WebMD Medical News
Louise Chang, MD
Sept. 17, 2012 -- The Excedrin recall in January was a big headache, and not just for its manufacturer. Since then, customers loyal to the brand have been searching high and low for the product -- and anxiously awaiting its return.
Now, there's light at the end of the tunnel. Excedrin Migraine is due back on store shelves by early October, says Milicent Brooks of Novartis, its producer. Other products involved in the recall will roll out after that.
That's not a moment too soon for headache sufferers like Katie Brooke, 25, a restaurant manager in Orlando. Like legions of other headache sufferers, she was dismayed to find the store shelves empty of the headache remedy when she needed to replenish her supply in February.
"Months went by, and I thought, 'Where is my Excedrin?'" she says.
Novartis had recalled it voluntarily, along with Bufferin, Gas-X, and No-Doz, because the products may have contained stray tablets from other Novartis products or from painkillers produced at the same plant. The recall followed a report from the FDA about production and other practices at the plant.
To cope with the Excedrin recall, some users have turned to buying it online from second-hand sources. This week, for instance, an independent seller on Amazon offered 100 tablets of Excedrin Migraine for $175.50, compared to a typical pre-recall cost of less than $10.
Brooke won't buy online, but instead has turned to another migraine remedy from the drugstore. She finds it does not work as well, even though it contains exactly the same ingredients. She supplements it with Mountain Dew, which is caffeinated.
Her new migraine medicine, from Walgreens, takes about 30 to 60 minutes to work, she says. "With Excedrin, it worked within 20 minutes."
Could Excedrin really be that much different than numerous other remedies, some with the exact same active ingredients in exactly the same dose?
WebMD turned to headache and pharmacy experts to find out.
"There is not really any reason to believe the formulation of the generic versions are any different than that of Excedrin Migraine," says Andrew Charles, MD, professor of neurology and director of the University of California at Los Angeles Headache Research and Treatment Program.
Many migraine formulas are identical, agrees Allen Vaida, PharmD, executive vice president of the Institute for Safe Medication Practices.
Excedrin Migraine's active ingredients include:
Walgreens' Migraine Relief has the exact same ingredients at exactly the same doses.
When looking at Excedrin Migraine and other versions of the same formula, ''we suspect the difference between them to be minimal," says Jason Rosenberg, MD, assistant professor of neurology at Johns Hopkins Medical Institutions and director of the Johns Hopkins Headache Center at Bayview.
If two medicines have the same active ingredients, they are what experts term ''bioequivalent." That means that the ''same amount of the same ingredients get into your blood stream at about the same time," Rosenberg says.
In individual people, he says, ''the drugs might be absorbed differently. But I would be skeptical that it would have much effect."
Keeping steady and specific blood levels is crucial for some drugs, Charles says. However, ''we wouldn't consider migraine or headache in general to be one of those conditions where blood levels [of the medication] would be a big issue."
So what's going on with the die-hard Excedrin users?
"There is a significant amount of placebo response and patient brand loyalty, based in part on their experience and also on marketing," Charles says.
"Part of the beneficial effect of the drug is the belief that it does work," Rosenberg says.
"The placebo effect is a real effect," Rosenberg says. It can explain as much as 25% to 50% of the benefit of a drug, he says.
He cites research in which less expensive drugs were found to have less of a placebo effect.
Researchers from Massachusetts Institute of Technology and Stanford gave 82 people placebo pills and told them they were for pain relief. Half were told the drugs cost $2.50 a pill; the other half were told the pills were 10 cents each.
The men and women were then given shocks to the wrists. Those taking the higher-price pills reported greater pain reduction.
What a doctor advises a headache patient to take matters, too, Rosenberg says.
If a doctor recommends a specific medicine, the patient's expectations of that drug may be high, he says.
It's not uncommon for patients to say one drug works better than another, even if the formulas are the same, Vaida says. "Someone gets used to a certain medicine," he says. "There is a psychological component to it."
"Patients do become quite attached to specific brands of medicine," Charles says. ''That's true not just of headache but for other sorts of conditions."
Although an over-the-counter medication may be viewed as benign by people, Charles says anyone who has a headache every day should see a doctor to rule out other causes. Overusing headache medicine is common, he says. It can make headaches more frequent.
People who overuse medicine for headaches and then go off it for a time often return to a pattern of occasional headaches rather than daily, he says.
In a 2009 National Health Interview Survey, more than 21% of women polled and 10% of men said they had a migraine or other severe headache in the past three months.
SOURCES:Andrew Charles, MD, professor of neurology and director of the University of California Los Angeles Headache Research and Treatment Program.Jason Rosenberg, MD, assistant professor of neurology at Johns Hopkins Medical Institutions and director of the Johns Hopkins Headache Center at Bayview.Katie Brooke, restaurant manager, Orlando.Allen Vaida, Pharm D, executive vice-president, Institute for Safe Medication Practices, Horsham, Pa.Milicent Brooks, spokesperson, Novartis Consumer Health Inc., Parsippany, N.J.CDC: Morbidity and Mortality Weekly Report, Dec. 3, 2010.Waber, R. Journal of the American Medical Association, March 5, 2008.
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