Redux (dexfenfluramine)

Redux (dexfenfluramine) is an oral medication used in the treatment of obesity. It helps promote and manage weight loss in persons on a reduced calorie diet. Manufactured by American Home Products Corporation, Redux is designed to increase the level of the neurotransmitter serotonin. Serotonin depresses the central nervous system, regulating mood and appetite. The end result is a feeling of fullness and loss of appetite.

Why Prescribed

Redux is prescribed for the management of obesity in adults and for the maintenance of weight loss.

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FDA Approved Uses

Redux was approved for use by the FDA in 1996 as an appetite suppressant in the management of obesity.

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Side Effects

Side effects associated with Redux use include drowsiness, diarrhea, gas, nausea, headache, dry mouth, runny nose, sweating, altered sense of taste, constipation, heartburn, anxiety, insomnia and depression.

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Warnings and Alerts

Redux (dexfenfluramine) was withdrawn by the FDA from the U.S. market in 1997 after reports of heart valve disease and pulmonary hypertension, including a condition known as cardiac fibrosis, was connected with its use. In addition to heart valve disease, the use of Redux has been found to increase the risk of developing Primary Pulmonary Hypertension or PPH. PPH is a rare disease that causes the progressive narrowing of the blood vessels of the lungs.

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Drug Contraindications

Redux should not be used in patients with hypersensitivity to dexfenfluramine or related compounds or in patients with diagnosed pulmonary hypertension. Redux should not be used concurrently with an MAO inhibitor or within 14 days of discontinuation, and should not be taken in combination with other selective serotonin reuptake inhibitors.

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FAQ's

What is pulmonary hypertension?

Pulmonary hypertension is an elevated blood pressure in the lungs. When the resistance to blood flow in the lungs goes up, the pressure in the pulmonary arteries also increases. The presence of pulmonary hypertension indicates either high blood flow, high resistance, or both. If left untreated, this can lead to heart failure, cyanosis, and eventually serious consequences including death.

What is the evidence that prompted withdrawal of Redux?

On July 8, 1997, the Mayo Clinic reported 24 patients developed heart valve disease after taking Redux. In five patients who underwent valve replacement surgery, the diseased valves were found to have distinctive features similar to those seen in carcinoid syndrome. The cluster of unusual cases of valve disease in Redux users suggested that there might be an association between Redux use and valve disease.

On July 8, 1997, the FDA issued a Public Health Advisory that described the Mayo findings. The FDA has since received thousands of reports (including the original 24 Mayo cases) of heart valve disease associated with Redux. Based on these data, American Home Products Corporation agreed to withdraw the product from the market.

What is the difference between fenfluramine and dexfenfluramine?

Fenfluramine, also known as Pondimin, contains dexfenfluramine and levofenfluramine. Levofenfluramine may have some activities not directly related to appetite suppression. Dexfenfluramine (Redux) contains only dexfenfluramine.

Has there been any legal action initiated against the manufacturer of Redux?

Yes. American Home Products Corporation has agreed to a settlement in which the company will compensate injured victims a total of approximately $12 billion. The amount an injured individual receives depends upon the severity of the individual's heart valve disorder and the age at which the individual was prescribed Redux. Individual damage awards range from several thousands of dollars to $1.5 million.

Can I file a lawsuit if I have been injured as the result of taking Redux?

Patients injured by unsafe products are ordinarily entitled to recover monetary damages for all losses and expenses suffered from use of the product. Depending upon the particular circumstances of your case, damages may include recovery for any of the

• Past and future medical expenses
• Past and future pain and suffering
• Lost wages
• Loss of future earning capacity
• Emotional distress

If you have suffered injuries such as PPH from using Redux, or have lost a loved one due to wrongful death from using Redux, you have legal rights and should contact a qualified defective drug litigation attorney to discuss your legal claim. As all legal claims are subject to time limits, known as statute of limitations, you may risk forfeiture of your right to financial compensation if you delay.

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