Since 2007, I’ve been following and informing others regarding the ongoing saga of the abortive medication Midrin and equivalents for Migraine treatment. In 2007, Midrin became unavailable for a time due to a shortage of one of the ingredients. When the shortage was resolved, Caraco (the manufacturer) began making and shipping it again. Later on, Caraco ran into some issues with the FDA over manufacturing issues. In the end, Caraco permanently discontinued manufacturing brand name Midrin.
Brand name Midrin, which was prescribed for tension-type Headache and Migraine, contained:
- acetaminophen, 325 mg: an analgesic
- isometheptene mucate, 65 mg: a vasoconstrictor that works to constrict dilated cranial and cerebral blood vessels
- dichloralphenazone, 100 mg: a mild sedative
Prodrin was a similar medication that contained two of the three ingredients that were in Midrin, plus caffeine:
- acetaminophen, 325 mg
- isometheptene mucate, 65 mg
- caffeine, 20 mg
For some time, a medication equivalent to Midrin was available from Macoven Pharmaceuticals in Magnolia, Texas. The label on the prescription bottle for this product was generally marked, “Isometh/Dich/Apap.”
Now, the FDA has issued a notice that puts an end to the distribution of Midrin and equivalents for Migraine.
[pdf-embedder url=”https://migrainewarriors.org/wp-content/uploads/2018/08/Lsometheptene-letter-to-firms-letterhead.pdf” title=”Lsometheptene letter to firms letterhead”]
Unapproved Isometheptene Mucate Drug Products and NDCs
71186-005: Isometheptene Mucate, Dichloralphenazone, and Acetaminophen
35573-310: Isometheptene Mucate, Caffeine, and Acetaminophen
35573-311: Isometheptene Mucate, Dichloralphenazone, and Acetaminophen
44183-440: Isometheptene Mucate, Dichloralphenazone, and Acetaminophen
44183-442: Nodolor
51293-617: Isometheptene Mucate/Dichloralphenazone/Acetaminophen
42195-145: Isometheptene Mucate, Caffeine, and Acetaminophen
15014-145: Prodrin
58657-401: Isometheptene-Dichloral-APAP
42291-344: Isometheptene-Dichloral-APAP
58716-937L Isometheptene Mucate, Caffeine, and Acetaminophen
Expert comment
Dr. David Watson, who is a UCNS certified Migraine specialist, director of the Headache Center and chairman of the Department of Neurology at West Virginia University, and the chair of our medical advisory board, commented:
“People with migraine have long struggled with limited treatment options, and so it is always concerning when one of those options disappears. Midrin and the equivalents were not the option of choice for most patients, but remained a useful tool for some with Migraine disease. However, I respect the FDA’s concerns of lack of evidence of benefit as well. In reality, what this challenge proves is that people with Migraine deserve better than decades-old unproven medication options and that the NIH needs to aggressively support the discovery and development of new therapeutics in Migraine and other Headache disorders.”
Comments and implications for patients
Midrin and equivalents for Migraine have been standards for years now. The FDA issue stems from Midrin having been developed before the current FDA drug approval process and the failure of pharmaceutical companies producing both brand name Midrin and the equivalents to perform clinical trials to prove their efficacy.
Some people have thought that Midrin and equivalents were safe for people for whom triptans and ergotamines were contraindicated due to history of cardiovascular issues. There has not, however, been a consensus about this in the “Headache medicine” field because isometheptene mucate has vasoconstrictor properties.
The bottom line here is that patients who have been using Midrin and equivalents for Migraine should talk with their doctors about alternatives since Midrin and equivalents will no longer be available.
Source:
FDA. “FDA Notification Regarding Isometheptene-Containing Drug Products.” June 18, 2018.
Interview with David B. Watson, MD. August 22, 2018.
Find a local compounding pharmacy asap! I had 12 pills left and thought I was doomed in the next month or two, but my doctor prescribed it to a compounding pharmacy. So relieved!
Hi Sarah! Could you please let me know where you had it compounded?? I can call them and see if they mail order if its out of my area. thanks in advance!!!
Roger, Please tell us where
Please, where where and how did you have it compounded?
Where do you get it compounded? This is the only drug that has ever held my husband’s migraines.
Very upset about this. This med was the only med I found to work. I’ve tried triptand and it about killed me. Sent me into hypertensive crisis and hospitalized for a week. Never even had high blood pressure. Tried the 3 combo pills; verapmil topimate and citrolapam. That made me feel numb and no sexual drive. Hope a manufacturing pharm company will pay to have it tested for fda approval.
One of the ingredients in Midrin is a vasodilator. There are newer medications in development that do not affect the cardiovascular system. It is probable that companies knew this and chose not to have it tested in lieu of newer, even safer options. Keep an eye out for Lasmiditan (a triptan that doesn’t cause cardiovascular changes) and ubrogepant (a oral CGRP inhibitor made for abortive use). Both should come to market very soon.
This is ridiculous. I was stunned when I went to pick up my refill today. I’m lucky my migraines are much less severe and frequent since I had a total hysterectomy several years ago. I usually get them now with some changes in air pressure and super hot days. Unfortunately, Midrin/generic was the only thing that worked for me. I went through hell the first time it became unavailable. I understand that it’s the FDA’s responsibility to keep us safe, but this has always struck me as a way to force patients to use the newer, more expensive medications. Though the Midrin equivalent wasn’t cheap either. Medicare stopped covering it years ago after the FDA removed its approval.
Roger, where did you have it compounded?
Has anyone tried something else similar to Midrin & it works? I can’t take triptans due to elevated blood pressure & am totally freaked out by the thought of getting a bad migraine without these pills. Help!?
Hi, Heidi,
There’s nothing similar to Midrin left on the market. The FDA order applied to all of the Midrin equivalent medications. The only other true abortives for home use are the triptans and ergotamines. The ergotamines have a high blood pressure warning as well. However, when blood pressure is kept under control with medications, many patients are able to use triptans or ergotamines. Actually, if Midrin had ever gone through the clinical trials, it might well have had a blood pressure warning to since it contained an ingredient that constricted blood vessels.
Keep your eyes open for new acute medications in development – the ditans and the gepants. It’s looking as if they may not have that kind of warning, and the first of them should be approved relatively soon.
Teri Robert
I have used this drug for over 50 years to prevent my migraines. I take it when I get the visual aura, and the headache does not occur. Without this drug, I am now doomed to suffer excruciating headaches for the rest of my life. I am in a panic. I hope something happens to fix this situation. I think the FDA is treating it like a painkiller. It is not a painkiller. It will not help the pain of a migraine once it occurs. It is for use only during the aura phase and it works to prevent the headache. I don’t know what I’m going to do
Gerri,
Please note that Midrin was not a preventive. It was a Migraine abortive. If you took it during aura, and didn’t get the headache phase, that’s because it aborted the Migraine attack during the aura phase; it didn’t prevent it. For some people, it did work when taken during the headache phase.
It’s not that the FDA is treating it like a painkiller. The problem is quite simple – none of the companies producing Midrin or its equivalents ever did the clinical trials to prove its efficacy, even though they had many years to do so.
Have you tried the triptans or ergotamines?
Teri Robert
This makes me want to break down and cry. I keep getting calls from the pharmacy saying that it’s back ordered it’s back ordered.
I assume this means we won’t even be able to have it specially compounded? Is that correct?
We are assuming this is true. If we learn differently, we’ll update our information.
I recently had it compounded. Thank God!