Dexfenfluramine is a weight loss pill marketed with the brand name Redux. It is a serotonin reuptake inhibitor and releasing agent. Redux is actually dexfenfluramine hydrochloride. U.S. Food and Drug administration approved it in 1990 to be used for weight loss.
In 1997 FDA announced withdrawal of Dexfenfluramine from the market. It was a result many new evidence surfacing which linked use of dexfenfluramine with severe side effects such as Primary Pulmonary Hypertension. It asked Wyeth, a subsidiary of American Home products Corp, manufacturer of Dexfenfluramine drug Redux to voluntarily withdraw this drug from the market. Dexfenfluramine was manufactured for Interneuron Pharmaceuticals. Both companies agreed to voluntarily withdraw the drug Redux from the market.
Dexfenfluramine or Redux is a weight loss drug. It is used for treatment of obesity. It helps to reduce weight if taken along with a low calorie diet. This drug has been removed from market in U.S. by FDA due to safety concerns. It has been linked with heart problems including primary pulmonary hypertension.
The FDA action was a result of new findings from doctors who had evaluated patients taking this drug with echocardiograms. Echocardiogram is a procedure to test the functioning of heart valves. These findings pointed out that approximately 30 percent of patients who gone through this test had abnormal echocardiograms, even though they were not showing any symptoms. This is a much higher percentage of abnormal test results raising an alarm.
FDA asked patient using this drug to stop taking it immediately. Patients were advised to contact their doctors for alternative options of this drug for their treatment.
These studies linked dexfenfluramine with heart valve problems including primary pulmonary hypertension. Another dug Fen-phen was also banned along with Dexfenfluramine. Fen-phen was a combination drug containing fenfluramine. FDA has issued safety alerts related to fenfluramine earlier. Researchers at the Mayo Clinic and Mayo Foundation reported 24 cases of rare valvular disease in women using these drugs.
Later FDA received 66 additional reports of heart valve disease associated with these drugs. FDA requested that the manufacturers of dexfenfluramine should put more stress on the potential risk to the heart in the drug’s labeling and patient package inserts earlier. But even then FDA was continuously receiving the reports of adverse affects specially Primary Pulmonary hypertension associated with use of Dexfenfluramine.
Finally FDA had to call for a withdrawal of Dexfenfluramine from the market. Dexfenfluramine is linked with severe side effects such as Pulmonary Hypertension, Tachycardia, Convulsions, restlessness or excitement, Ventricular arrhythmia, breathing trouble and Valvular heart disease. Valvular heart diseases could result into primarily aortic regurgitation, hypertension, angina pectoris, palpitation, vasodilation and migraine.
Patients were advised to consult their doctor before using Dexfenfluramine. Patients having high blood pressure, lung diseases, liver diseases, hypertension, breathing problems, thyroid problems, Glaucoma or any allergy should consult their doctor before using Dexfenfluramine. It was advised to avoid its use in children. Patients were advised to be cautious while using this drug if you are an elderly person.
