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Motilium--Why not FDA approved?

2932 Views 13 Replies 7 Participants Last post by  DonnaDB
I have been researching on the drug known as Motilium (domperidone) for gastroparesis. Does anyone know why is is not FDA approved in the US?? According to most of the info on the net, it is basically a very benign drug with very few side effects. I just ordered some and can't wait to try it!! At this point, I'm willing to try DRANO if I thought it would help!!
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how did yuou find out how to order it if it's not approved? may just be OTC?tom
Probably because the FDA approval process is very stringent so it costs lots of money to get a drug approved and there is a chance it won't be approved, thus wasting all that money. On other hand, since the loss of cisapride, there is a definitely a market for drugs of this type and there are other drugs related to cisapride that are being looked at it.
Motilium is available OTC over here and I take it for nausea. (In fack I've got some in my bag right now) It works really quickly and I haven't had any side affects with it.
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I am not aware that it has been approved in the USA. I have tried it but had not luck and all, neither good nor bad ... kinda made no difference. In some countries it is and OTC drug, in others in requires a prescription. Apparently it has very few mild side-effects.I have no idea why it hasnt been approved in the USA, we seem to be the slowest most conservative country in the world when it comes to medicine, and one of the most unhealthiest. hmm, makes one wonder!?
Not all drugs developed worldwide are brought to the FDA for approval.I don't know if the company that produces this drug tried to get FDA approval or not. Just because it is not approved here doesn't mean that it has been through the approval process and failed. The company may not feel the need to go through the time, effort and expense to attempt bringing the drug to the US market.The FDA has no power to force a company to bring a drug to market in the US. The company has to initiate the approval process. The FDA cannot go out and track companies down and force them to get approval.K.
Thanks for all of your responses. If you are really interested in it, go to your search function and just type in the word motilium. There are at least 100 foreign pharmacies that will ship it to the US. I sure hope it helps me!!! I'm at my rope's end!!
what is it supposed to do? Is it like zelnorm?tom
Tom, If I understand it correctly, it is simply a peristaltic enhancer. It helps the bolus move along more efficiently through the stomach and bowel. I am hoping that it will help with my pain!
like lactolose? Did your doctor suggest it? tom
quote:like lactolose?
No, it helps increase esophageal motility and gastric emptying. Probably no signficant effect on other bowel parts.
I agree with flux. Thats the same experience I had. It kind of works in the upper part of the digestion process and has not effect on the colon at all. I would imagine it may be good for people who cannot keep food down or get nausea, however it is not relevant for constipation ... would just be kind of adding more useless toxins into our system, which I dont thing any of us need.Sorry I couldn't give you any good news about this.
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How similar is Motilium to Metaclopramide (Reglan)? I have tried Metaclopramide, and for me, it helps reflux, and, to a lesser degree, nausea. I know its mostly for gastroparesis so I'm not surprised it doesn't do a whole lot for me, I have small bowel problems.Slacker
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It is very similar except that is reportedly has fewer side effects than Reglan.
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