FDA Orders 20 Unapproved Ergotamine Medications Discontinued

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Sun, 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...

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Nancy Harris Bonk

3/12/07 4:40pm

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.....

Teri Robert

3/12/07 5:47pm

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.

Dan

8/16/07 5:56pm

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

itsdebee@aol.com

10/27/07 2:00pm

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?

Linda Shafer

1/26/11 10:51am

The same thing happened to me when I tried to get my prescription refilled and I echo your response: how am I supposed to live the rest of my life now. I have been on this medication for over 20 years also and it has been the only medication that has given me some relief. I may still get a headache, but the intensity and the duration are manageable. They take this away and give us no viable substitute while they redo their "packaging". Does no one care about our pain?

Teri Robert

10/27/07 5:41pm

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

Migraine Mary

12/19/11 10:38pm

I was unable to locate migergot suppositories. Like the other commenters, I had been on the medication for 20 years. stopping the usage abruptly sent me to the emergency room and 3 days of being bed ridden with a migraine.

This is clearly an instance of the FDA fixing what is not broken. It's overreach when the FDA halts a medication that helps so many of us.

Is this medicine available in Canada?? Europe?? Arlene

Teri Robert

12/20/11 12:29am

Mary,

We can't blame the FDA for this one. The other ergotamine medications that were talked about in this article were removed from the market because they were developed before the current FDA approval process, and even though they had years to do it, none of the manufacturers did the clinical trials and applied for FDA approval. Not the FDA's fault.

The issues with Cafergot aren't the FDA's fault either. I've talked with people at some of the companies that were making Cafergot and its generics. The ones who have stopped making them stopped because there are no longer enough people using them for the companies to continue making them. If they were to continue making them, they'd have to charge terribly high prices just to break even on them. Nobody would pay those prices, so the drugs are being discontinued.

I'm really sorry for the situation you're in. There's also another issue here. Cafergot was never intended for frequent use. So, it's hard to blame anyone here -- the FDA, or the manufacturers. You're certainly not to blame either. It's a lousy situation. I'm really surprised that you had a prescription that supplied enough of it for you to get in this situation.

I'm continuing to track down companies that have made it to see if anyone is going to continue with it.

Teri

FDA Orders 20 Unapproved Ergotamine Medications Discontinued

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