Fen-Phen, banned by the U.S. Food and Drug Administration (FDA) in 1997, is a mixture of two obesity drugs, fenfluramine and phentermine, used to promote dramatic weight loss in obese people. In the late 1990s, the Mayo Clinic reported severe complications resulting in permanent heart and valvular damage, reported in 30 percent of Fen-Phen users. Fen-Phen also has other side effects that affect the nervous system, stomach and eyes.
Side Effects
Fen-Phen's severe side effects include valvular heart disease and primary pulmonary hypertension. Fen-Phen damages the valves that keep blood flowing into and out of the heart, disrupting blood flow. According to the American Heart Association, valvular heart disease causes around 20,000 deaths per year.
Other side effects associated with Fen-Phen are dry mouth, drowsiness, dizziness, confusion, abnormal blood pressure, mood instability and tremor. Vision-related side effects include blurred vision, pain around the eye and eye irritation. Stomach-related side effects include abdominal pain, nausea and cramping. Fen-Phen is also very addictive.
Significance
One hundred people reported significant valvular issues to the FDA in 1997 after taking Fen-Phen. Fen-Phen was officially removed from public sale by the FDA in the same year. People began filing lawsuits in 1997, citing long-term irreparable damage. In 2005, "The New York Times" reported Wyeth, the manufacturer of Fen-Phen, paid over $21 million to victims. Wyeth is still settling lawsuits today.
Features
According to the FDA, Fen-Phen's most reported side effect, heart valvular disease, has very little or no noticeable side effects. Since heart valvular disease usually develops slowly, the symptoms are not immediately noticeable. If heart valvular disease develops quickly, symptoms that develop include heart palpitations, edema and dizziness.
Treatment
Fen-Phen's most severe side effect, heart valvular disease, is managed through various medications, including angiotensin-converting enzyme (ACE) inhibitors and anti-arrhythmics. If the damage is severe, surgery is used to correct the heart valve. In rare instances, the heart valve is replaced in open heart surgery.
Misconceptions
Many people believe Fen-Phen's side effects are only present in women--most of the reported cases of heart valve damage came from women. The FDA says this is because Fen-Phen was mostly used by women, not because the side effects only affected women. Men are also at risk for developing serious complications.
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