What Your Doctor May Not Be Telling You About Treximet
Many people suffer from migraine headaches, an excruciating condition that can make the ordinary demands of life impossible. There are many medications available to treat migraines. If you or your doctor are considering Treximet, there are things you should know about this drug before you decide to take it.
What is Treximet?
Treximet is a medication for the treatment of migraine attacks in adults. It is made and marketed by GlaxoSmithKline in the United States.1
Does Treximet work? Are advertising claims about it accurate?
GlaxoSmithKline ran a series of five internet banner ads for Treximet that failed to communicate required warnings about the safety of Treximet. Claims about the effectiveness of Treximet were prominent in these ads with large print and graphics cycling through the banner: a woman holding her head in her hands with large text claiming, “My migraines are so excruciating…” and “Ask your doctor if new Treximet is right for you,” above an image of the same woman smiling.
The FDA declared that the “overall effect of this presentation is to obfuscate the communication of important risk information, misleadingly suggesting that TREXIMET is safer than has been demonstrated by substantial evidence or clinical experience.”2
The FDA’s letter noted that the misleading banner ad included a claim that Treximet was superior to relieving migraines than the most prominent ingredient in Imitrex. The FDA acknowledged that this was true and pointed out that the ad failed to state that Treximet includes this same ingredient, combined with another drug.2 Imitrex is also made and marketed by GlaxoSmithKline,3 the makers of Treximet.
What should I ask my doctor about before I decide to take Treximet?
For one thing, you’ll have to be very careful not to use too much of it. The FDA has recently warned consumers that overuse of this medication can result in worse and/or more frequent headaches.4
In addition, the side effects reported from Treximet include some that are quite serious, even life-threathening. What are they?
You should find out all the information that you can about Treximet before you ask your doctor to prescribe it for you.
What if I’m already using Treximet?
Talk to your doctor if you are concerned about Treximet. Your doctor can help you find alternatives that may be safer.
Learn everything that you can about Treximet before you start taking it.
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1 GlaxoSmithKline, http://www.treximet.com/about/migraine-pain-relief.html
2 Food and Drug Administration Division of Drug Marketing, Advertising, and Communications, Warning Letter (9 March 2009), http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM165993.pdf
3 http://us.gsk.com/products/assets/us_imitrex_tablets.pdf
4 Food and Drug Administration, “Safety, Treximet,” (November 2011) http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm283116.htm