*** Drug Safety Alert *** May 6, 2013, the U.S. Food and Drug Administration (FDA) advised health care professionals and women that the anti-seizure medication valproate sodium and related products, valproic acid and divalproex sodium, are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches. Based on information from a recent study, there is evidence that these medications can cause decreased IQ scores in children whose mothers took them while pregnant. Stronger warnings about use during pregnancy will be added to the drug labels, and valproate’s pregnancy category for migraine use will be changed from "D" (the potential benefit of the drug in pregnant women may be acceptable despite its potential risks) to "X" (the risk of use in pregnant women clearly outweighs any possible benefit of the drug). Valproate products will remain in pregnancy category D for treating epilepsy and manic episodes associated with bipolar disorder. BACKGROUND: Valproate products are approved for the treatment of certain types of epilepsy, the treatment of manic episodes associated with bipolar disorder, and the prevention of migraine headaches. They are also used off-label (for uses not approved by FDA) for other conditions, particularly other psychiatric conditions. This alert is based on the final results of the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study showing that children exposed to valproate products while their mothers were pregnant had decreased IQs at age 6 compared to children exposed to other anti-epileptic drugs. For additional details, see the Drug Safety Communication Data Summary section. RECOMMENDATION: Valproate products should not be used in pregnant women for prevention of migraine headaches and should be used in pregnant women with epilepsy or bipolar disorder only if other treatments have failed to provide adequate symptom control or are otherwise unacceptable. Women who are pregnant and taking a valproate medication should not stop their medication but should talk to their health care professionals immediately. Stopping valproate treatment suddenly can cause serious and life-threatening medical problems to the woman or her baby. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report.htm Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 Read the complete MedWatch safety alert, including a link to the Drug Safety Communication at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350 868.htm. Health Care Guideline Diagnosis and Treatment of Headache How to Cite this Document Beithon J, Gallenberg M, Johnson K, Kildahl P, Krenik J, Liebow M, Linbo L, Myers C, Peterson S, Schmidt J, Swanson J. Institute for Clinical Systems Improvement. Diagnosis and Treatment of Headache. Updated January 2013. ICSI Members, Sponsors and organizations delivering care within Minnesota borders, may use ICSI documents in the following ways: • ICSI Health Care Guidelines and related products (hereinafter “Guidelines”) may be used and distributed by ICSI Member and Sponsor organizations as well as organizations delivering care within Minnesota borders. 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The Institute for Clinical Systems Improvement assumes no liability for any use, adaptations, revisions or modifications made to ICSI Health Care Guidelines by the user or others. www.icsi.org Copyright © 2013 by Institute for Clinical Systems Improvement Health Care Guideline: Diagnosis and Treatment of Headache Eleventh Edition Main Algorithm 1 January 2013 1 Diagnosis algorithm Migraine is the most • Evaluate type of headache common headache • Take a detailed history disorder seen by primary and assess functional care providers. impairment • Rule out causes for concern Text in blue in this algorithm • Consider secondary indicates a linked corresponding headache disorder annotation. • Refer to specialist when indicated 2 3 4 Migraine Treatment Tension-Type Headache Cluster Headache algorithm algorithm algorithm • Categorize and select • Establish diagnosis • Establish diagnosis treatment based on • Acute treatment • Acute treatment severity and functional • Prophylactic treatment • Prophylactic treatment impairment • Patient education and • Patient education and • Consider special lifestyle modifications lifestyle modifications treatment (including DHE) for status headache (See Dihydroergotamine Mesylate [DHE] algorithm) • Patient education and lifestyle modifications 5 Is patient a female whose headache may be no hormonally related? yes 6 7 8 Menstrual-Associated Perimenopausal or On Estrogen-Containing Migraine algorithm Menopausal Contraceptives or Migraine algorithm Considering Estrogen- Containing Contraceptives Migraine algorithm Diagnosis and treatment of headache is a complex issue necessitating the considerable 9 length and detail in this document. Migraine Prophylactic Treatment algorithm • Algorithms: Pages 1-10 • Annotations: Pages 18-45 Return to Table of Contents • Drug Tables: Pages 76-80 www.icsi.org Copyright © 2013 by Institute for Clinical Systems Improvement 1 Diagnosis and Treatment of Headache Eleventh Edition/January 2013 Diagnosis Algorithm 10 11 Patient presents with Text in blue in this algorithm Detailed History complaint of a • Characteristics of the indicates a linked corresponding headache headache annotation. • Assess functional impairment 11 • Past medical history Critical first steps: • Family history of migraines 12 • Detailed history • Current medications and Causes for concern: • Focused physical previous medications for • Subacute and/or examination headache (Rx and progressive headache over • Focused over-the-counter) months neurological • Social history • New or different headache examination • Review of systems - to rule • "Worst headache ever" out systemic illness • Any headache of maximum severity at onset 12 • Onset after the age of 50 13 years old Causes for yes Consider secondary • Symptoms of systemic concern? headache disorder illness • Seizures • Any neurological signs no 21 24 Specialty 14 yes Refer to headache consultation specialist indicated? Meets criteria for primary no no headache disorder? 2 5 22 Perform diagnostic Diagnosis of yes yes testing if indicated primary headache confirmed? no 23 26 Findings Determine secondary no consistent with yes secondary headache type headache? Out of guideline 15 Evaluate type of primary headache. Initiate patient education and lifestyle management 16 1 7 18 19 20 Migraine Tension-type Cluster (See Migraine (See Tension-Type (see Cluster Chronic daily Other headache Treatment Headache Headache headache algorithm) algorithm) algorithm) Sinus Headache 15 Migraine-associated symptoms are often misdiagnosed as "sinus headache" by patients and clinicians. Most headaches characterized as "sinus headaches" are migraines. The International Classifications of Headache Disorders (ICHD-II) defines sinus headache by purulent nasal discharge, pathologic sinus finding by imaging, simultaneous onset of headache and sinusitis, and headache localized to specific facial and cranial areas of the sinuses. Return to Table of Contents www.icsi.org Institute for Clinical Systems Improvement 2 Diagnosis and Treatment of Headache Eleventh Edition/January 2013 Migraine Treatment Algorithm 2 7 Patient meets criteria for migraine For information on adolescents The patient would enter this 28 (ages 12-17), refer to the "Special 29 algorithm from box 16 of the Is patient Circumstances" section. experiencing a no Return to Diagnosis Diagnosis algorithm. typical headache? algorithm yes Text in blue in this algorithm 3 0 Categorize according to peak severity based indicates a linked corresponding on functional impairment, duration of annotation. symptoms, and time to peak impairment 31 35 3 8 43 Status Severe Mild Moderate (> 72 hour duration) 39 32 36 44 Mild treatment:** Moderate Severe - APAP/ASA/ treatment:** - Prochlorperazine Adjunctive therapy Caffeine - DHE - Chlorpromazine - ASA - Ergotamine - DHE - Lidocaine nasal tartrate - Ketorolac IM - Magnesium - Midrin® - Lidocaine nasal 47 - NSAIDs - Midrin® and Sulfate IV 45 - 5 HT agonists others - 5 HT agonists