What is the status of ampligen, kutapressin and magnesium sulfate that received wide media attention during 1991 as treatments and/or cures for CFS?
Ampligen: On October 4, 1991, the FDA issued a statement advising they notified the manufacturer of ampligen that their application to provide the drug under a treatment IND for patients with CFS would not be allowed to proceed. • In addition to numerous deficiencies in the application, the FDA is concerned particularly about the serious and potentially life-threatening reactions that were observed during the study, and the conduct of the study in general. • These serious reactions included acute hepatic (liver) toxicity, severe abdominal pain and irregular heartbeat. • FDA Commissioner David A. Kessler, M.D., emphasized that it was important for CFS sufferers to know that the significant side effects associated with ampligen would have to be weighed against any claimed benefit before the drug could be approved for wide-spread use. • The FDA will continue to work closely with the manufacturer in an effort to resolve all issues. • (NOTE: It is our understanding that ampligen studies wil
