impaired academic functioning (Lipton & Bigal, 2005; Powers, Patten, Hommel, & Hershey, 2003, 2004). Due to the prevalence of migraine in this age group and potential negative consequences, it s important to consider available options for treatment and prevention. Because the burden of frequent migraines can be significant, preventing debilitating headaches before they begin is an important component of treatment. Currently, episodic treatment of migraine includes a range of medications, including simple over-the-counter analgesics (acetaminophen, ibuprofen) and prescription medications such as serotonin agonists (amitryptiline) and beta-blockers (propranolol). Opiates are rarely used to treat migraine headache in the adolescent population (Sivaswamy & Pawlik, 2013). Although these medications can provide episodic pain relief, they are prescribed as rescue measures and don t prevent or lessen migraine occurrence. Although various pharmacologic and behavioral therapies exist to treat adolescent migraine, until recently there was no medication approved by the U.S. Food and Drug Administration (FDA) to prevent migraine headache in adolescents. In March 2014, the FDA approved the use of topiramate (Topamax ) for migraine prophylaxis among adolescents between the ages of 12 and 17 (FDA, 2014), making this the only FDAapproved medication for migraine prevention in the age group. Prior to FDA approval, efficacy and safety of topiramate had been established. In a randomized, double-blind, placebocontrolled trial, adolescents who received topiramate had a nearly 40 percent reduction in the monthly occurrence of migraine headache compared to those in the placebo group (Lewis et al., 2009). Mechanism of Action Topiramate is an antiepileptic drug that was first approved for the prevention of seizures in 1996 and received additional FDA approval for the prevention of migraines in adults in 2004 (FDA, Box 1. Titration Schedule for Migraine Prophylaxis for Adolescents Age 12 and Older* Week 1 Week 2 Week 3 Week 4 Morning (a.m.) None Evening (p.m.) *Suggested schedule, final dose and titration length dependent on patient tolerance and response to medication. Source: Janssen Pharmaceuticals, Inc. (2009). Because the burden of frequent migraines can be significant, preventing debilitating headaches before they begin is an important component of treatment 2014). The exact mechanism by which topiramate works to prevent migraine headache is not known, but seems to be related to alteration of biochemical processes and a reduction in neurologic hyperexcitability that can precede headache development in certain individuals (Carmona & Bruera, 2009; Janssen Pharmaceuticals, Inc., 2009; Rothrock, 2012). The medication is absorbed rapidly from the gastrointestinal tract regardless of timing with meals. Peak plasma concentrations can be reached within 2 hours of an oral dose (Carmona & Bruera, 2009; Janssen Pharmaceuticals, Inc., 2009). Dosage and Administration When used for migraine prophylaxis, the starting dose for adolescents 12 years of age and older is orally at bedtime for 1 week. Each subsequent week the dose is titrated up by 25 mg until either of two scenarios occurs: (1) the recommended daily dose of 100 mg in two divided doses is reached, or (2) the maximum tolerated daily dose is reached (Janssen Pharmaceuticals, Inc., 2009). See Box 1 for suggested titration schedule. The dosing guidelines are Rx Heidi Collins Fantasia, PhD, RN, WHNP-BC, is an assistant professor in the School of Nursing, College of Health Sciences at the University of Massachusetts in Lowell, MA, and a women s health nurse practitioner at Health Quarters in Beverly, MA. The author discloses that she is a member of the women s health advisory board for Actavis Pharma, for which she receives financial consideration. Address correspondence to: Heidi_Fantasia@uml.edu. October November 2014 Nursing for Women s Health 421

3 The exact mechanism by which topiramate works to prevent migraine headache is not known, but seems to be related to alteration of biochemical processes and a reduction in neurologic hyperexcitability that can precede headache development in certain individuals the same for migraine with and without aura. Topiramate is supplied as either whole tablets or Sprinkle Capsules that can be opened and mixed with a spoonful of soft food, which is an option for adolescents who have difficulty swallowing tablets (Janssen Pharmaceuticals, Inc., 2009). Adverse Effects As with all antiepileptic medications, topiramate has many potential side effects, some of which can be serious and life-threatening. Visual changes, including visual field deficits, acute myopia and secondary closed angle glaucoma have been reported in adults and pediatric patients taking topiramate, and usually manifest within 1 month of beginning treatment (Janssen Pharmaceuticals, Inc., 2009; Lewis et al., 2009). Metabolic acidosis, renal calculi and central nervous system effects of fatigue/ somnolence, paresthesia and difficulty with concentration or speech and language have been reported. An additional serious concern is the potential for suicidal behavior and ideation that has been observed in people taking antiepileptic medications, including topiramate (Janssen Pharmaceuticals, Inc., 2009; Lewis et al., 2009). These altered thoughts can be experienced as soon as within 1 week of starting topiramate; therefore, any new or worsening depression and mood changes should be carefully investigated. Pregnancy Implications Another adverse effect associated with topiramate has special implications for females. Topiramate is classified as a pregnancy category D medication because it s known to cause fetal harm when taken by women during pregnancy. Infants who have been exposed to topiramate in utero have an increased risk of oral clefts of the palate and/or mouth. While exact risks are not known, data from large pregnancy registries in the United States and United Kingdom suggest that infants exposed to topiramate in utero have a risk of oral cleft development that is two times greater than that of the general population (Janssen Pharmaceuticals, Inc., 2009; Rothrock, 2012). Women who become pregnant while taking topiramate should be encouraged to enroll in the North American Antiepileptic Drug Pregnancy Registry (Janssen Pharmaceutical, Inc., 2009; see Box 2). Topiramate is excreted into breast milk and infant plasma levels have been detected in offspring of mothers taking this medication. Because the effects on infants are Photo tetmc / thinkstockphotos.com 422 Nursing for Women s Health Volume 18 Issue 5

4 not known, women who are breastfeeding should not take topiramate (Janssen Pharmaceuticals, Inc., 2009). Drug Interactions One of the most significant potential drug interactions for adolescent women taking topiramate is the possibility of decreased effectiveness oral contraceptives. Ethinyl estradiol levels in combined oral contraceptive pills have been lowered when women have taken 200 mg or greater of daily topiramate when also combined with valproic acid (Janssen Pharmaceuticals, Inc., 2009). Although this decrease in estrogen levels has not been seen when taking topiramate alone, the possibility must still be considered, including an increased risk of breakthrough bleeding. know immediately and discuss tapering off the mediation. Antiepileptic drugs increase the risk of suicidal thoughts, behaviors and thoughts of self-harm, regardless of whether they are being taken for migraine prophylaxis or to treat epilepsy (Janssen Pharmaceuticals, Inc., 2009). These altered thoughts can occur among individuals with no previous mental health issues. A thorough health history, including assessment for depression and other mental health conditions, is necessary prior to beginning treatment. Adolescents for whom topiramate. Renal calculi have been reported in adult patients taking topiramate at a rate that ranges from two to four times higher than in those not taking topiramate (Janssen Pharmaceuticals, Inc., 2009). Calculi have also been reported in the pediatric population. Adequate hydration is important to reduce the risk of stone formation, and adolescents should be aware of their hydration status and educated that they may need to increase their fluid intake, even if they don t perceive themselves to be thirsty. Metabolic acidosis has also been reported, and this risk in- Nurses who work with adolescent women taking topiramate should assess and document mental health status at each follow-up visit Photo monkeybusinessimages / thinkstockphotos.com Nursing Practice Considerations There are multiple implications for nurses who work with adolescent women who are considering prophylactic treatment with topiramate for migraine headaches. Of significant importance is a discussion regarding sexual activity, risk of pregnancy and the potential fetal toxicity associated with topiramate. Adolescents who are sexually active must be counseled on available contraceptive methods, and those who are not sexually active must be aware of the need to use effective contraception during medication usage if they become sexually active during treatment. This will require a discussion of all available methods, including long-acting reversible contraception and progestinonly methods such as injectable depot medroxyprogesterone acetate and oral progesterone-only pills. This is important to review as women who have migraine headache with aura are not considered to be appropriate candidates for estrogen-containing contraception due to the increased risk of cerebral vascular events. Women who become pregnant while taking topiramate should let their health care provider topiramate is being considered, as well as their families, need to be educated about signs of depression and encouraged to report any changes in mood, behavior or thought processes that occur during treatment. Nurses who work with adolescent women taking topiramate should assess and document mental health status at each follow-up visit. Additional teaching involves nutrition and hydration while taking creases with ketogenic (high-fat) diets. Baseline electrolyte measurement (including bicarbonate level) is important for monitoring potential changes during treatment and will assist with decisions regarding medication dose, medication discontinuation or the addition of alkali treatment (Janssen Pharmaceuticals, Inc., 2009). Nurses should inform adolescents and their parents that weight loss is a possible side effect of topiramate, although no adolescents October November 2014 Nursing for Women s Health 423

5 Box 2. Antiepileptic Drug Pregnancy Registry Antiepileptic Drug Pregnancy Registry withdrew from clinical trials due to weight changes (Lewis et al., 2009). Topiramate has the potential to cause visual changes and various neurologic effects such as paresthesia, fatigue, somnolence and cognitive changes that can include difficulty with concentration, attention and language expression (Janssen Pharmaceuticals, Inc., 2009; Lewis et al., 2009). Adolescents and their parents need education as to how these side effects can impair safety. Obtaining a driver s license is often a milestone event during adolescence, and women in this age group who are taking topiramate need to understand how the medication could affect their ability to operate a motor vehicle. Taking other central nervous system depressants, including alcohol, with topiramate will potentiate fatigue and drowsiness. Alcohol experimentation during adolescence is common (Swendsen et al., 2012). A clear and direct conversation about the risks of alcohol experimentation is necessary and should be placed within an overall framework of health and safety teaching in this age group. Conclusion Topiramate is not a new drug, but the expanded use of this medication for migraine prophylaxis in adolescents age 12 and older represents a new option for migraine prevention, and not just treatment once migraine headache has occurred. Prophylactic treatment in the adolescent population requires individualized teaching. Adolescents can exhibit a wide range of developmental and emotional maturity, and education must be specific and tailored to their needs and developmental stage. Including parents in discussions of correct use, potential side effects and warning signs is important to increase medication safety and treatment efficacy. NWH References Carmona, S., & Bruera, O. (2009). Prophylactic treatment of migraine and migraine clinical variants with topiramate: An update. Therapeutics and Clinical Risk Management, 5, Janssen Pharmaceuticals, Inc. (2009). Highlights of prescribing information for Topamax. Titusville, NJ: Author. Retrieved from sites/default/files/topamax.pdf#zoom=100 Lewis, D., Winner, P., Saper, J., Ness, S., Polverejan, E., Wang, S., & Ford, L. (2009). Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of topiramate for migraine prevention in pediatric subjects 12 to 17 years of age. Pediatrics, 123(3), doi:10:1542/peds Lewis, D. W., Yonker, M., Winner, P., & Sowell, M. (2005). The treatment of pediatric migraine. Pediatric Annals, 34(6), Lipton, R. B., & Bigal, M. E. (2005). Migraine: Epidemiology, impact, and risk factors for progression. Headache, 45(Suppl. 1), S3 S13. doi: /j x Powers, S. W., Patten, S. R., Hommel, K. A., & Hershey, A. D. (2003). Quality of life in childhood migraines: Clinical impact and comparison to other chronic illnesses. Pediatrics, 112(1), e1 e5. Powers, S. W., Patten, S. R., Hommel, K. A., & Hershey, A. D. (2004). Quality of life in paediatric migraine: Characterization of age-related effects using PedsQL 4.0. Cephalalgia, 24(2), doi: /j x Rothrock, J. F. (2012). Topiramate for migraine prevention: An update. Headache, 52(5), doi: /j x Sivaswamy, L., & Pawlik, K. (2013). Migraine management among pediatricians: A questionnairebased survey. Clinical Pediatrics, 52, doi: / Swendsen, J., Burstein, M., Case, B., Conway, K. P., Dierker, L., He, J., & Merikangas, K. R. (2012). Use and abuse of alcohol and illicit drugs in U.S. adolescents: Results of the national comorbidity survey-adolescent supplement. Archives of General Psychiatry, 69(4), doi: / archgenpsychiatry U.S. Food and Drug Administration (FDA). (2014). FDA approves Topamax for migraine prevention in adolescents [News release]. Silver Spring, MD: Author. Retrieved from NewsEvents/Newsroom/PressAnnouncements/ ucm htm?source=govdelivery&utm_ medium= &utm_source=govdelivery 424 Nursing for Women s Health Volume 18 Issue 5