FDAnews Drug Daily Bulletin


Aug. 22, 2005

The FDA has issued a warning letter to a Maryland pharmacy accused of compounding human prescription drugs containing the unapproved active pharmaceutical ingredient (API) domperidone.

The July 11 warning letter, recently released by the FDA, orders Annapolis, Md.-based Cape Drugs to immediately cease compounding products that contain domperidone, which has increasingly been marketed as a treatment to help lactating women increase breast milk production. Domperidone is not an API contained in any FDA-approved drug product.

The agency noted that while domperidone is approved in several other countries for the treatment of gastric stasis and gastroparesis, it is not approved in any country for enhancing breast milk production. The FDA further warned that domperidone has been linked to numerous adverse events, including cardiac arrhythmias, cardiac arrest and sudden death.

The FDA has been monitoring domperidone compounding closely in recent years. In June 2004, the agency issued warning letters to five U.S. pharmacies found selling domperidone products.

To view the warning letter to Cape Drugs, go to http://www.fda.gov/cder/warn/2005/cape_drugs_wl.pdf (http://www.fda.gov/cder/warn/2005/cape_drugs_wl.pdf).