SOURCE [1] Skinlastin Experiencing Rising Sales Amid Recent FDA Botox Warning
www.prweb.com December 27, 2008 [2] Using Botox To Cure Migranes ozarksfirst.com Dec 23,
2008 [3] Top 10 Biggest Medical Stories of 2008 www.attorneyatlaw.com  January 3, 2009
Botox
January 3, 2009
NEWS
December 2008 FDA warning issued in early February of 2008--
have advised consumers of newly learned risks that are associated
with using the popular injections, Botox. Of the risks, dangerous
side effects such as respiratory failure and death have been
warned of by the FDA. This report has spurred the sales of other
anti-wrinkle creams like Skinlastin. [1]

The common side effects include the loss of facial expressiveness,
and the numbing or losing of feeling in the muscles of areas near to
where injections have been administered. Fatal side effects are
rare but serious including respiratory failure and death. [1]

Off-label Uses of Botox
However, a study done at the Headache Care Center, which was
recently published, found that patients who were unsuccessful with
more traditional treatments were given back their quality of life, with
Botox. Patients get multiple injections at specific points in their
forehead, neck and other muscles. Doctors say the results typically
last 3 to 4 months, unlike other medications taken on a daily basis.
Please, note that FDA hasn't approved Botox for treatment of
Migraines. [2]

Some physicians used Botox to stop muscle rigidity and spasms in
cerebral palsy patients, but the powerful drug can migrate inside
the body and affect the muscles that control breathing, causing
death. In July 2008, a lawsuit was filed against Allergan Inc., Botox’s
maker, on behalf of the families of deceased victims and other
victims, alleging the company promoted “off label” uses of Botox,
causing injuries and deaths. [3]
Early Communication about an Ongoing Safety Review Botox and Botox Cosmetic
(Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) FDA February 8,
2008

FDA has received reports of systemic adverse reactions including respiratory
compromise and death following the use of botulinum toxins types A and B for both
FDA-approved and unapproved uses. The reactions reported are suggestive of
botulism, which occurs when botulinum toxin spreads in the body beyond the site
where it was injected. The most serious cases had outcomes that included
hospitalization and death, and occurred mostly in children treated for cerebral palsy-
associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity
(severe arm and leg muscle spasms) in children or adults is not an approved use in
the U.S.

These serious systemic adverse reactions occurred following treatment of a variety
of conditions using a wide range of botulinum toxin doses.  FDA is currently
reviewing safety data from clinical studies submitted by the manufacturers of Botox,
Botox Cosmetic and Myobloc, as well as post-marketing adverse event reports and
the medical literature.

Botox (botulinum toxin type A) is approved for treatment of conditions such as
blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle
spasms), and severe primary axillary hyperhydrosis (excess sweating).  Botox
Cosmetic, also botulinum toxin Type A, is approved for temporary improvement in the
appearance of moderate to severe facial frown lines.

Myobloc (botulinum toxin Type B) is approved for the treatment of adults with cervical
dystonia; the safety and effectiveness of Myobloc for cervical dystonia in children have
not been established.   

FDA is aware of the body of literature describing the use of botulinum toxins to treat
limb spasticity in children and adults.  The safety, efficacy and dosage of botulinum
toxins have not been established for the treatment of limb spasticity of cerebral palsy
or for use in any condition in children less than 12 years of age.

The current prescribing information (labeling) for  Botox,  Botox Cosmetic and
Myobloc describes adverse reactions occurring in regions near the site of injection
for each product’s approved uses, such as dysphagia (difficulty swallowing) after
injections to treat cervical dystonia, or ptosis (drooping eye lids) after injections for
glabellar frown lines or for strabismus and blepharospasm.

The Warnings sections of the labeling for both botulinum toxin products note that
important systemic adverse effects, including severe difficulty swallowing and
difficulty breathing have occurred in patients with neuromuscular disorders after local
injection of typical doses of botulinum toxin.  FDA now has evidence that similar,
potentially life-threatening systemic toxicity from the use of botulinum toxin products
can also result after local injection in patients with other underlying conditions such
as those with cerebral palsy associated limb spasticity. Systemic toxicity has been
reported in children, several of whom required feeding tubes and/or ventilation
(breathing) support.

Until such time that FDA has completed its review, healthcare professionals who
use medicinal botulinum toxins should:   

* Understand that potency determinations expressed in “Units” or “U” are different
among the botulinum toxin products; clinical doses expressed in units are not
comparable from one botulinum product to the next
* Be alert to the potential for systemic effects following administration of botulinum
toxins such as: dysphagia, dysphonia, weakness, dyspnea or respiratory distress
* Understand that these effects have been reported as early as one day and as late
as several weeks after treatment
* Provide patients and caregivers with the information they need to be able to identify
the signs and symptoms of systemic effects after receiving an injection of a
botulinum toxin
* Tell patients they should receive immediate medical attention if they have
worsening or unexpected difficulty swallowing or talking, trouble breathing, or muscle
weakness

What does FDA know now about these data?

The FDA has reviewed post-marketing cases from its Adverse Event Reporting
System (AERS) database and from the medical literature of pediatric and adult
patients diagnosed with botulism following a local injection with a marketed
botulinum toxin product.

The pediatric botulism cases occurred in patients less than 16 years old, with
reported symptoms ranging from dysphagia to respiratory insufficiency requiring
gastric feeding tubes and ventilatory support.  Serious outcomes included
hospitalization and death.  The most commonly reported use of botulinum toxin
among these cases was treatment of limb muscle spasticity associated with
cerebral palsy.  For Botox, doses ranged from 6.25 to 32 Units/kilogram (U/kg) in
these cases.  For Myobloc, reported doses were from 388 to 625 U/kg.

The reports of adult botulism cases described symptoms including patients
experiencing difficulty holding up their heads, dysphagia and ptosis.  Some reports
described systemic effects that occurred distant from the site of injection and
included weakness and numbness of the lower extremities.  Among the adult cases
that were serious, including hospitalization, none required intubation or ventilatory
support. No deaths were reported.  The doses for Botox ranged from 100 to 700
Units and for Myobloc from 10,000 to 20,000 U.


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