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Executive Summary

BOOTS MANOPLAX (FLOSEQUINAN) BLACK BOX WARNING will state that the heart failure drug "should only be used in patients who are willing to accept the risk of death," FDA Cardio-Renal Drugs Division Director Raymond Lipicky, MD, said at a June 3 FDA advisory committee meeting. Describing to the Cardiovascular & Renal Drugs Advisory Committee FDA's thinking on Manoplax labeling changes, Lipicky said the black box warning also will contain mortality results from an interim analysis of the Prospective Randomized Flosequinan Longevity Evaluation (PROFILE) trial in patients with severe congestive heart failure. Manoplax labeling is "currently being changed" in light of the PROFILE data, Lipicky told the committee. In addition, the warning will advise physicians "that they should discuss with the patient why [he or she is] receiving flosequinan," Lipicky said. The PROFILE study data, indicating a significantly increased risk of death in Manoplax patients, prompted Boots to send an April 23 "Dear Doctor" letter to 226,000 health care providers ("The Pink Sheet" May 3, T&G-1). Information to patients also is being changed with the addition of a patient package insert that will "talk about the risks of mortality that were described in the PROFILE study, alert patients to other side effects, inform the patients that they might want to read the full labeling, go through a detailed listing of what kind of patients would receive the therapy and what kind of patients should not, and advise patients to discuss why they are receiving the drug with their physician in the event that they have not discussed it," Lipicky explained. Furthermore, the dosage and administration section will contain a statement to the effect that the 100 mg dosage is not currently recommended but will not say specifically "don't use 100 mg," Lipicky said. Manoplax was approved at the end of 1992 for patients intolerant to other therapies and as add-on therapy with angiotensin converting enzyme inhibitors for patients remaining symptomatic on ACEs alone ("The Pink Sheet" Jan. 4, p. 15). Boots launched the drug at the end of March in strengths of 50, 75 and 100 mg. Lipicky and the committee members agreed that Manoplax should be addressed by the group at its scheduled October meeting if the PROFILE data are ready. PROFILE investigator Milton Packer, MD, Columbia Presbyterian Medical Center, told the committee that data should be ready by September or October. Boots has made a $4.6 mil. ((British Pound) 3 mil.) provision in its recently closed fiscal year (ended March 31) for costs associated with the preliminary negative PROFILE results. The firm said that Manoplax sales "appear consistent if not growing," and that there is a "continuing demand from clinicians." Manoplax was launched in the U.K. on Sept. 21, 1992.

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