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FDA Orders 20 Unapproved Ergotamine Medications Discontinued

Teri Robert
Teri Robert
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Author of "Living Well with Migraine Disease and Headaches"

Patient advocate and writer Teri Robert's career moved in this...

Teri Robert

Sunday, March 11, 2007
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The FDA has issued letters to eight pharmaceutical manufacturers and 12 distributors warming them to stop marketing and distributing 20 unapproved ergotamine tartrate medications used to treat Migraine attacks and vascular headaches. Steven Galson, M.D., director of the FDA’s Center for Drug E...
  1. Really!
    Nancy Harris Bonk
    Monday, March 12, 2007 at 04:40 PM

    Thank you for bringing this vital information to our attention.  As we like to say an informed patient is an educated patient.

     

    Kind of scary though.....

    Reply
  2. Nancy
    Teri Robert
    Monday, March 12, 2007 at 05:47 PM
    Nancy,

    We've both seen people talk on the forum about taking these meds. Until this came out, I had no idea that they weren't FDA approved or that it was even possible for companies to continue manufacturing and distributing meds that weren't. Dr. K. raised a good point that these are ergotamine meds with very high rebound potential too.

    You're right, it is a bit frightening.
    Reply
  3. FDA Orders 20 Unapproved Ergotamine Medications Discontinued
    Dan
    Thursday, August 16, 2007 at 05:56 PM

      I have been taking this medicine for over 15 yrs. and have not experienced these rebound headaches tht were mentioned.  Additionally, the first I heard of this discontinuing of this medicine is when I went to refill my prescription and was told that all medicines and alternatives have been discontinued, without any explanation as to why.  I was given the last twenty pills the pharmacy had.  Now, I have to find an alternative medicine, while also trying to ween myself off of this stuff because stopping cold turkey can cause seizures.  How scary is that?

     

    Dan

    Reply
  4. withdrawals
    itsdebee@aol.com
    Saturday, October 27, 2007 at 02:00 PM
    I, too, have been on this medication for over 20 years without suffering from rebound headaches.  I did quit, once, at the request of a sinus doctor and suffered from facial swelling and horrible headaches for 10 days.............then finally returned to normal. I went back on them as my migraines increased in frequency and strength without this medication.  I have tried all the "latest" other migraine medications without success, so I am left wondering how I am going to get thru my life now.  I, too, found out they were discontinued when I tried to refill my prescription and found there were none available.  I did manage to come up with a months supply and will try to gradually decrease the dosage if my neurologist can't suggest an alternative.  I am very disappointed with the fda on this call..............the imitrex drugs can cause heart attacks.................................this is a much safer, fewer side effects drug..............shame on them for putting us in this position............How could these not have been approved when I have been on them for more than 20 years?  WHO hasn't been doing their job?
    Reply
  5. itsdebee
    Teri Robert
    Saturday, October 27, 2007 at 05:41 PM

    Hi, itsdebee,

     

    I don't always agree with the FDA, but I do on this one. Any drug we use should go through the full approval process. The drugs that were withdrawn had not.

     

    For the record, the ergotamine meds are also contraindicated for anyone with heart problems, just as the triptans are. More people die from reactions to penicillin than have had heart attacks caused by Imitrex and the other triptans. When prescribed correctly and used as prescribed, the triptans are very safe.

     

    I don't know how the withdrawn drugs hit the market without approval and haven't really been able to find out. I'd like to know too.

     

    Teri 

    Reply
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