Midrin for Migraine: What's Going On?
For the latest update on this situation see Migraine Meds Epidrin, Midrin Update 1/28/11. For many migraineurs, Midrin has been the best medication they’ve ever found for treating their migraines.
For many migraineurs, Midrin has been the best medication they've ever found for treating their migraines. For some with a history of or risk factors for stroke and other cardiovascular issues, it's been the only abortive medication considered safe for them.
In 2007, Midrin was unavailable for a time because of a shortage of one of the ingredients. When this was resolved, Caraco (the manufacturer) was able to start making and shipping it again. Later on, Caraco ran into some issues with the FDA regarding some manufacturing issues. When the dust settled, they permanently discontinued manufacturing brand name Midrin.
For some time, we could find the same medication available under the names Epidrin and Duradin; then the "generic" isometheptene mucate/dichloralphenazone/acetaminophen. Over the last few months, migraineurs have been reporting more and more problems getting any version of this medication. I had researched it and found it to supposedly being manufactured still, and my local pharmacies could get it.
However, due to increasing problems, I emailed the FDA this morning to get an update. Here is the reply I received:
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: FDA US Food and Drug.
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.
Drug Information RL
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
So, there you have it, the lastest information directly from the FDA. I did reply to the email, explaining that Midrin is the only migraine abortive medication not contraindicated for people with cardiovascular risks or history of cardiovascular issues. I asked them if there is some way for us to contact someone at the FDA to voice our concerns and try to keep this medication available. I'll keep you updated on their reply.