Heart disease Phentermine

Common adverse reactions seen with phentermine use include heart palpitations, tachycardia, elevated blood pressure, stimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, dry mouth, constipation, and diarrhea. Phentermine should be avoided in patients with unstable cardiac status, hypertension, hyperthyroidism, agitated states, or glaucoma. In combination with fenfluramine or dexfenfluramine, pulmonary hypertension and valvular heart disease have been reported. The risk of developing either serious adverse effect cannot be ruled out with use of phentermine alone. Since phentermine is related to the amphetamines, the... 

Conelly, H.M., Crary, J.L., McGoon, M.D. Hensrud, D.D., Edwards, B.S., Edwards, W.D., SchafF, H.V. (1997) Valvular heart disease associated with fenfluramine-phentermine. The New England Journal of Medicine, 337, 581—588. 

Connolly HM, Crary JL, McGoon MD, et al. Valvular heart disease associated with fenfluramine-phentermine. N Engl J Med 1997 337 581-588. 

In March of 2002, Public Citizen filed a petition calling for the FDA to ban Meridia. Public Citizen quoted from FDA documents that showed that use of sibutramine was allegedly associated with 29 deaths and 400 adverse medical reactions. Those incidents occurred throughout the world, and Italy had banned the drug. The issue was also being studied by the United Kingdom, which banned phentermine in 2000. The ban was prompted by concern that it could cause heart disease. 

Burger AJ, Sherman HB, Charlamb MJ, et al. Low prevalence of valvular heart disease in 226 phentermine-fenfluramine protocol subjects prospectively followed for up to 30 months. J Am Coll Cardiol 1999 34 1153-1158. 

The fenfluramines and phentermine can cause valvular heart disease (8-10), and this has been reviewed (11). Fenfluramine was voluntarily withdrawn by the manufacturers on 15 September 1997, and the US Department of Health and Human Services issued interim recommendations for people previously exposed to fenfluramine or dexfenfluramine with cardiac valvulopathies (SEDA-22, 3). 

Tovar EA, Landa DW, Borsari BE. Dose effect of fenfluramine-phentermine in the production of valvular heart disease. Ann Thorac Sing 1999 67(4) 1213-14. 

Bruce CJ, Connolly HM. Valvular heart disease, pulmonary hypertension and fenfluramine-phentermine use. Cardiol Rev 1998 15 17-19. 

In September 1997, the FDA requested the manufacturers of fenfluramine and dexfenfluramine to voluntarily withdraw their products from the market. This was done following case reports of valvular heart disease in patients taking either medication as monotherapy or in combination with another anorexic agent, phentermine. Because no association has been found between phentermine alone and valvular heart disease, it is still available. Isolated case reports of pulmonary hypertension and phentermine monotherapy have been reported, but present data do not support an association. Although fenfluramine and phentermine were both approved by the FDA to be used as anorectic agents, the combination therapy, fen-phen, was never approved. 

The beneficial effect of steroid therapy was confirmed 8 years later in a larger group of patients [23]. Curiously, an asymptomatic aortic insufficiency was observed in one third of the patients with CHN [19, 24]. This cardiac complicafion was supposed to be the result of an extrarenal toxicity of Chinese herbs [25]. However, the attention was drawn to the role of appetite suppressants in the development of valvular heart diseases [26]. Since most of the CHN patients we have seen have been given appetite suppressants (fenfluramine, dexfenfluramine, phentermine alone or in combination) besides the Chinese herbs, the puzzling association of aortic insufficiency with CHN may more likely be linked to the concomitant use of (dex)-fenflu-... 

E. Prolonged use (usually 3 months or longer) of fenfluramine or dexfenflu-ramine in combination with phentermine ( fen-phen ) has been associated with an increased risk of pulmonary hypertension and of fibrotic valvular heart disease (primarily aortic, mitral, and tricuspid regurgitation). The pathology of the valvular disease is identical to that seen with carcinoid syndrome. 

Fenfluramine and dexfenfluramine have generally been withdrawn worldwide because of the occurrence of serious and sometimes fatal valvular heart disease (aortic, mitral, tricuspid or mixed valve disease). Pulmonary hypertension has also sometimes been seen. These serious adverse effects occurred when these drugs were taken alone, and when combined with phenter-mine as Fen-phen and Dexfen-phen, but not with phentermine alone. ... 

Connolly HM, Crary JL, McGoonMD, HensrudDD, Edwards BS, Edwards WD, SchaffHV. Valvular heart disease associated witii fenfhnamine-phentermine. NEnglJMed( 99T) 337, 581-8. 

In 1997, the manufacturers withdrew fenfluramine and dexfenfluramine from the market. Phentermine is still sold because no cases of heart valve disease were reported when that drug was taken alone, according to the FDA report. 

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