OTC Analgesics

When Are OTC Analgesics Appropriate for Acute Migraine?


A 34-year-old woman complains of headaches that interfere with work. Her first headache episode, approximately 6 years earlier, was relatively mild. Initially, she experienced attacks only once every 3 to 4 months and managed them effectively with over-the-counter (OTC) agents. However, in the last 6 months the attacks have become more frequent—they occur at least 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 her headaches. 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, according to International Headache Society criteria, is made.
Primary care doctor: My patient is frustrated that she can no longer control her headaches with OTC products. Her missed days at work have motivated her to see me. What are your thoughts about the use of OTC analgesics in this setting?
Headache specialist: About 6 of every 10 migraineurs use only OTC agents to treat their headaches.1,2 Nearly 70% of men use OTCs exclusively, compared with 56% of women. This probably reflects the fact that women are more likely than men to consult a physician. Yet OTC use is often ineffective and in many cases is associated with delay in seeking medical attention. About 28 million Americans suffer from migraine, which means that a substantial number of people are self-medicating with little or no benefit.1
Doctor: Do you think my patient would benefit from a different OTC product?
Headache specialist: I doubt if that would help. Two of the OTC agents she currently uses (ibuprofen and a combination of acetaminophen, aspirin, and caffeine) have been approved by the FDA for the treatment of migraine but have proved ineffective for her. Other nonprescription drugs used to treat headache pain that are not specifically FDA-approved for migraine include naproxen sodium and various caffeine-containing products.2 However, because your patient’s headaches are severe enough that they cause her to miss work, other OTC agents are also unlikely to be effective. I believe she requires a migraine-specific prescription agent. OTC migraine products have never been found effective for headaches that result in impairment. Persons with migraine-related disability have been systematically excluded from OTC drug trials.2-7 For example, among the exclusion criteria for the ibuprofen studies were a history of severely incapacitating migraines (ie, more than 50% of episodes required bed rest or prevented performance of daily activities) and vomiting during more than 20% of migraine episodes.3 Other studies had similar, if not identical, exclusion criteria. Thus, the results of these OTC drug studies are based on treatment of the minority of migraine patients—those who experience mild, nondisabling attacks. Many migraineurs (53%) experience severe impairment with their attacks.2Severe disability is more common in patients with a diagnosis of migraine than in those without this diagnosis; it results in absences from work, school, and family responsibilities, as well as reduced ability to perform daily functions. Disability is normally what drives patients to seek medical help. Many migraineurs have disability, and most use OTC products exclusively.2 Thus, probably millions of patients take drugs that do not work for them. Worse, rather than seeking medical consultation and the appropriate prescription, headache patients commonly escalate their OTC dosage and/or frequency in an effort to achieve relief, thus placing themselves at risk for medication- induced headaches.8 Only when this approach fails is the person motivated to seek help. This appears to be the case with your patient.
Doctor: Some of my patients with headache present with more subtle impairment. They may complain that life has become more “stressful” or report vague symptoms such as insomnia. I used to think these patients were just depressed. It takes time to discover that a patient’s headaches disrupt his or her ability to function. Recurrent “sinus” problems are another ambiguous complaint. Most of these patients clearly do not have signs of sinus infection (fever, purulent discharge, or positive results on radiography). I have learned the hard way that such complaints should raise the suspicion of migraine. Once migraine has been diagnosed, how can I best determine whether a migraine-specific prescription agent is warranted?
Headache specialist: I recommend quantifying a patient’s disability with a validated tool such as the Migraine Disability Assessment (MIDAS) Questionnaire or the Headache Impact Test.9-13 Both of these instruments are quick and easy to use and can help you select appropriate therapy. They can also help chart the patient’s improvement with treatment. Lower MIDAS scores correlate with reduced disability and less frequent use of health-related resources.14 Just as we measure changes in blood pressure or cholesterol, we need to measure changes in headache-related disability to assess the effectiveness of our interventions.
Doctor: What are the other benefits of using disability as a key differentiating tool?
Headache specialist: Persons with nondisabling attacks may be helped by OTC agents. A few patients can distinguish a simple tension-type headache from a migraine early on in an attack. I recommend OTC products for these patients’ mild attacks. If they are unsure about the nature of an attack, I encourage prescription agent use. As with any acute medication—OTC or prescription— limitations on use need to be established. When patients are taking medications for acute headache more than 2 or 3 days a week, other treatment options—including prophylactic drugs and nonpharmacologic therapies— need to be explored.
Doctor: If OTC medications are not effective for disabling migraine, why are they so widely advertised?
Headache specialist: I don’t have the answer. Migrainerelated OTC advertisements are a disservice to patients. Such promotion can trivialize migraine and thus contribute to ineffective treatment.