Motilium (generic name: domperidone) is a medication which is used to treat nausea and vomiting and some gastrointestinal problems like gastroparesis, which is the discomfort caused by slow moving stomach contents. The symptoms include being unable to complete a meal, feeling bloated after a meal, suffering loss of appetite, feeling sick and belching without relief and even vomiting.
Numerous attempts have been made by the license holder since 1990 to get FDA approval for drugs that contain domperidone. However, according to the FDA website, domperidone is not currently a legally marketed human drug and it is not approved for sale in the U.S. The FDA took this action specifically because of concerns about some potential serious health risks when domperidone is used by lactating women to enhance breast milk production.
The FDA’s main concern was with the potential risks associated with domperidone following several published reports of cardiac arrhythmias, cardiac arrest, and sudden death in patients receiving an intravenous domperidone in other countries. However, domperidone is still approved for use as a treatment for gastrointestinal disorders in many other countries including Canada, Australia, the UK, the EU and Israel. In these cases, the oral form of domperidone contains warnings against use of domperidone by breastfeeding women and note that the drug is excreted in breast milk which could expose a breastfeeding infant to unknown risks, but they all authorize the prescription of Motilium for relief of nausea and gastrointestinal problems.Â
Despite its refusal to approve domperidone, the value of the drug has been acknowledged by the FDA and in the latest documents, the FDA recognizes that there are some patients with severe gastrointestinal motility disorders that are difficult to manage with available therapy for whom domperidone’s potential benefits may justify its potential risks. Patients 12 years of age and older with certain gastrointestinal (GI) conditions who have failed standard therapies may be able to receive treatment with domperidone through an expanded access investigational new drug application (IND). These conditions include gastroesophageal reflux disease with upper GI symptoms, gastroparesis, and chronic constipation.
What are the side effects of Motilium
Motilium is not generally used to treat chronic conditions, so the use of the drug will be limited to short-term doses and there are no reported persistent toxic accumulations. Motilium can produce some mild and short-lived side effects. Generally,these should be relieved as soon as the administration of the drug stops, which will be when the underlying symptoms have abated. The most common side effects are:- dry mouth
- abdominal cramps and/or diarrhea
- nausea
- rash, itching or hives
- headache
- dizziness
- increased nervousness or irritability
- flushing
- swelling or enlargement of breasts in men taking the drug
- suppression of the sex hormones in both men and women,
Specific side effects on lactating women
The effects on lactating women include breast enlargement, a nipple discharge unrelated to breast milk production, breast pain or tenderness, and menstrual irregularities. These are caused by elevated prolactin levels that may suppress the secretion of gonadotropin-releasing hormone (GnRH) from the hypothalamus, which causes a cascade of hormonal irregularities like suppression of follicle-stimulating and luteinizing hormones.ÂRare but serious side effects of Motilium
Notify your doctor and cease medications immediately if you develop any of the following:Â- chest pain
- changes in your heartbeat
- swelling of the feet or ankles
- difficulty urinating