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FDA Warns Against Women Using Domperidone, to Increase Milk Production

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eMediNexus    21 February 2018

Women may be using an unapproved drug, domperidone, to increase milk production the US Food and Drug Administration (FDA) is warning breastfeeding women not to use this product because of safety concerns.

 Domperidone increases the secretion of prolactin, a hormone that is needed for lactation. 30-40 mg dose the effects can be seen.

Domperidone is approved in India to treat certain gastric disorders, it is not approved in any country for enhancing breast milk production in lactating women and is also not approved in the U.S. for any indication.

There have been several published reports of cardiac arrhythmias, cardiac arrest, and sudden death in patients receiving an intravenous form of domperidone.

Domperidone may increase the risk of cardiac arrhythmias therefore, an electrocardiogram should be performed at baseline and while on treatment. Domperidone should be withheld if the corrected QT is >450 ms in men and >470 ms in women.

The chance of abnormal heartbeats or sudden death are higher when used at doses more than 30 mg per day or in patients older than 60 years.

All ‘D’ preparations contains domperidone 10 mg and ‘D-SR’ preparations contains domperidone 30 mg

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