Migraine and Midrin-Like Medications Update, 1/15/11

Patient Expert

For the latest update on this situation, see Migraine Meds Epidrin, Midrin Update 1/28/11.

The Migraine medication Midrin has been permanently discontinued, and we've been looking for news regarding other medications like it.

In investigating the problem, I contacted the FDA. They explained that Midrin was introduced before the current drug approval process was put into place. So other medications like it aren't really generics; they're other medications with the same ingredients. The issue with all of these medications is that they have never been approved by the FDA. It's rather confusing. Here's how the FDA explains unapproved drugs on the market:

What are unapproved drugs and why are they on the market?
The original Federal Food and Drugs Act of 1906 brought drug regulation under federal law. That Act prohibited the sale of adulterated or misbranded drugs, but did not require that drugs be approved by FDA. In 1938, Congress required that new drugs be approved for safety. In 1962, Congress amended the 1938 law to require manufacturers to show that their drug products were effective, as well as safe. As a result, all drugs approved between 1938 and 1962 had to be reviewed again for effectiveness. To be consistent with current regulations and to ensure that all drugs have been shown to be safe and effective, all new drugs are required to have an approved application for continued marketing.

Many healthcare providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs' labels do not disclose that they lack FDA approval. In addition, since many unapproved drugs are marketed without brand names and have been available for many years, it is often assumed that these unapproved drugs are generic drugs. This is not correct. Generic drugs have been evaluated and approved by FDA to demonstrate bioequivalence to a brand name reference drug. Healthcare professionals and consumers can be assured that FDA-approved generic drug products have met the same quality, strength, purity and stability as brand name drugs. Additionally, the generic manufacturing, packaging, and testing sites must meet the same quality standards as those of brand name drugs. Unapproved drug products have not been evaluated and approved by FDA. Unapproved drugs are not generic medications, and neither their safety nor their efficacy can be assured.

What it all boils down to is that any pharmaceutical company that wants to manufacture a isometheptene mucate / dichloralphenazone / acetaminophen drug (the ingredients in Midrin) must invest millions of dollars to prove the efficacy and safety of the drug and submit an application for approval to the FDA.

The Good News The good news in all of this is that Excellium Pharmaceuticals, the company that has been manufacturing Epidrin, is in the process of doing just that. Until they've submitted their application and it's been approved by the FDA, they will not be making Epidrin or shipping any to suppliers. Hopefully, their application will be approved by early spring.

Emailing the FDA? Several people have written the FDA about these medications. I did, and got a reply. You can read that reply in _Midrin: What's Going On? _ From what I can tell, continuing to write the FDA would be an exercise in futility because they cannot circumvent the law - the Food, Drug and Cosmetic Act.

Now What? Some people are still finding pharmacies that have some of these medications in stock. You can call pharmacies in your area to see if they have any of them and, if so, which one, then ask your doctor for a prescription for that particular medication.

Hopefully, Epidrin will make its way through the approval process smoothly, and soon.

I'm going to continue contacting manufacturers of other isometheptene mucate / dichloralphenazone / acetaminophen medications to see if they're applying for FDA approval and will post updates as I get more information.

For information about other Migraine abortive medications, see _Since Midrin and the generic form of Midrin has been discontinued, what drug can be used as a replacement?_I realize that some people can't take other abortives, but if you haven't discussed these with your doctor, that post gives you some information to begin your discussion.Stay tuned!Live well,



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