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Domperidone

Domperidone (Motilium®) is an antidopaminergic drug used orally or intravenously, generally to suppress nausea and vomiting. It has also been used to stimulate lactation. more...

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Uses

Gastrointestinal problems

Domperidone is used, together with metoclopramide, cyclizine, and 5HT₃ receptor antagonists (such as granisetron) in the treatment of nausea and vomiting. It is useful in patients with Parkinson's disease because, unlike metoclopramide, domperidone does not cross the blood-brain barrier. Domperidone is also prescribed for the treatment of gastroparesis, a stomach motility condition.

Lactation

The hormone prolactin stimulates lactation in humans, and its release is inhibited by the dopamine secreted by the hypothalamus. Domperidone, by acting as an anti-dopaminergic, results in increased prolactin secretion, and thus promotes lactation.

Although it has never been officially approved for use in the United States, domperidone is widely purchased from pharmacies in other countries for this purpose.

Problems

In June 2004, the United States' main regulation agency, the Food and Drug Administration (FDA) issued a letter warning women not to take domperidone, citing unknown risks to parents and infants, and warned pharmacies that domestic sale was illegal, and that import shipments from other countries would be searched and seized. Individual incidents of problems with the drug include cardiac arrest and arrhythmia, complications with other medications, as well as complications with improper intravenous use.

It has been widely speculated that this action by the FDA is related to increasing drug importation from countries such as Canada. However, organisations such as the American Association of Pediatrics have endorsed the FDA action.

Yet prominent doctors and pharmacists have rejected the FDA's reasoning and still promote domperidone's use in increasing milk supply. Such doctors and pharmacists are confident the drug is safe in the doses given for this purpose. The American Academy of Pediatrics considers domperidone "usually compatible with breastfeeding."

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Warning letters
From Pharmaceutical Technology, 5/1/05

Palace Pharmacy. FDA's Denver, CO district office sent a warning letter to Palace Pharmacy (Lander, WY) concerning the company's drug-compounding activities.

The agency expressed special concern about Palace Pharmacy's production of domperidone in 10-, 15-, and 20-mg capsules for human use. The letter noted that domperidone (sometimes used to increase prolactin levels and improve breast milk production) is not approved for any human use in the United States, is not approved for enhancing lactation in any country, and has cardiovascular side effects that have forced its witdrawal from the market in several countries where it had been approved to treat gastric stasis and gastropaiesis.

FDA warned Palace that the current domperidone label "fails to bear adequate direction for their use" and that the products themselves are unapproved drugs under 21 CFR [section] 201.115.

Germiphene. In April, FDA released a warning letter to Germiphene Corp. (Brantford, Ontario, Canada, www. germiphene.com), citing significant deviations from US Current Good Manufacturing Practice regulations.

The five-page letter, dated Feb. 15, stated that employees at the inspected manufacturing facility lacked the education and training required to perform their assigned functions, and that the laboratory facilities and equipment used for testing and approval or rejection of components and drug products were found to be inadequate. Other violations included the use of instruments/apparatus not meeting established specifications, and an inadequate stability testing program.

In addition, Germiphene's labeling was found to be "seriously deficient for marketing the products in the United States." The products were therefore misbranded, and in some cases unapproved new drugs, including the company's fluoride products, "Denti-Care" oral rinse products, and over-the-counter healthcare products, which were found to contain an non-FDA approved combination of tetracaine and benzocaine.

In the letter, FDA recommended the disapproval of any new applications listing Germiphene as manufacturer until the deficiencies observed have been corrected.

In a statement to Pharmaceutical Technology the drug manufacturer said, "Germiphene Corp. takes the FDA comments very seriously and is addressing their concerns. We believe the issue will be concluded shortly."

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