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
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PONDIMIN AND REDUX TO BE VOLUNTARILY WITHDRAWN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.
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.
