Echocardiographic “Research”Case Definition for Valvulopathy with Appetite Suppressants

• Aortic Regurgitation (AR)

  > Mild
  
  
  and/or
  

• Mitral Regurgitation (MR)

  > Moderate
  

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3. The FDA "research" case definition for valvulopathy in the setting of appetite suppressant use was aortic regurgitation of greater than trace/trivial/minimal severity and/or mitral regurgitation of greater than mild severity, as documented by echocardiography. This definition was based upon review of case reports submitted through MedWatch, literature reports on the prevalence of valvular regurgitation in the general population, and consultation with cardiologists. From spontaneous case reports, we noted that isolated tricuspid regurgitation was rarely reported, and when reported, it was often associated with pulmonary hypertension. We concluded that in such reports, the pulmonary hypertension was probably primary in type, with secondary tricuspid regurgitation. The case reports suggested that the valvulopathy associated with appetite suppressant use was a disorder of the left side of the heart.