FDA Cracks Down on Quinacrine Sterilization

Date Published: July 17, 2006
Source: Wall Street Journal, October 19, 1998, C17; and Quinacrine Alert inside this newsletter

On October 14, the US Food and Drug Administration issued a warning letter to Drs. Elton Kessel and Stephen Mumford, stating that sterilization is an unapproved and unsafe use of the drug quinacrine. Under FDA supervision, Kessel and Mumford must destroy their supply of quinacrine pellets. According to the letter, "The product at issue does not meet even the threshold requirement for export in that it is not approved for use in nonsurgical female sterilization in any country." However., it is unclear to what extent the FDA action will halt the distribution of quinacrine pellets either outside or inside the US since Mumford told The Wall Street Journal that arrangements had already been made to manufacture and distribute them overseas.