Migraine Meds Epidrin, Midrin Update 2/7/11

Teri Robert @trobert Health Guide
  • As promised, I want to update you on the situation surrounding the Migraine abortive Medication Midrin and equivalent medications including Epidrin and those simply labeled isometheptene mucate / dichloralphenazone / acetaminophen.


    As I reported to you earlier, Midrin and equivalent medications have been disappearing from pharmacies for some time now. At the bottom of this is the problem that these medications were introduced before the current FDA approval process, so they have not been approved by the FDA. You can find an explanation of this in Migraine and Midrin-Like Medications Update, 1/15/11.

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    On January 28, I reported to you that Excellium Pharmaceuticals was attempting to come to an agreement with the FDA that would allow them to continue making their Midrin equivalent, Epidrin. They were not able to formulate an agreement with the FDA and have decided not to file a New Drug Application (NDA) for Epidrin with the FDA. It's important to understand that to file an NDA, Excellium would have to conduct clinical trials as if Epidrin had never been made or sold before. Epidrin was a compound of three ingredients - isometheptene mucate, dichloralphenazone, and acetaminophen - so Excellium would have had to conduct trials on each of the components separately an on the compound of the three. This would have taken years and cost millions of dollars with no guarantee of FDA approval at the end of the road. Thus, Excellium has now ceased production of Epidrin, and they have no plans to seek approval or make Epidrin again in the future.


    Thanks to one of our community members, I have found that Prodrin is still being made and shipped by Gentex Pharma, LLC. There's no way of knowing if or when Prodrin will be discontinued, but as of now, it should be available.


    On a related note, I want to share some information Midrin and equivalents that some Migraine specialists have recently told me. It's been said that Midrin and its equivalents are the only abortive medications that are safe for people with a history of or risk factors for cardiovascular disease and events. Some Migraine specialists do not agree that these medications are safer than triptans or ergotamines. One of the concerns about triptans and ergotamines is that they constrict blood vessels, increasing cardiovascular risks. It's worth noting, therefore, that the isometheptene mucate in Midrin and its equivalents is also a vasoconstrictor. Thus, some Migraine specialists feel that Midrin and similar medications aren't any safer than triptans or ergotamines.


    For information about other treatment options, see Since Midrin and the generid form of Midrin have been discontinued, what drug can be used as a replacement?


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  • Last updated February 7, 2011.

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Published On: February 07, 2011