Back in 1997, the US Food and Drug Administration (FDA) issued recommendations for patients who had taken fenfluramine or dexfenfluramine. Among the recommendations were that anyone who had taken those drugs—either on their own or in combination with other drugs—should have a complete medical history with a focus on the heart and lungs. Patients were then recommended to have an echocardiogram done to determine if there was any damage to the heart valves. The echocardiogram was considered mandatory if the physical exam found evidence of lung or heart disease but was also encouraged if patients were to undergo a medical or dental procedure that would involve the use of an antibiotic in certain patients to prevent infections.
At the time, the FDA noted that because the heart valve problems were newly recognized, there was no data on what happened to people over time. Symptoms of heart valve problems included shortness of breath, swelling in the legs, chest pain and/or heart palpitations.
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Fen-Phen was a combination of fenfluramine and phentermine, designed to help patients lose weight. According to a Morbidity and Mortality Weekly Report, issued by the Centers for Disease Control and Prevention (11/14/97), as of September 30, 1997, the FDA received 144 spontaneous reports of adverse events involving fenfluramine or dexfenfluramine. Of those, 113 were considered severe enough to include in the report. Of those 113 cases, 79 percent involved fen-phen (the combination of fenfluramine and phentermine). Of all 113 cases, 24 percent required cardiac valve-replacement surgery and of those three patients died following surgery.