FDA issues warnings on unapproved use of drug to boost breastfeeding.

Dear Reader,

In response to reports that women may be using an unapproved drug, domperidone, to increase milk production, FDA issued both a public health warning to caution breastfeeding women against using the product because of safety concerns, and several warning letters and an untitled letter to pharmacies that use domperidone in drug compounding.

Although domperidone may increase the secretion of prolactin, a hormone that is needed for lactation, it is not approved in any country for that purpose. However, the drug is approved in several countries outside the U.S. to treat certain gastric disorders.

According to FDA, 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arrhythmias, cardiac arrest and sudden death in patients receiving an intravenous form of domperidone that has been withdrawn from marketing in a number of countries.

In several countries where the oral form of domperidone continues to be marketed, labels for the product contain specific warnings against use of domperidone by breastfeeding women and note that the drug is excreted in breast milk that could expose a breastfeeding infant to unknown risks.

In the U.S., the Compliance Policy Guide issued on June 7, 2002, allows FDA to take action after considering whether a firm is compounding finished drugs from bulk active ingredients that are not components of FDA-approved drugs without an FDA-sanctioned investigational new drug application, as required. Other factors may also be appropriate for consideration, including factors that indicate that a compounded product may have a potential adverse affect on the public health.

Following its public health, the agency issued the following warning letters to manufacturers, compounders and distributors of domperidone, all dated June 7, 2004:

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Axium Healthcare Pharmacy, Altamonte Springs, FL, June 7 (Florida).

A Feb. 10-12 inspection by FDA investigator Brunilda Torres, the Florida State Bureau of Pharmacy Services, and the Florida State Investigative Services revealed that the pharmacy was compounding human prescription drugs in various strengths that included non-FDA-sanctioned domperidone and ribavirin capsules.

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Drugs Are Us, Inc., dba Hopewell Pharmacy, Hopewell, NJ, June 7 (NJ Central).

On Oct. 8-24, 2003, FDA investigators and the New Jersey Board of Pharmacy inspected the firm, which compounds human prescription drugs in various dosage forms and strengths. The inspection revealed the company was preparing and distributing domperidone 5-mg, 10-mg, 20-mg, 30-g, 40-mg capsules and 1-mg/ml and 10-mg/ml liquid suspension for human use. Additionally, FDA further objected to the pharmacy's compounding of drug products containing polidocanol, which is also not an active ingredient contained in any FDA-approved drug product.

13093W 7 Peoples Pharmacy, Inc., Austin, TX, June 7 (Dallas).

On April 14-17, 2003, FDA inspectors and the Texas State Board of Pharmacy inspected Peoples Pharmacy #1 in Austin. The inspection revealed the pharmacy was compounding and distributing 5-mg, 10-mg, 20-mg, 30-mg and 40-mg domperidone capsules for human use.

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Spectrum Chemicals & Laboratory Products, Gardena, CA, June 7 (NJ Central).

FDA conducted a Jan. 29-Feb. 5 inspection at the company's New Brunswick, NJ, location. Spectrum receives active pharmaceutical ingredients (APls) from manufacturers and distributors. These APls are subsequently repackaged and relabeled for further distribution to pharmacies for compounding. According to FDA, the firm was repacking and distributing the bulk API domperidone for use in pharmacy compounding.

CDER Untitled Letter

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Line Avenue Pharmacy, Shreveport, LA, June 7 (New Orleans).

An Oct. 9-24, 2003, inspection revealed the pharmacy was most likely compounding and distributing products containing domperidone, as well as drug products containing dimethyl sulfone, which is also not an active ingredient contained in any FDA-approved drug product.

FDA also is issuing an Import Alert, which alerts FDA field personnel to be on the lookout for attempts to import this drug so that it can be detained and refused admission into the U.S.

Sincerely,

The Editors Copies of all warning and untitled letters are available from RECORD-RETRIEVE. We also retrieve responses to these letters. Give us a call at [phone] or [e-mail]