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Lilly's action followed hearings before a House subcommittee, during which FDA Commissioner Arthur Hayes Jr. said reports of 61 Oraflex-linked deaths in Britain and eleven in the U.S. were under investigation. An internal FDA memo given to the committee charged that in its application for approval of Oraflex in 1980, Lilly had seriously underreported the incidence of some negative side effects, such as failing to acknowledge 65 out of 173 cases of nonfatal adverse reactions. (It did report them later.) The memo said that some of the firm's reports to the FDA were "untrue...
...suspension of Oraflex in Britain, where it had been sold for the past two years under the name Opren, took place years under the name Opren, took place after the Committee on Safety of Medicines, the equivalent of the FDA, reported that it had received notice of more than 3,500 adverse reactions linked to the drug, including the 61 deaths, many of them associated with liver, kidney or gastrointestinal damage. U.S. consumer groups contend that there was no way that Lilly could not have known about the 28 British deaths that occurred prior to the drug...
...Lilly sent out a letter to U.S. physicians emphasizing that elderly people with impaired kidney or liver functions should not be given the full recommended dosage of the drug. Last week a Lilly research vice president denied knowing about the British fatalities from liver disease until informed by the FDA in May. For his part, FDA Commissioner Hayes testified that his agency did not learn of them earlier because "we don't have the wherewithal to solicit information from all countries where a drug is used...
...million patients who have taken it, Lilly maintains, and is "safe and effective when used as directed." In an earlier statement, Lilly took "vigorous exception to any implication that it has withheld data, maintained inadequate records or failed to comply with the scientific requirements of the FDA...
...serum cholesterol levels dropped 10%. How soon will SPE be on your grocer's shelf? Not for a long time, if ever. Though no serious side effects were reported, SPE is "potent stuff," says Dr. Charles Glueck, who headed the study. The compound has been classified by the FDA as a drug. When it becomes available, several years from now, it will be sold by prescription only...