четверг, 21 февраля 2008 г.

Botox should carry stronger warning label, public-interest group says

> Medical News BOTOX SHOULD CARRY STRONGER WARNING LABEL, PUBLIC-INTEREST GROUP SAYS Public Citizen has asked the FDA to require stronger warnings for botulinum toxin (Botox and Myobloc), the _New York Times_ reports.On searching the FDA's adverse event database, Public Citizen found 180 manufacturer-submitted reports of dysphagia, aspiration, or pneumonia associated with Botox or Myobloc from 1997 through 2006.These patients, 16 died; most had received the drugs for muscle spasticity or unspecified reasons.One death involved wrinkle treatment, and Allergan, which makes Botox, says that death resulted from unrelated staphylococcus pneumonia.Adds that there's no proof of cause and effect in the other deaths.Public Citizen has asked the FDA to require Allergan and Solstice Neurosciences, which makes Myobloc, to write letters to doctors warning of possible hazards if botulinum toxin spreads from the injection site to other parts of the body.Group has also requested black-box warnings on the products' labels and MedGuides for patients.(One-time registration required) (Free) (Free) (Free PDF) (Free PDF) (Free PDF) _Published in_ Physician's First Watch _January 28, 2008_ SEARCH Enter keywords ARTICLE TOOLS SHARE SIGN-IN Username Password Remember Me NEW TO JOURNAL WATCH?2008.
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