WASHINGTON (Reuters) - Botox and a similar injection should come with stronger warnings following reports of 16 deaths after the botulinum toxin spread inside the body, a U.S. consumer group said on Thursday. Read the entire article here
Public Citizen asked U.S. authorities to require the strongest possible warning, highlighted in a "black box," on Allergan Inc's Botox and Solstice Neurosciences Inc's Myobloc.
Botox is widely used for smoothing facial wrinkles and is approved for treating cervical dystonia, or rigid neck muscles. Myobloc is used only for the neck condition.
Both injections are made with botulinum toxin, which blocks nerve impulses to muscles causing relaxation.
Public citizen, a consumer group, examined 180 reports submitted to the Food and Drug Administration by manufacturers of Botox or Myobloc. The reports listed cases of muscle weakness, difficulty swallowing or aspiration pneumonia.
Sixteen of these cases were fatal, including four involving children under 18, Eighty-seven patients were hospitalized.
Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said such problems can occur if botulinum toxin spreads from the injection site to places such as the esophagus, causing partial paralysis.
I definitely agree with stricter regulations and better patient education programs so patients are familiar with the potential dangerous side effects when considering any elective procedure.
I do not agree with creating mass hysteria so someone can manipulate the situation for their own gain. I have seen an onslaught of pop up ads promoting "Botox alternatives" and calling this treatment "poison".
All treatments carry some risk and these should be carefully weighed against the potential advantages of treatment. I have performed cosmetic Botox in my office for many years with No Complications aside from occasional bruising.
Most common complications with Botox injections are pain, bruising and mild swelling at injection site. Drooping of eyelids can occur with too much Botox. I avoid this with "under dosing" and let my patients know we can always inject more if needed.
Unequal eyebrow raise and triangular eyebrows can commonly occur but can easily be corrected at follow up visit. I schedule my patients one week out for a follow up.
With careful technique, use of smaller needles, cleaning the area thoroughly, using less Botox these complications can be minimized. I use Zimmer chiller during my injections which keeps the area cool thereby reducing pain, bruising and swelling.
A few of my patients asked about the possibility of Botox causing Death and its important to know the facts. The FDA said the deaths it is investigating so far all involve children, mostly cerebral palsy patients being treated for spasticity of legs.
In rare cases, the Botulinum toxin can spread beyond the injection site to other parts of the body, paralyzing the muscles used for breathing and swallowing, a potentially fatal side effect. Early symptoms include dry mouth, difficulty breathing or swallowing, slurred speech, drooping eyelids and muscle weakness.
In summary legally obtained Botox made by Allergan (approved in US) used by an experienced Physician with proper injection technique for Cosmetic treatments (usually small doses) is very safe.
In addition to treating forehead wrinkles, in my office I use Botox to manage hyperhidrosis of underarms and hands safely and effectively.
For more information on Cosmetic Botox for wrinkles and and Hyperhidrosis please visit our website or call our office at 888-210-9693
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