Primary Pulmonary Hypertension & PPH - Find a Lawyer to file a Fen Phen Lawsuit

Another FDA Official Testifies in PPH Lawsuit

Dr. Janet Arrowsmith-Lowe, M.D., F.A.C.P., offered the following expert report on Wyeth’s behalf in the case of Wright v. American Home Products.

C. FDA Approvals of Pondimin and Redux

I agree with the FDA that the NDA data for Pondimin and Redux supported a conclusion that the drugs were safe and effective when used in accordance with their labeling. In other words, the potential benefits outweighed the known risks. My opinions on the adequacy of the data and labeling are based on my reviews of NDA data, FDA's reviews of the data, and my experience with the FDA review processes.

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.

Former FDA Official Discusses Fen-Phen in PPH Lawsuit

Dr. David Feigal, Jr., M.D., M.P.H., filed the following expert witness report in the case of Wright v. American Home Products:

Information on pulmonary hypertension was added to the “Precautions” section of the Pondimin label in 1983. In 1987 a revision in the labeling expanded on the information regarding pulmonary hypertension warning that a fatality had occurred. At all times, up to the 1996 revision, information on pulmonary hypertension was appropriately placed in the “Precautions” section as required by the FDA's labeling regulations. This placement communicated to physicians that based on the available information, pulmonary hypertension might be associated with use of the drug. Prior to the Pondimin labeling revisions in 1996 the labeling contained an outdated reference to the number of pulmonary hypertension reports that had been received for patients taking Pondimin. However, the fact that the number of cases was not updated did not render the labeling inadequate. Rather, the label continued to apprise physicians of the known risks involved. Wyeth revised the label in 1996, to add information in the “Warnings” section, derived from the IPPHS. The IPPHS provided Wyeth and the FDA with new information about the risks with PPH in patients taking appetite suppressants.

A review of FDA documents illustrates that Agency did not find it necessary to add any additional information concerning pulmonary hypertension to the Pondimin and Redux labeling until the conclusion of the IPPHS. When the FDA reviewed the labeling in 1994 it determined that the labeling did not require any changes at that time, despite acknowledging that there had be reports of more than 4 case of pulmonary hypertension as mentioned in the labeling. Following the release of the IPPHS results, FDA determined that the results should be displayed on the Redux label. Following the revision to the Redux label the FDA decided to address changes to the Pondimin label. The FDA and Wyeth agreed that instead of listing the number of case reports of pulmonary hypertension, the Pondimin and Redux labels should provide a relative risk calculation based on the IPPHS