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FDA limits the use of quinacrine Posted 10-26-98 The Food and Drug Administration has issued a warning letter to two American researchers requesting that they halt distribution of the drug quinacrine for use in a controversial female sterilization method. The researchers, Elton Kessel, MD, PhD, and Stephen Mumford, DrPH, also were asked in the Oct. 14 letter to "voluntarily destroy" their supply of quinacrine under FDA supervision. The pair was instructed to report within 15 days to the author of the letter, Bradford W. Williams, director of the FDA’s Division of Labeling and Nonprescription Drug Compliance Center for Drug Evaluation and Research. Mumford said that there were approximately 300,000 tablets in his possession, but that he and Kessel were still deciding how, if at all, they would comply with the FDA’s demands. Larry Bachorik, an FDA spokesperson, said the agency would not comment on pending regulatory actions. Quinacrine was originally developed as an oral treatment for malaria and is currently used to treat giardia, as well as some patients with cystic fibrosis and lupus. When used for female sterilization, approximately 250 mg of the drug, in pellet form, is inserted into the uterus. Quinacrine reacts with the mucosal lining in the fallopian tubes to create scar tissue, which blocks the release of eggs into the uterus. The procedure is done twice, after menses in consecutive months, to increase the efficacy of the method. Approximately 100,000 women worldwide have been sterilized using quinacrine, mostly in the Third World, though no global health organization has sanctioned it. Quinacrine has been banned in several countries, including Vietnam, where 107 women were unknowingly sterilized in 1992. "Regardless of what my other fears may be, the most basic research has not been done," said Adrienne Germaine, president of the International Women’s Health Coalition. "We have established biomedical and ethical principles for the research process. And the basic animal studies have not been done for this drug." Related Sites
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