Migraine Medications - DHE Shortage Continues - 07/22/14

Teri Robert @trobert Health Guide
  • As some of you have already discovered, there's currently a shortage of D.H.E 45 (dihydroergotamine mesylate), a commonly used migraine abortive medication. D.H.E 45 is used in several different ways:

    • Injected subcutaneously by patients at home as their first-line migraine abortive medication.
    • Administered IV or subcutaneously in the emergency room for migraine.
    • Administered via IV infusion in hospitals and some doctor's offices to break an intractable migraine.

    D.H.E 45 is currently produced by three manufacturers. Here are the reported reasons for the shortage and the dates by which resolution is predicted:

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    • Dihydroergotamine mesylate injection, Bedford
      • 1 mg/mL, 1 mL vial, 10 count (NDC 55390-0013-10)
      • Ben Venue supplies multiple sterile injectable products for Bedford Laboratories, and has stopped production in its plant in Bedford, Ohio, which will close in 2014. supplies of product that has already been manufactured will continue to be released until inventory is depleted.
    • Dihydroergotamine mesylate injection, Paddock Labs (Perrigo)
      • 1 mg/mL, 1 mL ampule, 5 count (NDC 00574-0850-05) and
        1 mg/mL, 1 mL ampule, 10 count (NDC 00574-0850-10)
      • Paddock states the reason for the shortage is manufacturing delay, and cannot estimate a release date.
    • D.H.E. 45, Valeant Pharmaceuticals
      • 1 mg/mL, 1 mL ampule, 10 count (NDC 66490-0041-01)
      • Valeant has D.H.E. 45 injection on back order and the company cannot estimate a release date.

    Summary and Comments:

     

    Migraineurs have few enough options for acute treatment without having to endure periods of shortage during which we cannot get our medications. with FDA approval of these medications comes an ethical, if not legal, responsibility to prevent these shortages.

     

    United States legislative bodies (the Senate and House) and regulatory agencies such as the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) should be reviewing laws and regulations to address medication shortages. When corporate mergers, buy-outs, and take-overs are proposed, the FTC should be looking at corporate records and not approving such events if the company that would take over the other has a history of long and unexplained shortages.

     

    Valeant, one of the D.H.E. manufacturers discussed above, is currently in the process of attempting a take-over of Allergan, the company that developed and is currently the manufacturer of Botox (onabotulinumtoxinA), the only treatment approved by the FDA for the treatment (prevention) of chronic migraine. This attempted "hostile" take-over has received quite a bit of attention lately. Given their lack of response to the D.H.E. shortage, the FTC should not approve such a take-over of Allergan by Valeant if it comes to the point of coming before them for approval.

     

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    Sources:

    American Society of Hospital Pharmacists. "Dihydroergotamine Mesylate Injection." Current Drug Shortages. July 9, 2014.
      

    Live well,

    PurpleRibbonTiny Teri1

     

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    Reviewed by David Watson, MD.


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    © Teri Robert, 2014, •  Last updated May 1, 2014.

     

     

     

Published On: July 22, 2014