Redux
Pondimin Recall

Marketed under the names Redux and Pondimin, the fen phen claims deadline has been set for August 2002. The settlement is the result of Fen Phen and Redux users that have suffered serious and deadly cases of a condition called primary pulmonary hypertension (PPH) and other cardiovascular complications. The health complications that have ensued have been directly linked to the use of Fen Phen, marketed under Redux, Pondimin, Fenfluramine, and Dexfenfluramine that have led to a class action and numerous individual lawsuits.

If you would like to learn more about your legal rights regarding the Redux/ Pondimin recall, please contact us.

Public Citizen Sues the FDA Regarding Redux Research
On January 14, 1998, consumer group, Public Citizen, sued the FDA to release research protocol for banned diet drug Redux. The lawsuit asks that the FDA be required to release the research protocol for the Phase IV, or post-marketing safety study, for Redux. This action follows the FDA’s failed action to provide the information after Public Citizen requested it on August 21, 1997 under the Freedom of Information Act.

Redux and Pondimin Recalled
On September 15, 1997, the FDA announced that they were withdrawing dexfenfluramine and fenfluramine, marketed under the name Redux and Pondimin.

This action was based on post marketing reports from the Mayo Clinic of 24 cases of heart valve disease in some patients that were treated with the combination of phentermine and fenfluramine.

Boxed warnings were added to Redux and Pondimin labeling on July 25, 1997, prior to the recall to warn of the concern for possible heart valve disease. Additional adverse Redux and Pondimin heart valve findings were also found to occur. Cases of heart disease and heart damage are continuing to surface because of the delayed diagnoses that can often result because of the non-evident symptoms.

Redux Timeline
May 1993- Interneuron Pharmaceuticals Inc. files a New Drug Application (NDA) with the Food and Drug Administration.
Dec. 1993- Neuroscientists write the FDA with their concerns, based on animal studies, over the possibility of neurotoxicity in humans.
Sept. 1995- FDA advisory committee votes 5-3 not to recommend approval because of concerns over primary pulmonary hypertension and possible neurotoxicity.
Nov. 1995- In a highly unusual move, the FDA convenes a second advisory committee, this time voting 6-5 for approval.
Dec. 1995- Neuroscientists again contact the FDA to express concern about the drug’s potential to cause neurotoxicity in humans.
April 1996- Public Citizen urges the FDA to delay approval until the potential for neurotoxicity in humans can be assessed.
The FDA clears Redux for marketing.
Aug. 1996- The International Primary Pulmonary Hypertension Trial is published in the New England Journal of Medicine showing that the risk of primary pulmonary hypertension increases 23 times when Redux or other diet drugs are used for longer than three months.
July 1997- Mayo Clinic doctors announce they have identified 24 women who used diet drugs and developed heart valve damage.
FDA issues Public Health Advisory about heart valve damage.
Aug. 1997- Wyeth-Ayerst Laboratories announces agreement on the Redux Phase IV study protocol with the FDA. A major review of Redux neurotoxicity in animals is published in the Journal of the American Medical Association.
Mayo Clinic study is published in the New England Journal of Medicine.
Sept. 1997- Redux is withdrawn from the market.