(IRVINE,
Calif., January 11, 2005) –
Last month, federal and state
investigators concluded that Allergan,
Inc.’s BOTOX® (botulinum
toxin type A) was not involved
in the cases of four patients
suffering from botulism after
receiving treatment at a clinic
in Fort Lauderdale, Florida. The
U.S. Food and Drug Administration
(FDA), in collaboration with The
Centers for Disease Control (CDC),
continues as the lead responsible
Agency for the ongoing investigation
which has determined that these
botulism cases resulted from the
illegal administration, by an
unlicensed physician, of extremely
large and irregular amounts of
an unlicensed and unapproved botulinum
toxin obtained from a Northern
California maker of raw research
material. Although BOTOX®
is not involved in this ongoing
investigation, Allergan continues
to provide assistance to authorities
wherever possible. Fortunately,
no additional cases of botulism
related to the use of unlicensed
and unapproved botulinum toxin
have been reported to date.
In response to published
comments of a director of the
Palm Beach County Health Department,
Douglas S. Ingram, Allergan’s
Executive Vice President, said,
“There is no question that
the use of unlicensed and unapproved
botulinum toxin is unlawful and
dangerous. We have worked closely
with the Florida Department of
Health in investigating the isolated
case of an unlicensed doctor in
Florida using an unapproved bulk
toxin and wholeheartedly support
efforts to prevent this unlawful
practice from continuing in the
future.”
Ingram continued,
“However, halting the use
of BOTOX® and BOTOX® Cosmetic
in South Florida is unnecessary
and inappropriate. This investigation
does not involve BOTOX® and
it is not an issue of an unsuspecting
health care practitioner getting
something other than BOTOX®.
The issue of unsafe alternatives
to BOTOX® involves unethical
health care professionals who,
for reasons of greed and total
disregard for their patients’
well-being, knowingly choose to
use unlicensed, unapproved and
dangerous products, rather than
a real medicine, BOTOX®. Physicians
and patients are able to confirm
whether they are receiving authentic
BOTOX® and BOTOX® Cosmetic
prior to treatment by 1.) visiting
only reputable and licensed physicians;
and 2.) inspecting the vial of
BOTOX® to be used to confirm
that it displays the BOTOX®
trademark and Allergan’s
unique hologram.”
BOTOX® has been
used for over 15 years to treat
millions of patients worldwide
for serious or debilitating neurological
disorders. In addition, BOTOX®
has a 15-year manufacturing history
with rigorous quality control
and quality assurance processes
that are overseen by numerous
health authorities worldwide.
Physicians and patients should
continue to feel confident in
the heritage and safety record
of authentic BOTOX® and BOTOX®
Cosmetic.
To ensure receipt
of authentic BOTOX® and BOTOX®
Cosmetic, physicians and patients
should know that:
· BOTOX®
distributed under the
names BOTOX® and BOTOX®
Cosmetic is the only licensed
and FDA-approved botulinum toxin
type A product available in the
United States.
· Only licensed
and skilled physicians should
inject BOTOX® and BOTOX®
Cosmetic. Optimal results are
achieved when BOTOX® is administered
by a well-trained physician with
extensive knowledge of the product
and the area of injection, and
who has the qualifications necessary
to evaluate and determine the
best treatment for each individual.
· Allergan
has a number of measures in place
to ensure the integrity and authenticity
of BOTOX® and BOTOX® Cosmetic,
including a state-of-the-art holographic
marking on each vial that is easy
to inspect.
· Patients
should always verify with their
physicians that they are receiving
authentic BOTOX® or BOTOX®
Cosmetic and not an unlicensed
botulinum toxin.
· Licensed
products available in the U.S.
can be verified by checking with
the FDA’s web site at www.fda.gov.
Physicians and consumers with
questions may also call 1-800-433-8871
to speak to a company representative
if they are unsure a product is
the licensed and approved BOTOX®
product.
Allergan encourages
both physicians and consumers
to visit its web sites at www.Allergan.com,
www.BOTOX.com and www.BOTOXCosmetic.com
to learn more about BOTOX®
and BOTOX® Cosmetic.
About Allergan,
Inc.
Allergan, Inc.,
with headquarters in Irvine, California,
is a technology-driven, global
health care company providing
specialty pharmaceutical products
worldwide. Allergan develops and
commercializes products in the
eye care, neuromodulator, skin
care and other specialty markets
that deliver value to its customers,
satisfy unmet medical needs, and
improve patients’ lives.
Allergan Contacts:
Jim Hindman (714)
246-4636 (investors)
Joann Bradley (714)
246-4766 (investors)
Ashwin Agarwal (714)
246-4582 (investors)
Caroline Van Hove
(714) 246-5134 (media)
Stephanie Fagan
(714) 246-5232 (media)
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