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.
- 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.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
51293-617: Isometheptene Mucate/Dichloralphenazone/Acetaminophen
42195-145: Isometheptene Mucate, Caffeine, and Acetaminophen
58716-937L Isometheptene Mucate, Caffeine, and Acetaminophen
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.
FDA. “FDA Notification Regarding Isometheptene-Containing Drug Products.” June 18, 2018.
Interview with David B. Watson, MD. August 22, 2018.