The phen/fen problem/recall is not an off label use issue. It solely a problem for the FDA approved Redux, dexfenflouamine (alone) and FDA approved Pondimin, fenflouramine (alone). The off label combo arguement was just a red herring to delay or prevent the recall.
Here's an article that breaks down the EKG problem. Most of the patients
271/291 has been on phen/fen, 14 had been on phen/Redux, and 6 had been on
Redux alone. Overall 30% showed an abnormal EKC including 33% (2 of 6) of the
patients just taking Redux (A similar per cent, 4 of 14, was found with phen/Redux).
Numbers for Redux are small, but percentage is consistant with the much larger
number and independent of the phen combo. Thus, the off label combo had nothing to
do with the abnormal EKG found in the 30% of patients taking some form of
fenflouramine:
Redux To Be Voluntarily Withdrawn; Pondimin Also
To Be Withdrawn
Business Wire - September 15, 1997 08:00
INTERNEURON IPIC %MASSACHUSETTS %MEDICINE
%PHARMACEUTICAL
%BIOTECHNOLOGY V%BW P%BW
Jump to first matched term
LEXINGTON, Mass.--(BW HealthWire)--Sept. 15, 1997--
Actions Are Based on New Information; Company Says
It Is Taking the Most Prudent Course of
Action for Patients and Doctors
Interneuron Pharmaceuticals, Inc. (NASDAQ:IPIC) and Wyeth-Ayerst Laboratories
today
announced a voluntary and immediate withdrawal of the weight loss medication Redux
(dexfenfluramine hydrochloride capsules) C-IV. Simultaneously, Wyeth-Ayerst
announced
withdrawal of the weight loss medication Pondimin (fenfluramine hydrochloride) tablets
C-IV.
The companies are taking this action based on new, preliminary information regarding
heart
valve abnormalities in patients using these medications, most often in combination with
phentermine, another weight loss medication. Although this information is not derived
from a
thorough clinical study and is difficult to evaluate, the Company is taking what it
believes is the
most prudent course of action. The Company is committed to safeguarding the health
and
well-being of patients and ensuring that health care providers have the latest medical
information.
Patients who have used either Redux or Pondimin should contact their physicians.
Wyeth-Ayerst will be placing a full-page notice in leading national and regional
newspapers
announcing this decision and providing a toll-free telephone number
(1-800-892-2718) for
patients requiring further information.
In addition, Wyeth-Ayerst has sent notification of this action to approximately 450,000
physicians and pharmacists nationwide and will also offer an opportunity to return
unused
product. Owing to the unanswered questions prompted by the emerging findings,
Wyeth-Ayerst 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. Interneuron will work closely with this panel, as well as with the U.S.
Food and
Drug Administration (FDA), to better understand this new information.
Based on postmarketing reports from the Mayo Clinic of 24 cases of heart valve
disease in
patients treated with the combination of phentermine and fenfluramine, Wyeth-Ayerst
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. Wyeth-Ayerst has 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 companies and the FDA. These reports have included symptoms
such
as shortness of breath, chest pain, fainting, swelling of the ankles or a new heart
murmur.
Most recently, on Friday afternoon, September 12, 1997, the FDA provided the
companies
with new summary information concerning abnormal echocardiogram findings in
patients with
no symptoms of heart valve disease. These patients had been treated with fenfluramine
or
dexfenfluramine for up to 24 months, most often in combination with phentermine.
Redux was
launched in June 1996. Abnormal echocardiogram findings were reported in 92 of 291
subjects evaluated. Two hundred and seventy-one of the 291 patients had taken
fenfluramine
in combination with phentermine, and 20 of the 291 patients had taken dexfenfluramine
or a
combination of dexfenfluramine and phentermine. Of these 20, six had abnormal
echocardiograms, and two of the six took Redux alone.
The abnormal echocardiogram findings included 80 reports of aortic regurgitation (mild
or
greater), four of which occurred in patients taking Redux alone or in combination with
phentermine, and 23 reports of mitral regurgitation (moderate or greater), two of which
occurred in patients taking Redux alone or in combination with phentermine.
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, Interneuron
believes
it is prudent, in light of this information, to withdraw Redux from the market at this time.
In connection with the withdrawal of Redux, the Company anticipates taking charges
to
operations in its fourth quarter and fiscal year ending September 30, 1997, for
expenses
related to the discontinuation of the operations related to Redux. Based on preliminary
estimates, the Company anticipates these charges will be in the range of $8 million to
$12
million. A significant portion of Interneuron's revenues has been derived from Redux
sales.
The Company anticipates that it will not incur certain previously planned expenses
related to
the development of a once-a-day formulation and other activities relating to Redux.
Interneuron has been named, together with other pharmaceutical companies, as a
defendant in
a number of legal actions involving the use of Redux and other weight loss drugs. The
withdrawal of Redux and related events may materially adversely affect the Company
and its
financial condition.
Interneuron Pharmaceuticals is a diversified biopharmaceutical company engaged in the
development and commercialization of a portfolio of products and product candidates
primarily for neurological and behavioral disorders. Redux was licensed to Interneuron
in the
U.S. by Les Laboratoires Servier, a French pharmaceutical company, and sublicensed
by
Interneuron to Wyeth-Ayerst Laboratories, a division of American Home Products
Corporation. Interneuron is also developing products and technologies, generally
outside the
central nervous system field, through four subsidiaries: Intercardia, Inc. focused on
cardiovascular disease, Progenitor, Inc. focused on developmental genomics, Transcell
Technologies, Inc. focused on carbohydrate-based drug discovery, and InterNutria,
Inc.
focused on dietary supplement products.
Except for the descriptions of historical facts contained herein, this press release
contains
forward-looking statements that involve risks and uncertainties as detailed from time to
time in
the Company's filings under the Securities Act of 1933 and the Securities Exchange
Act of
1934, including in particular, risks relating to the withdrawal of Redux, such as safety
and
regulatory, product liability, litigation, contractual obligations, uncertainties relating to
clinical
trials and other risks.
CONTACT: Interneuron Pharmaceuticals, Inc.
William B. Boni, 617/402-3410 |
