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Thread: Group seeks Botox warning following 16 deaths

  1. #1
    Elite Member celeb_2006's Avatar
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    Default Group seeks Botox warning following 16 deaths

    Group seeks Botox warning following 16 deaths

    Group seeks Botox warning after 16 deaths - Skin and beauty -

    WASHINGTON - Botox and a similar injection should come with strong warnings following reports of 16 deaths and other serious problems after the botulinum toxin spread inside the body, a U.S. consumer group said on Thursday.
    Public Citizen asked U.S. authorities to require the strongest possible warning, highlighted in a "black box," on Allergan Inc's Botox and Solstice Neuroscience Inc's Myobloc.
    Botox is famous for smoothing facial wrinkles but also has approved medical uses such as treating cervical dystonia, or rigid neck muscles. Myobloc is cleared only for the neck condition.
    Both injections are made with forms of the botulinum toxin, which can paralyze muscles.
    Public Citizen said it reviewed 180 reports submitted to the Food and Drug Administration by manufacturers involving patients injected with Botox or Myobloc. The reports detailed cases of muscle weakness, difficulty swallowing or aspiration pneumonia, a serious condition caused by breathing a foreign material into the lungs.
    Reports to the FDA do not prove a product caused a particular problem, but the agency uses them to look for patterns of potential complications.
    Officials at Allergan, Solstice and the FDA could not immediately be reached for comment.
    Sixteen of the cases reported were fatal, including four involving children under 18, Public Citizen said. Some 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 the esophagus, causing partial paralysis. Instructions for Botox and Myobloc mention the issue but it is easy to miss, he said.
    Public Citizen asked the FDA to order a black-box warning to highlight the concern, plus a letter to doctors. The agency also should require a consumer-friendly guide explaining the risks that would be handed out by doctors when the drug is injected, the group said.
    "These significantly improved warnings to doctors and patients would increase the likelihood of earlier medical intervention when symptoms of adverse reactions to botulinum toxin first appear, and could prevent more serious complications, including death," Public Citizen said in a petition to the FDA.
    The group said European regulators have warned physicians to watch for signs of botulinum toxin complications, most recently in March 2007.

  2. #2
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    16 people died?!

  3. #3
    Elite Member McJag's Avatar
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    Feb 2007


    Yes-they had this on NBC yesterday. 15 of the 16 had it for medical reasons-not fun. This is out of thousands of cases! And the doctor did say it was meant for forehead use only . Anything near/by the throat could travel-leading to problems swallowing. This really is no biggie.
    I didn't start out to collect diamonds, but somehow they just kept piling up.-Mae West

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    Elite Member ariesallover's Avatar
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    here, soon to be over there


    Were the medical issues all for stiff neck? I'm wondering if any of the patients were injected because of needing migraine treatment, which sometimes hits around the throat but is mostly scalp and face.

    Also, if the effects of the Botox occur within the first 15 minutes or so, why weren't the problems handled in the medical setting? Stuff with a risk of complication along these lines usually require that the patient sit tight for an hour or so to jump on problems like this. Seems odd that the monitoring of patients who were getting injections near the throat were not handled in this manner, especially as this risk is not news to medical providers.
    "I ransacked his drawers when he left me by myself at his place for the first time. That's how we did it in the good old days. Tells me all I need to know about him. He pretends he didn't notice. That's how good relationships start." - Chilly Willy

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    Elite Member msdeb's Avatar
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    in a van down by the river


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