Botox Warning
Botulinum Toxins Linked to Respiratory Failure and Death
NEW YORK, NY -- February 8, 2008 -- Botulinum toxin Type A
(Botox and Botox Cosmetic) and botulinum toxin Type B (Myobloc)
have been linked to serious adverse reactions, including
respiratory failure and death. The most severe adverse effects
were found in paediatric patients treated for limb spasticity
associated with cerebral palsy.
The adverse reactions mimic symptoms of botulism, including
difficulty swallowing, weakness, and breathing problems, and
appear to be related to the spread of the toxin to areas distant
from the injection site. The US Food and Drug Administration is
conducting an ongoing safety review. Early findings suggest
overdosing may be contributing to the adverse reactions.
The adverse effects occurred following treatment for both
FDA-approved and nonapproved indications. In the United States,
botulinum toxins are not approved for the treatment of limb
spasticity in children or adults, though the FDA is aware of the
body of literature describing this use.
Botulinum toxin Type A is approved for treatment of conditions
such as blepharospasm, cervical dystonia, and severe primary
axillary hyperhydrosis. Botulinum toxin Type A is also approved
for temporary improvement in the appearance of moderate to severe
facial frown lines. Botulinum toxin Type B is approved for the
treatment of adults with cervical dystonia; the safety and
effectiveness of botulinum toxin Type B for cervical dystonia in
children have not been established.
The FDA is not advising healthcare professionals to
discontinue prescribing these products. However, until the FDA
safety review is completed, the agency recommends that healthcare
professionals who use medicinal botulinum toxins take the
following precautions:
- 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
1 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.
SOURCE: US Food and Drug Administration
On April 4, 2008 I received the following email message from someone who found my address on this website.
My brother-in-law was diagnosed with PSP in August of 2005, he passed away on 4/2/2008. I believe his demise was hastened by the injection of botox in to his salivary glands in the hope that it would lessen the drooling problem he was so embarrassed by. He was fighting for every breath he was able to take the last three days of his life. He had aspirated pneumonia in both lungs. He got a shot of botox in
both salivary glands the first week of February, 2008 which did not
bring any relief from the drooling. The first week of March he was
given a second set of shots. The very next day he could not swallow
with aspirating what he attempted to swallow, even his own saliva.
It was horrid to see him deteriate so quickly and drastically. He
just finally stopped fighting to breathe and I do mean he had to
fight for every breath. I would hope anyone considering this botox
treatment think about it and then rethink it all again. It can help
I guess but it can also kill as we have just experienced. This
letter will not bring Stanford back but possible it will help someone
down the line.
The warning from the FDA reprinted above probably just a little too late to help this man.
What makes it even more regretable is that in this case evidently no one seemed to realize and consider that the misuse of Botox is fairly widespread.
It is used to kill or paralyze muscles and tissues. It is made from a deadly poison.
AND IT CAN AND WILL KILL WHEN MISUSED!
Ron Ritch
http:// www.pspinformation.com
/medications/medications-other/botox-warning.shtml
Document last
modified:04/22/09 10:56:51 AM