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Reglan in the national news

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Hi everyone-
This was on MSNBC.com this a.m. and I thought I'd share it with you all. It's not new info. to most of us, but it was nice to see that more focus is being placed on the possible side effects from Reglan-happy Friday! Mphotographer

MSNBC.com

Heartburn drug tied to muscle spasms, tics
FDA slaps strong warning on Wyeth’s medication Reglan
The Associated Press
updated 4:27 p.m. MT, Thurs., Feb. 26, 2009
WASHINGTON - Federal health officials are adding their sternest warning to a heartburn drug from Wyeth that has been linked to muscle spasms.

The Food and Drug Administration said Wyeth's pill Reglan has been shown to cause spasms and tics when used for long periods of time or at high doses. The agency is requiring both Wyeth and generic drugmakers to add a black box warning, the most serious type available, to their products.

Manufacturers also will be required to distribute medication safety guides to patients.

The drug's current labeling already mentions risks of developing the spasms, called dykinesia, but the agency's action Thursday elevates the warning to the top of the label. Reglan, known generically as metoclopramide, comes in a variety forms, including injections and edible syrups. The drug works by speeding up the muscles used in digestion and relieving painful stomach acid reflux.

More than 2 million U.S. patients use the drugs, according to the FDA.

"The chronic use of metoclopramide therapy should be avoided in all but rare vases where the benefit is believed to outweigh the risk," said Dr. Janet Woodcock, director of FDA's drug center.

Regulators said patients who face the greatest risks include the elderly, especially women, and those who have been taking the drug for more than three months.

The agency based its decision on recently published studies suggesting metoclopramide is the leading cause of pharmaceutical-related movement disorders.

Wyeth representatives had no immediate comment Thursday afternoon. The Madison, N.J.-based company recently was acquired in a $68 billion deal by Pfizer, the world's largest drugmaker.

16 replies

Reglan is a nasty drug. It helped me the most but I couldn't stand the side effects. I got muscle pain and a stiff neck from it. I heard you shouldn't be on it for more than twelve weeks anyway. It's not a long term solution drug.

Reglan has been on the market for years. The dyskinesia has been well documented for all those years. Long term use can cause an irreversible dyskinesia. It is a God send for many (such as myself) and the risk/benefits need to be discussed in depth with your doctor. There are other promotility drugs available, such as Domperidone, but this is not available in the US (need to get it from a foreign country such as Canada). Last I checked, Propulsid can still be obtained with MUCH documentation but I am not 100% certain on that.

Teresa

I was on Reglan for four months. Although it helped with the GP symptoms the doctor never told me that it can also cause severe depression and bone-numbing fatigue. Thank God, I got off of it before I committed suicide. Reglan is used routinely by doctors but the tics and muscle spasms are the only side effects mentioned. After doing my homework, I told the doctor that I was goin off of the Reglan and needed the domperidone. I felt like I knew more than my doctor did when it came to Reglans side effects. Scary drug that may help some but the vast majority of GP sufferers can't take it. All the more reason for more research and find new drugs to treat GP.

Hi Annie!

How was your trip? Glad to hear you are back on the forum.

Reglan never worked for me. I was on it for a couple of years with only a short break in between. I started getting the jerking movements of my limbs. I'm glad it did not get worse. I think that Jen is probably happy to hear that Reglan is finally getting the negative publicity it deserves!

Mimi

Hi Sonnillion, Teresa, Annie, and Mimi-
Thanks for your posts. I too tried Reglan when I was first diagnosed with GP and it didn't do anything for me except keep me on edge and up at night. I kept telling the doctors about me fears of the drug after reading about the possible side effects (and sometimes permanent side effects) and they were real casual about it. I am glad to see more press given to such a drug that can cause so many other issues. Take care and I hope everyone has a good stomach day-Mphotographer

Hi Mimi

Believe it or not, we're still in Mexico. Got another 12 days before we have to be home.
As to Reglan, we all need to push our doctors for more understanding and research on this condition. I'd love to see a national GP group formed that pushes for more funding. With so many millions suffering from GP, you would think that would be better drugs to help treat it.

I agree with you, Annie. However, I wonder how many cases of GP each GI doctor sees, because they don't seem to know too much about it. It just seems crazy that domperidone is not approved in the US by prescription from a GI doctor. Like maybe they would have to put a diagnosis on the prescription with an ICD9 number. That happens with some drugs, I don't understand why it can't with domperidone.

Anyway, I hope you have a wonderful rest of your trip! We are getting snow here - another 12-18 inches between today and tomorrow!

Mimi

Mphotographer:

I sure hope your doctor takes you more seriously now!

Mimi

Hi everyone and thanks for your posts on the subject of Reglan. I think Annie has a great idea-I'd love to see a national GP forum to push for more funding for research of this unique condition. I just received the latest newsletter from the Mayo Clinic (my mom started me a subscription) and there was an advertisement for a book on Digestive Disorders and GP was not even listed. And this is from the Mayo Clinic!

I too wish the doctors would not push Reglan on people. I agree, for some people that have GP with really bad symptoms, it might be worth trying it and it has helped some people who don't develop the bad side effects, but....I was terrified to try it and was basically forced into trying it when I was first diagnosed. It didn't do anything for me so I got off it quickly and luckily didn't get the tremors. Maybe the Mayo Clinic will come up with a better alternative since they are doing continuous research.

I am glad to see these discussions going on in our group as people that are newly diagnosed with GP need to really way the pros and cons of taking this drug-Mphotographer

It also causes/worsens depression. Which my GI did not take seriously enough. I have a new GI. The round of steroids to recover from being ALLERGIC to it was horrible too.

Wow i'm so glad my doc only had me on this for a few months. I am only 27 and he told me it had really bad side effects, but I had no idea it could get that bad that fast. Thank you for the info-I will never take this drug again

Hi Carebear-I am glad you never had the bad effects of Reglan. It's too bad they haven't come up with any other drugs that really help decrease our symptoms....without causing more problems! Thanks for your post and I hope today is a good stomach day for you-Mphotographer

I have been on Reglan for a few weeks now what 8-10 weeks, something like that. My doc was cashual aout Reglan too. I have had some mild tremor in my thighs. Should I be worried?
Rega

Others can respond to this question better than I can, rega, as I was only on Reglan for a very short time, but...I would definitely tell your doctor and ask him if you need to try something different since it appears that you are experiencing some of the side effects-Mphotographer

Can anyone tell me from their own experiences if the dykinesia symptoms go away completely when reglan is stopped?

Reglan. (I called it simply metaclopramide.) Day 1, twitchy legs, day 2 leg shakes, by day 3 the arms were shaking too, I was sleeping 15 hours a day, and felt alarmingly weird. I was heading for convulsions. So I had to stop.
The damnable thing was, it helped my peristalsis, and was the only drug that did ( and I tried them all). But over the next 3 days, as the side effects wore off , so did the benefits. Finally I hit a major logjam, and was beside myself for a good spell. I had to stop eating anything for 3 days, then very, very gradually introduce prescribed feeds. Never again.
So, be very careful, I'd say.
My options are now purely surgical, though I have high hopes for my imminent pacemaker.
For me metaclopramide will always be the one that got away - so close, but at what a price.

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