Read the latest update on Midrin here: Midrin-October 2011 Update
When I last blogged about the situation with Midrin and equivalent Migraine abortive medications, I promised to post an update when I had more information. I’m sorry to say that the newest information I have is not encouraging.
As I told you previously, Excellium Pharmaceuticals had been attempting to come to an agreement with the FDA that would let them continue producing their Midrin equivalent, Epidrin.
I learned yesterday, that no agreement could be reached. The only option left to Excellium was to file a New Drug Application (NDA) with the FDA. Filing an NDA for a compound like Epidrin, which contains three components – isometheptene mucate, dichloralphenazone, and acetaminophen – is very complex, time consuming, and expensive because clinical trials must be conducted to establish the safety and efficacy of each of the components separately, then the compounded medication. To file an NDA for Epidrin would have taken two or three years and cost millions of dollars. Excellium will not be pursuing this.
At this time, the closest thing I’ve been able to find to a Midrin equivalent that is still being made and shipped; Prodrin, made by Gentex Pharma, LLC. Like Midrin and its equivalents, it contains isometheptene mucate and acetamiophen. The difference is that it does not contain the dichloralphenazone (a sedative) that’s in Midrin, and it does contain caffeine. If you’re trying to locate a Midrin equivalent medication, ask your pharmacist to look for a supplier who distributes Gentex products.
There is another issue related to Midrin and these other medications containing isometheptene mucate, dichloralphenazone, and acetaminophen that I’d like to bring to your attention. Many people have told me that these medications are their only option for Migraine abortive medications because the triptans (Imitrex, Maxalt, Zomig, etc.) and ergotamines (D.H.E. 45, Cafergot, and Migranal) are contraindicated for people with a history of or high risk factors for cardiovascular disease. The main reason that the triptans and ergotamines are contraindicated is that one of their actions is vasoconstriction (constriction of blood vessels). Thus, it should be noted that the isometheptene mucate in Midrin and its equivalents is a vasoconstrictor. Some of the Migraine specialists with whom I’ve discussed this issue have told me that they do not consider the Midrin medications to be safer than triptans and ergotamines. The Midrin medications have never had any warning about this in their prescribing information. That may be because they have never gone through the current FDA drug approval process. I wanted to bring this to your attention so you can discuss it with your doctor if you want to.
For the background on why Midrin and equivalent medications are being removed from the market see Looking for Midrin Equivalents for Your Migraines?
You can read the latest update on Midrin here: Midrin-October 2011 Update