[U.S. Food and Drug Administration/CDER]

Information Requested for MedWatch Reports of Valvular Dysfunction
with use of Appetite Suppressant Drugs

1. Patient age, sex, weight, height, blood pressure.

2. Daily dosage of fenfluramine, dexfenfluramine, phentermine.

3. Duration of use of appetite suppressant drugs.

4. If patient was no longer taking appetite suppressant drugs at the time of echocardiography, the interval of time since stopping use of these products.

5. Clinical history including symptoms (if any) and presence/absence of an audible cardiac murmur.

6. Echocardiogram results:

    1. Presence of regurgitation at each valve, especially at the aortic and mitral valves.
    2. Severity grading of regurgitation.
    3. Presence of pulmonary hypertension and estimated pulmonary artery pressure.

7. Use of other medications.

 

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November 13, 1997
http://www.fda.gov/cder/inforeqvalv.htm