It is a term used to refer to the combination of the drugs fenfluramine (Pondimin) and phentermine (Ionamin and Adipex-P). Serious medical complications have arisen in patients exposed to fenfluramine alone or in combination with phentermine. They have also been noted in patients receiving a related drug, dexfenfluramine (Redux). The use of fen phen (as a combination) was not approved by the Food and Drug Administration. Ongoing litigation related to damages from exposure to these drugs continues.
Risks:
Patients receiving fenfluramine alone, fenfluramine in combination with phentermine, or those receiving dexfenfluramine alone, have encountered a significantly increased risk for developing valvular heart disease (damage to heart valves), PPH (Primary Pulmonary Hypertension) and neuropsychological abnormalites.
Symptoms include dyspnea (shortness of breath), dizziness (weakness or fainting spells), chest pain, fatigue and edema (ankle swelling). The other category, known as neuropsychological damage, involves the development of memory loss, behavior changes, depression or mood swings, or psychotic symptoms.
Who Is At Risk?
The Food and Drug Administration requested that fenfluramine and dexfenfluramine be withdrawn from the market in September of 1997. Up to that time they had received more than 100 reports of adverse effects associated with the use of fen phen or one of the other agents alone (fenfluramine or dexfenfluramine). By 1996, an estimated 6 million Americans (mostly women and not all of them suffering from obesity) had taken fen phen. In 1996, 18 million prescriptions were written for the drug in the United States.
The Centers for Disease Control and Prevention have issued statistics related to the drug. According to the CDC, up to 30 % of people who have taken this combination may have heart valve defects. Unfortunately, patients who show evidence of these disorders often have no symptoms at the time of evaluation. Therefore, anyone who has taken these drugs should be evaluated by a physician.
Responsibility:
These drugs were widely prescribed by many physicians, even though the combination was not approved by the Food and Drug Administration. However, physicians were under the assumption that the individual drugs and the combination were safe. Wyeth, the manufacturer of fenfluramine and dexfenfluramine had knowledge that these drugs were associated with heart failure, the need for heart valve replacement and death. From 1989 to 1996 Wyeth reported that there were only four cases of PPH associated with the drug. The true figure was much higher. Sadly, most patients who used the drug successfully regained the weight they lost.
Recoverable Damages:
People with Primary Pulmonary Hypertension can seek to recover damages related to physical pain and suffering, medical expenses, loss of earnings and punitive damages. People with fen phen related valvular heart damage are eligible to participate in a national class action settlement. Those suffering from Primary Pulmonary Hypertension or neuropsychological damage must pursue individual claims through attorneys who handle this type of litigation.
