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Midrin and Other Discontinued Migraine Medications

Now What Do We Do?

   

Midrin, is a unique medication that can be used as a Migraine abortive or for tension-type headaches. It's a compound medication consisting of three ingredients - isometheptene mucate, dichloralphenazone, and acetaminophen. The isometheptene mucate helps reverse the vasodilation that sometimes occurs during a Migraine. Dichloralphenazone is a sedative, and acetaminophen is a simple analgesic.

Midrin has been a problem to get for some time now. There was a shortage of one of the ingredients in 2007. That was followed by some kind of manufacturing issues the manufacturer (Caraco) had a bit later. Finally, Caraco permanently discontinued Midrin. Tracing other medications with the same ingredients has been difficult. For some time, Epidrin, Duradin, and MigraTen (all with the same ingredients as Midrin) were available. Then patients had problems finding a pharmacy that could get those, but a "generic" isometheptene mucate / dichloralphenazone /acetaminophen was available.

Now, most (if not all) of those products have disappeared from pharmacies. To understand this better, we need to know that Midrin was first made and marketed before the current FDA drug approval process was in place. It was never reviewed by the FDA for efficacy and safety. Nor were any of the other similar products. And that's where the problem lies.

I discovered this issue with FDA approval when I emailed the FDA to ask why there were so many problems getting this medication. They replied:

Dear Teri,

Thank you for writing to the Division of Drug Information in the FDA's Center for Drug Evaluation and Research.

I believe most, if not all, manufacturers have ceased to make Midrin and its 'generic' versions. FDA has not yet asked manufacturers to discontinue manufacturing. However, please understand that Midrin has never been approved by FDA, and companies may have ceased manufacturing to comply with FDA regulations. You may find FDA enforcement actions against unapproved products at: http://tinyurl.com/yapmz9c.

Midrin is not FDA approved, but is on the Drug Efficacy Study Implementation (DESI) list. Since there is no approved application for Midrin, there are no approved generics for this product either. The products you are referring to are not generics, but rather other products that contain the same ingredients as Midrin.

The following is a brief general history, relevant to Midrin:

In 1962, Congress amended the 1938 Food, Drug and Cosmetic Act to give the FDA the authority to regulate medicines on the basis of efficacy in addition to safety. That is, the amendment required manufacturers to show that their drug products were effective, as well as meeting the requirement of the earlier Act, that the products must be safe. As a result of the 1962 amendment, all the drugs approved under New Drug Applications (NDAs) between 1938 and 1962 had to be reviewed again for efficacy. Furthermore, for every drug initially sold between 1938 and 1962 with approval by FDA, five others were sold without FDA approval. Many of these drugs were chemically identical copies of previously approved drugs, and hence were known as "me-too" drugs. Many others were combinations of approved ingredients. FDA decided that the efficacy study, to be fair and to accomplish its purpose of improving therapeutics in the United States, had to apply as well to these non approved drugs. Because the resources of the FDA were too limited to do this, the agency asked the National Academy of Sciences/National Research Council (NAS/NRC) to assist in the review effort. The NAS/NRC chose 30 panels, each composed of six experts, to conduct the review of various categories of drugs. The manufacturers of drugs with NDAs that had been submitted between 1938 and 1962 were asked to submit to the FDA their evidence that the drug was effective. The NAS/NRC panels then reviewed the data. In late 1967, the panels began submitting their reports to the FDA. The FDA formed a task force to implement the recommendations in the reports. This was the Drug Efficacy Study Implementation (DESI) task force. DESI products can continue to be marketed until a final determination is made.

Best regards,
Drug Information RL
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration

Midrin isn't the only Migraine medication affected by FDA efforts to put all medications on the market through the stringencies of the current FDA approval process. In 2007, many ergotamine medications were ordered pulled from the market, also because they hadn't gong through the FDA approval process and there was inadequate efficacy and safety data. Some ergotamine abortive medications have gone through the process and were not affected by this order. They include Migranal Nasal Spray, D.H.E. 45, and Cafergot. If you want to know what medications are approved and available, go to Drugs@FDA and enter ergotamine in the search box.

So, what's a Migraineur to do?

For those who have a history of or risk factors for stroke and other cardiovascular issues, this presents quite a problem. Midrin was the one Migraine abortive that wasn't contraindicated for them. I can only suggest that you have a conversation with your doctor about this. Some doctors will prescribe triptans for some of these patients, depending on their situation, if they feel that the Migraine itself presents as much risk as the medications.

To talk with your doctor, it would be helpful to know what Migraine abortive medications have been FDA approved and are currently available:

Triptans:

  • sumatriptan: available in generic and brand names Imitrex / Imigran; needle free sumatriptan injection available under the brand name Sumavel DosePro. Also available with sumatriptan and naproxen sodium in one tablet, brand name Treximet. Sumatriptan nasal spray available under brand name Imitrex / Imigran.
  • naramig: available in generic and brand names Amerge / Naramig. Tablets only.
  • rizatriptan: brand name Maxalt. Regular tablets and tablets that melt on tongue.
  • zolmitriptan: brand name Zomig. Regular tablets, nasal spray, and tablets that melt on tongue.
  • eletriptan: brand name Relpax.
  • frovatriptan: brand name Frova.
  • almotriptan: brand name Axert. This is the only triptan FDA approved for adolescents ages 12 to 17 years.

Ergotamines:

  • D.H.E. 45 injectable. Can be injected subcutaneously by patient at home. Also used in hospital and doctor's offices in IV injections and IV infusions.
  • Migranal Nasal Spray
  • Ergomar sublingual ergotamine tartrate tablets
  • Cafergot ergotamine and caffeine tablets. Discontinued by all manufacturers but Sandoz as of this date.
  • ergotamine tartrate and caffeine tablets (same as Cafergot) manufactured by West Ward and Mikart as of this date
  • Migergot Suppository (same ingredients as Cafergot). Manufactured by G and W Labs as of this date.
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Summary and comments:

The loss of Midrin as a treatment option isn't good news for us. The likelihood of any company investing the time and research dollars necessary to apply to the FDA for a drug equivalent to Midrin is slim. Yes, many people are still using it, but far fewer than before the triptans were developed, and triptan usages is up. The cost of triptans is down since two of them are now available as generics.

Some people have been under the impression that the 2007 issue with ergotamine abortives resulted in all of them being removed from the market. As you can see above, this is not the case.

Researchers are working to develop more Migraine abortive medications. In their research, they're working to find medications that won't present dangers to patients with history of or risk factors for stroke and other cardiovascular events. That doesn't help us today, but it does give me hope for the future.
 

____________
Resources:

Email conversation with Drug Information RL, Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration. December, 2010.

FDA. "Unapproved Drugs: Enforcement Actions." October 29, 2010.
   

Medical review by John Claude Krusz, PhD, MD

 

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Teri Robert, 2010. Last updated December 15, 2010.

 

 

 
 
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Anyone interested in the concerns or patients with these disorders is welcome to join.

The AHMA exists to EASE the burden of Migraine and other headache disorders through Education, Awareness, Support, and Engagement.

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