tallicedvnowhip
Posts: 5
Joined: 5/30/2007
From: Seattle
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Domperidone has many of the same side effects as Reglan. The FDA issued a black box warning while I was taking it and has since withdrawn its approval.
Reglan and its generic Metoclopramide have been linked to a horrible debilitating condition known as Tardive Dyskinesia. The FDA warned of this condition on the product label, however, the chances of developing Tardive Dyskinesia from Reglan go up substantially the longer the drug is used. The drug is only approved for use for 4-12 weeks, but 1/3 actually take the drug for a year or longer, raising the risks for developing Tardive Dyskinesia to extremely high levels.
Tardive Dyskinesia is a neurological syndrome caused by the long-term use of neuroleptic drugs. Neuroleptic drugs are generally prescribed for psychiatric disorders, as well as for some gastrointestinal and neurological disorders.
Tardive dyskinesia is characterized by repetitive, involuntary, purposeless movements. Features of the disorder may include grimacing, tongue protrusion, lip smacking, puckering and pursing, and rapid eye blinking. Rapid movements of the arms, legs, and trunk may also occur. Involuntary movements of the fingers may appear as though the patient is playing an invisible guitar or piano.
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I have taken both at different times, and experienced side effects ranging from the unpleasant to the downright unspeakable ... but never lactation. (I only wish!)
Domperidone had a particularly nasty little habit of producing nightmares akin to demonic possession, something referred to in the accompanying literature as "vivid dreaming"... yeah,right. "dreaming."
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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 may 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
source: http://www.fda.gov/cder/news/domperidone.htm
ALERT: The agency has learned that domperidone, is being imported as a bulk API for pharmacy compounding and as a finished dosage form. The
importation of this drug presents a public health risk and
violates the Federal Food, Drug, and Cosmetic Act (the Act).
BACKGROUND: The agency is concerned about the public health risks
associated with domperidone which is not approved for any use
in the U.S. There have been several published reports and
case studies of cardiac arrhythmias, cardiac arrest and sudden
death in patients receiving an intravenous form of domperidone
that has been withdrawn from marketing in several countries.
Among other uses, FDA has become aware of the use of
domperidone by lactating women to increase breast milk
production because of the drug's effect on prolactin levels.
While domperidone is approved in several other countries for
the treatment of gastric stasis and gastroparesis, domperidone
is not approved in any country for enhancing breast milk
production in lactating women. In several countries where the
oral form of domperidone continues to be marketed, labels for
the product note that domperidone is excreted in the breast
milk of lactating women and recommend that women taking
domperidone avoid breast-feeding. Because of this, FDA
recommends that breastfeeding women not use domperidone to
increase milk production.
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I hope I haven't posted too much information here.
I just felt that it was important for anyone considering
the use of these drugs to know about the existence of this information.
I have accumulated a great deal of material on the topic of
lactation induction over the years.
I am happy to share with anyone who is interested, just email me!
Warmly,
Summer
< Message edited by tallicedvnowhip -- 6/4/2007 5:45:19 AM >
_____________________________
Forever,
Summer
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