Attention headache patients! Midrin® is no longer available commercially, but the therapy you have come to trust can be prepared from scratch – by a pharmacist
Midrin® is a multiple ingredient medication typically prescribed for use in patients suffering from tension and migraine headaches.
The Food and Drug Administration (FDA) notified manufacturers and labelers to stop distributing drug products that contain isometheptene mucate, one of the active ingredients found in Midrin®. Isometheptene mucate was originally approved for safety in 1948 before the current FDA drug approval process. For this reason, the FDA considers isometheptene-containing products unapproved new drugs, requiring pharmaceutical companies to submit a new drug application and perform clinical trials proving effectiveness before these products can be manufactured again.
As of January 1, 2018, all companies producing isometheptene-containing drugs have agreed to cease distribution.
Midrin® is composed of acetaminophen, isometheptene mucate, and dichloralphenazone. Acetaminophen acts as a pain reliever by raising the body’s threshold to painful stimuli. Isometheptene mucate constricts certain blood vessels to reduce stimuli leading to vascular headaches. Dichloralphenazone is a mild sedative that helps reduce a patient’s emotional response to painful stimuli. Another commercial product, Prodrin®, which has also been discontinued, is a similar medication that contains two of the three ingredients found in Midrin®, plus caffeine.
Following various shortages and the eventual discontinuation of products like Midrin® and Prodrin®, patients have been forced to find new therapies to manage their headaches. Patients using Midrin® for several years to successfully manage their migraine episodes may experience a less than satisfactory response to alternative therapy. What can these patients do?
Fortunately, a pharmacist skilled in the science and art of compounding can prepare therapy containing the same active ingredients found in the commercially discontinued Midrin® and Prodrin® capsules.
A medication prescribed by a doctor for a specific patient is exempt from the new drug application process if certain criteria are met. The formulation prepared by the pharmacist must not contain ingredients that were discontinued due to safety reasons or appear on an FDA published “Do Not Compound List”. The active ingredients for the formulation must either be found in an already FDA approved drug product, a published positive formulary list, or have a United States Pharmacopeia (USP) monograph.
All three ingredients found in Midrin® have a USP monograph and can be ordered as a compounded medication by a prescriber for a patient seeking this therapy. Our goal as personalized medicine pharmacists is to meet the individual needs and circumstances of patients and practitioners. Headache patients may be at risk for suboptimal or nonexistent therapy following the discontinuation of Midrin® and Prodrin®.
Our pharmacists are available to discuss alternative therapies for Midrin® and Prodrin® patients. For more information, please call 407-260-7002.