-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, URTEuVPhOLIV6T23rsnL5vQn2uqIHF+OcClILlEhE5o8WEPnTu/TduyH8LfbbOQF JA8+E9XpMtyyUiGA5JmhKQ== 0000005187-97-000010.txt : 19970918 0000005187-97-000010.hdr.sgml : 19970918 ACCESSION NUMBER: 0000005187-97-000010 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 19970915 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 19970915 SROS: NYSE FILER: COMPANY DATA: COMPANY CONFORMED NAME: AMERICAN HOME PRODUCTS CORP CENTRAL INDEX KEY: 0000005187 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 132526821 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 001-01225 FILM NUMBER: 97680639 BUSINESS ADDRESS: STREET 1: 5 GIRALDA FARMS CITY: MADISON STATE: NJ ZIP: 07940 BUSINESS PHONE: 201-660-50 8-K 1 SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported) September 15, 1997 AMERICAN HOME PRODUCTS CORPORATION (Exact name of registrant as specified in its charter) Delaware 1-1225 13-2526821 (State or other jurisdiction (Commission (I.R.S. Employer of incorporation or File Number) Identification organization) Number) Five Giralda Farms, Madison, New Jersey 07940 (Address of Principal Executive Offices) (Zip Code) Registrant's telephone number, including area code (973)660-5000 Not Applicable (Former name or address, if changed since last report) Item 5. Other Events Incorporated by reference are two press releases issued September 15, 1997 concerning the Registrant's announcement of the voluntary market withdrawal of dexfenfluramine marketed under the name Redux by the Registrant's Wyeth-Ayerst Laboratories division ("Wyeth-Ayerst"), and fenfluramine, manufactured and marketed by Wyeth-Ayerst under the name Pondimin. Item 7. Financial Statements and Exhibits (c) The following exhibits are filed herewith: Exhibit 99.1 - Press release issued September 15, 1997 Exhibit 99.2 - Press release issued September 15, 1997 SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on behalf by the undersigned thereunto duly authorized. AMERICAN HOME PRODUCTS CORPORATION By: /s/ Paul J. Jones Paul J. Jones Vice President and Comptroller Date: September 15, 1997 EX-99.1 2 Contact: Wyeth-Ayerst Laboratories Audrey Ashby (610) 971-5823 Doug Petkus (610) 971-4980 Robinson Lerer & Montgomery Michael Bulger (212) 484-7413 PONDIMIN AND REDUX TO BE VOLUNTARILY WITHDRAWN Action Is Based on New Information Company Says It Is Taking the Most Prudent Course of Action for Patients and Doctors Company Will Form Expert Panel to Review All Data PHILADELPHIA, PA -- September 15, 1997 -- Wyeth-Ayerst Laboratories, a division of American Home Products Corporation (NYSE:AHP), the manufacturer of PONDIMIN (fenfluramine hydrochloride) tablets C-IV and the distributor of REDUX (dexfenfluramine hydrochloride capsules) C-IV, today announced a voluntary and immediate withdrawal of these weight loss medications. The company is taking this action on the basis of new, preliminary information regarding heart valve abnormalities in patients using these medications. Our first commitment is to our patients and to their doctors, said Marc W. Deitch, M.D., Senior Vice President Medical Affairs, Global Medical Director. Even though this new information is not derived from a thorough clinical study and is difficult to evaluate, the company is taking the most prudent course of action. Wyeth-Ayerst is committed to safeguarding the health and well-being of patients and ensuring that health care providers have the latest medical information. Owing to the unanswered questions prompted by the emerging findings, the company today also announced that it is forming an expert panel of leading physicians and researchers to thoroughly evaluate the data and recommend additional actions to address this situation. The company will work closely with this panel, as well as with the U.S. Food and Drug Administration (FDA), to better understand these findings. Patients who have used either of these products should contact their physicians. A full-page notice will appear in leading national and regional newspapers announcing this decision and providing a toll-free telephone number (1-800-892-2718) for those requiring further information. In addition, the company has sent notification of this action to approximately 450,000 physicians and pharmacists nationwide. The company will also offer an opportunity to return unused product. Based on postmarketing reports from the Mayo Clinic of 24 cases of heart valve disease in some patients treated with the combination of phentermine and fenfluramine, the company advised health care providers in a July 24, 1997, letter of the addition of boxed warnings concerning heart valve disease to the labeling for Pondimin and Redux. The company also announced a joint effort with the Mayo Clinic to initiate a comprehensive study to examine the possible association of unusual valvular disorders with these products. The Mayo Clinic cases were subsequently reported in an article appearing in the August 28, 1997, issue of The New England Journal of Medicine. This article was accompanied by a letter to the editor from the FDA reporting additional cases of heart valve disease in 28 patients taking the combination of phentermine and fenfluramine, two patients taking fenfluramine alone, four patients taking dexfenfluramine alone, and two patients taking dexfenfluramine and phentermine. Additional adverse event reports of abnormal heart valve findings in patients using dexfenfluramine or fenfluramine alone or in combination with other weight loss agents continue to be received by the company and the FDA. These reports have included shortness of breath, chest pain, fainting, swelling of the ankles or a new heart murmur. On Friday afternoon, September 12, 1997, the FDA provided Wyeth-Ayerst with new summary information concerning abnormal echocardiogram findings in asymptomatic patients seen in five centers. These patients had been treated with fenfluramine or dexfenfluramine for up to 24 months, most often in combination with phentermine. Abnormal echocardiogram findings were reported in 92 of 291 subjects evaluated, including 80 reports of aortic regurgitation (mild or greater) and 23 reports of mitral regurgitation (moderate or greater). These observations reflect a preliminary analysis of pooled information rather than results of a formal clinical investigation, and are difficult to evaluate because of the absence of matched controls and pretreatment baseline data for these patients. Nevertheless, the company believes it is prudent, in light of this information, to withdraw these products from the market at this time. Wyeth-Ayerst Laboratories, a division of American Home Products Corporation (NYSE:AHP), is a major research-oriented pharmaceutical company. Full prescribing information available upon request. EX-99.2 3 FOR IMMEDIATE RELEASE Investor Contact: Media Contact: Thomas G. Cavanagh Lowell B. Weiner, Ph.D. (973) 660-5706 (973) 660-5013 VOLUNTARY RECALL OF PONDIMIN AND REDUX TO IMPACT EARNINGS FOR 1997 AND 1998 Madison, NJ, September 15, 1997 -- American Home Products Corporation (NYSE:AHP), following this morning's announcement of its voluntary recall of Pondimin and Redux, commented on the impact on earnings for 1997 and 1998. The Company's estimates of the profit loss related to lost sales of these products is approximately 2 cents in both the third and fourth quarters 1997 and 10 cents for 1998. The one time cost of the product withdrawal is estimated to be between $200 and $300 million or 20 cents to 30 cents per share after tax. The Company is a party to a number of legal actions, some of which are purported class actions, involving valvular disorders with respect to the use of Pondimin and/or Redux. It is likely that additional legal actions, including purported class actions, will be filed. At this time it is not possible to determine the extent of claims which may be made with respect to these products. Additional charges may be recorded depending on further developments. The statements in this release that are not historical facts are forward- looking statements that involve risks and uncertainties, as detailed from time to time in AHP's periodic reports, including quarterly reports on Form 10-Q and the annual report on Form 10-K, filed with the Securities and Exchange Commission. Actual results may differ from the forward-looking statements. American Home Products is one of the world's largest research-based pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of prescription drugs and over-the-counter medications. It is also a global leader in vaccines, biotechnology, agricultural products, animal health care and medical devices. -----END PRIVACY-ENHANCED MESSAGE-----