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FDA issues an Early Communication about an Ongoing Safety Review for Botox and Botox Cosmetic

FDA issues an Early Communication about an Ongoing Safety Review for Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B)

This information reflects FDA's current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug products and the emerging safety issue.  Nor does it mean that FDA is advising healthcare professionals to discontinue prescribing these products. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.

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fda-communication-about-botox.doc

Acerca de Juan Antonio Chassaigne

Profesor Titular de Farmacología, Universidad Nacional Experimental "Francisco de Miranda" y Hospital "Dr. Rafael Calles Sierra", IVSS / UNEFM

2 comentarios

  1. Estimado Juan Antonio: Te me adelantastes ya que pensaba enviarte por tu mail, el informe de la FDA sobre el Botox y los peligros que entraña, especialmente en el tratamiento de niños con parálisis cerebral asociada a espasticidad en miembros.

    En éste escrito de Physician´s First Watch, feb 11,2008,que te envío, podrán encontrar además del informe de la FDA, un artículo publicado en el Wall Street J. y otros links relacionados.

    FDA Investigating Safety of Botulinum Products

    The FDA announced on Friday that it is investigating reports of systemic adverse reactions suggestive of botulism in patients, mostly children, treated with botulinum toxin type A (Botox and Botox Cosmetic) and type B (Myobloc).

    The reactions reported include respiratory compromise; they occurred at a variety of doses and following treatment for various conditions. However, many of the most serious cases — involving hospitalization or death — occurred in children treated for cerebral palsy-associated limb spasticity. The FDA has not approved botulinum products to treat this condition.

    While the investigation continues, the FDA advises clinicians to:

    understand that clinical doses, expressed in units, are not comparable among the three botulinum products;
    watch for systemic effects (including dysphagia, dysphonia, weakness, dyspnea, and respiratory distress), which can occur 1 day to several weeks after botulinum administration;
    educate patients and caregivers about the signs and symptoms of systemic effects;
    warn patients to seek immediate medical attention if they experience muscle weakness or difficulty swallowing, talking, or breathing.

    FDA early communication on Botox review (Free)

    Wall Street Journal story (Free)

    Related Journal Watch link(s):
    Physician’s First Watch coverage of Public Citizen’s call for stronger warning on Botox label (Free)

    Un saludo cordial
    Dr. Guillermo Planas Girón
    Caracas-Venezuela

  2. Estimado Dr. Planas: Gracias por la información complementaria, en este Blog en fecha 13 de Julio de 2007, coloque una nota casi idéntica a la emitida por la FDA, – (Toxina Botulínica: Riesgo de Efectos Adversos Graves por Diseminación de la Toxina)- cuya autoría pertenece a la Agencia Española de Medicamentos y Productos Sanitarios. Últimamente, la Agencia Europea de Medicamentos y otras agencias europeas, emiten advertencias y alertas mucho antes que la FDA y se ha empezado a cuestionar fuertemente el papel y la celeridad de respuesta de la FDA.

    Saludos

    Juan Antonio Chassaigne

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