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Excedrin: Headache for aspirin-sensitive patients?


From the July 30,1997 Issue

PROBLEM:An 18-year-old female was admitted to the hospital with an anaphylactic reaction to aspirin. She required intubation and treatment with epinephrine, methylprednisolone and diphenhydramine. She was resuscitated and admitted to the respiratory ICU where she eventually recovered. The patient knew she was allergic to aspirin but she was unaware that it was in the Excedrin® Extra Strength tablets she took for her headache. Although the product does list aspirin as an ingredient on the carton label and bottle itself, and does warn allergic patients not to take it, the word "aspirin" appears below the brand name in very small print which may not be easily seen by people in a hurry or those with poor eyesight.

Excedrin Label

Figure 1. In proportion to brand name, aspirin content on label is not visible in this scaled-down scan. "Acetaminophen, aspirin, and caffeine" is listed between "Excedrin" and bar labeled "EXTRA STRENGTH."

SAFE PRACTICE RECOMMENDATION:: Based on new data proving effectiveness of the product, an FDA advisory panel recently recommended approval of Excedrin Extra Strength for treatment of migraines in people 18 years and older. If this is approved, it would become the first OTC migraine remedy and will probably become widely used by many of the estimated 23 million people in the US who suffer this condition. Patients must be aware that the product contains aspirin. Patient education will help, but improved labeling and label warnings would facilitate this awareness.

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