First there was the unintentional punch in the nose that Congress and the FDA gave to migraine patients when they threw isometheptene compounds (Midrin) off the market. Now, over the last year, things have gotten really tough for us headache doctors and for our patients trying to get safe, effective, non-opioid, non-barbiturate headache treatments. One by one some of our best meds have become scarce or completely unavailable.
Here's a list of medications we routinely use that are now scarce or completely unavailable:
- Ativan/lorazepam IV
- Compazine/prochlorperazine IV
- Depacon/valproic acid IV
- DHE IV/IM
- Droperidol IV
- magnesium sulfate IV
- Phenergan/promethazine IV
- Reglan/metoclopramide IV
- Toradol/ketorolac IV
- Zofran/odansetron IV
Nerve Blocks/Other injections
- Bacteriostatic NaCl (saline) 0.9%
- Lidocaine 1% and 2%
I heard a scary story from a headache patient today. She was having trouble getting her DHE, so her pharmacy found some, but would not sell it to her unless she paid full retail price and did not go through insurance.
Here is what is going on. Basically there is a low profit margin on generic drugs in the US. Medicare legislation reimburses for injectable generics at no more than 6% above the average sales price paid during the preceding quarter for any generic drug. For this (and other) reason(s), generic profit margins are very low. So, for business reasons, companies have purposefully kept inventories low and have not increased manufacturing. A series of natural disasters that took down drug manufacturing plants and FDA closings for manufacturing deficiencies have taken some plants off-line. The plants that remain are struggling to keep up production, and falling behind as demand continues. Scarce plant capacity may be allocated to chemotherapy or heart drugs at the expense of headache treatments.
I think headache patients are at particular risk. Because of a lack of research funding and, therefore, lack of new migraine drug development, we are mostly using older generic medications. Certainly nobody has been developing new IV migraine drugs for hospital and infusion center use. Many of the indications for which these old drugs were developed (they were never developed for migraine) have had newer drugs developed for this indication, while their use in headache was not supplemented by another drug. Finally, there is less of a movement to advocate for increased production of headache medicines compared to other types of medicine.
IV generics have been affected more than oral ones, and I am worried about the consequences. There is no way to know for sure, but I thought I had been seeing, gratefully, a slow move away from persons with migraine being given opioids (narcotics) in the emergency department, and an increased use of more effective non-narcotic options that don’t lead to medication overuse and occasionally addiction. In the last year, as these non-narcotic options have become unavailable, my sense is that this trend has been reversed. If it hasn’t, it soon will be as the shortages continue. I know of no shortage of IV opioids, nor of oral opioids or barbiturate containing pills (Fioricet).
What if the generic IV shortages hit oral headache meds? Imagine for a moment a shortage of amitriptyline (Elavil), a very commonly prescribed generic migraine preventive. Suddenly a million Americans (I would not doubt the number is that high) switch to other drugs, with resultant withdrawal symptoms, irritability, insomnia, new side effects from the substitute medications, and a loss of headache control. All this would require urgent doctor visits, emergency visits for migraine status, and exacerbation of other pain disorders, like diabetic nerve pain. I can tell you from long experience, transitioning off amitriptyline to another preventive can be extremely tricky. You don’t want to stop cold turkey. There is already a scary on and off shortage of indomethacin, a drug that is often the only thing that works for persons with several rare and very painful headache diseases like hemicrania continua and chronic paroxysmal hemicranias.
If headache drug development had kept pace with drug development in other areas, we would not be in this much of a pickle. The AHDA will continue to work for increased headache research and to increase awareness and find solutions for the problems of those with migraine, cluster headache, and other headache diseases.
William B. Young; MD, FAHS, FAAN
Jefferson Headache Center; Philadelphia, Pennsylvania
Vice President, Alliance for Headache Disorders Advocacy