How your Doctor can prescribe Domperidone

I got this off of the FDA website. I just went to the FDA site and did a search for Domperidone. If you think your doctor might be willing to prescribe it for you, then maybe you could print this off and give it to him or suggest it. It's pretty annoying- it is not approved for use for lactating women. So the rest of us have to suffer. There are plenty of drugs that pregnant or lactating women can't use that are still legal, I have no idea why domperidone isn't. There have also been some cardiac issues, but from what I have read it was with elderly, very ill patients who received it IV.

How To Obtain Domperidone

On June 7, 2004, the Food and Drug Administration (FDA) warned compounding pharmacies and firms that supply domperidone for use in compounding that it is illegal to compound domperidone and issued an import alert advising FDA field personnel that they may detain shipments of finished drug products and bulk ingredients containing domperidone. These actions were the result of the Agency's concern about the potential public health risks associated with the use of domperidone by lactating women. Although FDA has determined that domperidone should not be compounded or used to enhance breast milk production in lactating women, there are some patients with severe gastrointestinal disorders, such as severe gastroparesis or severe GI motility disorders that are refractory to standard therapy, who may benefit from the drug and in whom the drug’s benefits outweigh its risks.

FDA encourages physicians who would like to prescribe domperidone for their patients with severe gastrointestinal disorders that are refractory to standard therapy to open an Investigational New Drug Application (IND). An IND is a request for FDA authorization to administer an investigational drug to humans. Such authorization would allow the importation, interstate shipment, and administration of the drug even though it is not approved for sale in the U.S.

For questions relating to domperidone INDs contact the Division of Drug Information, toll free at (800) INFO-FDA or (301) 796-3400.

Date created: May 18, 2005, updated October 1, 2008

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It's so frustrating that evil Regaln is on the market, yet gentle Domperidone is not.

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No kidding. I have had literally no side effects from the domperidone, but it is working very well. The Reglan didn't work as well, and after five days of not even taking the full dose I was practically suicidal. I felt just horrible on it- had a bad headache, was really depressed or at least moody/irritable, and my wrists felt really weird.
It seems incredibly unfair that when you read the FDA statement about why it is not approved, it all has to due with its use as a lactation aid.
So... just don't approve it as a lactation aid, approve it as a GP drug.
Money has to be the bottom line here in some way.

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While I didn't respond to the Dom, I did eventually develop mild TD from long term Reglan use. It is very irritating that they are willing to say somehting with a black box label is safe to prescribe, but another with far fewer side effects is not.

They did the same thing with cisapride as well. It is like any drug. There are going to be those who are going to have reactions, it's a given. But you have to take into account the number of patients with reactions compared to the number of patients on the drug. It's beyond silly to me.

Diana

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Makes you wonder if the manufacturer's of Reglan, which is prescribed a lot, have some type of clout with the FDA to keep a safer alternative off the market (because who would use reglan then?). Did your TD clear up after you stopped using it?
I've also heard that zelnorm was a great drug for a lot of people but was taken off the market in a similar fashion.

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I asked my GP for a prescription and was met with a resounding NO. I'm going to try my new GI next. I think I'll meet with the same results, WI isn't big on doing anything new.

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I wonder why your GP was so negative about it?

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