When Are OTC Analgesics Appropriate for Acute Migraine?

February 1, 2003
Seymour Diamond, MD

,
Richard Wenzel, PharmD

A 34-year-old woman complains of headaches that interfere with work. Her first headache episode, approximately 6 yearsearlier, was relatively mild. Initially, she experienced attacks only once every 3 to 4 months and managed them effectivelywith over-the-counter (OTC) agents. However, in the last 6 months the attacks have become more frequent-they occur atleast twice a month-and are so severe that she misses work.

THE CASE:


A 34-year-old woman complains of headaches that interfere with work. Her first headache episode, approximately 6 yearsearlier, was relatively mild. Initially, she experienced attacks only once every 3 to 4 months and managed them effectivelywith over-the-counter (OTC) agents. However, in the last 6 months the attacks have become more frequent--they occur atleast twice a month--and are so severe that she misses work.The patient takes acetaminophen, ibuprofen, or the combination of acetaminophen, aspirin, and caffeine for herheadaches. She has increased her use of OTC agents to at least 2 or 3 days a week in anticipation of attacks.Results of physical and other examinations are otherwise normal. A diagnosis of migraine without aura, accordingto International Headache Society criteria, is made.

THE DIALOGUE:
Primary care doctor:

My patient is frustrated that she canno longer control her headaches with OTC products. Hermissed days at work have motivated her to see me. Whatare your thoughts about the use of OTC analgesics in thissetting?

Headache specialist:

About 6 of every 10 migraineurs useonly OTC agents to treat their headaches.

1,2

Nearly 70% ofmen use OTCs exclusively, compared with 56% of women.This probably reflects the fact that women are more likelythan men to consult a physician. Yet OTC use is often ineffectiveand in many cases is associated with delay in seekingmedical attention. About 28 million Americans sufferfrom migraine, which means that a substantial number ofpeople are self-medicating with little or no benefit.

1

Doctor:

Do you think my patient would benefit from a differentOTC product?

Headache specialist:

I doubt if that would help. Two of theOTC agents she currently uses (ibuprofen and a combinationof acetaminophen, aspirin, and caffeine) have beenapproved by the FDA for the treatment of migraine buthave proved ineffective for her. Other nonprescriptiondrugs used to treat headache pain that are not specificallyFDA-approved for migraine include naproxen sodium andvarious caffeine-containing products.

2

However, becauseyour patient's headaches are severe enough that theycause her to miss work, other OTC agents are also unlikelyto be effective. I believe she requires a migraine-specificprescription agent.OTC migraine products have never been found effectivefor headaches that result in impairment. Persons withmigraine-related disability have been systematically excludedfrom OTC drug trials.

2-7

For example, among theexclusion criteria for the ibuprofen studies were a historyof severely incapacitating migraines (ie, more than 50% ofepisodes required bed rest or prevented performance ofdaily activities) and vomiting during more than 20% of migraineepisodes.

3

Other studies had similar, if not identical,exclusion criteria. Thus, the results of these OTCdrug studies are based on treatment of the minority of migrainepatients--those who experience mild, nondisablingattacks.Many migraineurs (53%) experience severe impairmentwith their attacks.

2

Severe disability is more commonin patients with a diagnosis of migraine than in thosewithout this diagnosis

(Table);

it results in absences fromwork, school, and family responsibilities, as well as reducedability to perform daily functions. Disability is normallywhat drives patients to seek medical help.Many migraineurs have disability, and most use OTCproducts exclusively

(Figure).

2

Thus, probably millionsof patients take drugs that do not work for them. Worse,rather than seeking medical consultation and the appropriateprescription, headache patients commonly escalatetheir OTC dosage and/or frequency in an effort toachieve relief, thus placing themselves at risk for medication-induced headaches.

8

Only when this approach fails isthe person motivated to seek help. This appears to be thecase with your patient.

Doctor:

Some of my patients with headache present withmore subtle impairment. They may complain that lifehas become more "stressful" or report vague symptomssuch as insomnia. I used to think these patients werejust depressed. It takes time to discover that a patient'sheadaches disrupt his or her ability to function.Recurrent "sinus" problems are another ambiguouscomplaint. Most of these patients clearly do not have signsof sinus infection (fever, purulent discharge, or positiveresults on radiography). I havelearned the hard way that such complaintsshould raise the suspicion ofmigraine.Once migraine has been diagnosed,how can I best determinewhether a migraine-specific prescriptionagent is warranted?

Headache specialist:

I recommendquantifying a patient's disability witha validated tool such as the MigraineDisability Assessment (MIDAS)Questionnaire or the Headache ImpactTest.

9-13

[

Editor's note:

TheMIDAS Questionnaire appears onpage 192.] Both of these instrumentsare quick and easy to use and canhelp you select appropriate therapy.They can also help chart the patient'simprovement with treatment. LowerMIDAS scores correlate with reduceddisability and less frequentuse of health-related resources.

14

Justas we measure changes in bloodpressure or cholesterol, we need tomeasure changes in headache-relateddisability to assess the effectivenessof our interventions.

Doctor:

What are the other benefits of using disability as akey differentiating tool?

Headache specialist:

Persons with nondisabling attacksmay be helped by OTC agents. A few patients can distinguisha simple tension-type headache from a migraineearly on in an attack. I recommend OTC products forthese patients' mild attacks. If they are unsure about thenature of an attack, I encourage prescription agent use.As with any acute medication--OTC or prescription--limitations on use need to be established. When patientsare taking medications for acute headache morethan 2 or 3 days a week, other treatment options--includingprophylactic drugs and nonpharmacologic therapies--need to be explored.

Doctor:

If OTC medications are not effective for disablingmigraine, why are they so widely advertised?

Headache specialist:

I don't have the answer. MigrainerelatedOTC advertisements are a disservice to patients.Such promotion can trivialize migraine and thus contributeto ineffective treatment.