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VIRTUALISATION FDA to strengthen warnings on Botox type drugs
VIRTUALISATION FDA to strengthen warnings on Botox type drugs | FDA to strengthen warnings on Botox type drugs |
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| by William Atkins | |
| Friday, 01 May 2009 | |
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Page 1 of 3   
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The April 30, 2009 Wall Street Journal article “FDA Strengthens Warnings On Allergan's Botox,” states the FDA announced on Thursday, April 30, 2009, that it would require stronger warnings on Allergan’s Botox, and other similar toxins. This strengthened warning is due to the risk from breathing and swallowing problems associated with the drug’s medical use. The FDA says these problems are potentially life-threatening. The warning has also been added to these products because of rare reported deaths and hospitalizations in adults and children treated with the C. botulinum toxin for medical conditions, but not cosmetic reasons. Symptoms reported have also included muscle weakness, trouble talking, loss of bladder control, and blurred vision. In September 2005, the FDA reported that 28 deaths had occurred from the medical use of Botox from 1989 to 2003. [Coté TR, Mohan AK, Polder JA, Walton MK, Braun MM. "Botulinum toxin type A injections: adverse events reported to the US Food and Drug Administration in therapeutic and cosmetic cases". J. Am. Acad. Dermatol. 53 (3): 407–15.] The bacterium species Clostridium botulinum is used by manufacturers to produce Botox (advertised as a “wrinkle smoother”) and other such related drugs. The bacterium produces the neurotoxic protein botulin. It works in Botox-type drugs by relaxing or paralyzing certain muscles. When wrinkles disappear after its applications, the drug has actually relaxing that muscle. Page two talks about bolulinum and botulin, and their relationship to botulism. |
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