Report Filed By Expert Witness For Wyeth Defends Warning Label For Redux

The central issue in any fen-phen pph lawsuit is whether the manufacturer adequately warned the public of the risks of PPH when taking fen-phen.  The expert witness in this case believes Wyeth did:

The FDA determined that the data submitted for Pondimin established the safety and
efficacy of the drug for short-term use as adjunctive therapy for the treatment of
obesity. Pondimin was found to have a lower abuse potential than amphetamine-like
drugs, which for many years had been used widely as appetite suppressants.

The Redux NDA contained extensive information on safety and effectiveness. This
included years of widespread use in Europe where it had been marketed since the
mid-1980s. Included in the NDA were controlled clinical trials of up to one year
duration demonstrating safety and effectiveness, as well as detailed
post-marketing safety reports. The studies demonstrated that dexfenfluramine was
more effective than placebo in promoting weight loss, when administered to
patients with instructions regarding diet and activity.

Also included in the Redux NDA were results from the International Primary
Pulmonary Hypertension Study (IPPHS), which addressed the risk associated with
anorexigen drug exposure in the development of primary pulmonary hypertension
(PPH). The FDA also convened an Advisory Committee to review the safety and
effectiveness of Redux, including data relating to PPH. The FDA was well apprised
of the risk of PPH in patients who took Redux and Pondimin before the NDA was
approved. After reviewing the data on PPH and the IPPHS, as well as the
post-marketing safety data from Europe, the Advisory Committee recommended the
approval of Redux based on a favorable risk-benefit ratio. FDA approved the drug
for marketing in the United States in April 1996. In my opinion, the initial Redux
labeling adequately and appropriately conveyed the safety data learned in both the
pre-approval studies and the European post-marketing experience with
dexfenfluramine.