Warning Letter: Cape Drugs

Warning Letter: Cape Drugs

On July 11, the US Food and Drug Administration sent a warning letter to Cape Drugs (Annapolis, MD) concerning the company’s compounding of domperidone, a drug not approved by FDA.

According to the warning letter, there have been several published reports linking domperidone to cardiac arrhythmias, cardiac arrest, and sudden death in patients receiving an intravenous form of the drug. FDA notes use of the drug by lactating women to increase breast milk production, but the drug is not approved for this use in any country. Several countries have approved domperidone for treatment of gastric stasis and gastroparesis.

FDA also charged that the products were misbranded and that the labels fail to list adequate directions for use.

–George Koroneos