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Please note: FDA has not yet concurred in this suggested wording and is presently considering Medeva's proposal, along with those of other manufacturers of the involved products. Once all proposals are submitted and evaluated, FDA will request labeling changes that it believes most appropriate in light of the continuing information being accumulated about the use of these drugs.
August 8, 1997
Dear Health Care Professional:
Medeva Pharmaceuticals, Inc. would like to inform you of important upcoming labeling revisions for IONAMIN (phentermine resin) Capsules C-IV which will warn against unapproved use of IONAMIN Capsules in combination with certain appetite suppressants, such as fenfluramine and dexfenfluramine. The revised labeling will also emphasize the indication of IONAMIN Capsules in the management of exogeneous obesity as a short-term adjunct in a weight loss regimen based on exercise, behavioral modification and caloric restriction.
A boxed warning that a rare type of valvular heart disease has been reported in patients taking phentermine in combination with fenfluramine will be included in the revised labeling. While no causal relationship between valvular heart disease and the treatment of obesity with combinations of phentermine and fenfluramine has been established, given the seriousness of the reported valvular heart disease, health care professionals should be aware that this possible association has been reported.
The revised IONAMIN Capsules labeling will also warn that certain appetite suppressants have been reported to be associated with an increased risk of primary pulmonary hypertension (PPH), a serious condition. In the U.S., reported cases of PPH associated with appetite suppressants have been primarily in patients using combinations of phentermine and fenfluramine.
Treatment should be discontinued in patients who develop new, unexplained symptoms of dyspnea, angina pectoris, syncope or lower extremity edema. Those patients should be evaluated for the etiology of these symptoms and the possible presence of pulmonary hypertension or valvular dysfunction. Patients should be advised to report immediately any reduced exercise tolerance.
IONAMIN Capsules are not recommended or approved for use in combination with appetite suppressants such as fenfluramine and dexfenfluramine and should only be used as a short-term adjunctive treatment for exogenous obesity.
Medeva Pharmaceuitcals will send you the revised IONAMIN Capsules labeling when the wording is finalized with the FDA. If you would like additional information about IONAMIN Capsules, please contact our Medical Services department at 1-800-234-5535.
Sincerely,
Terrance C. Coyne, M.D.
Vice President, Medical Affairs
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