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    Sunday, May 10, 2009


    Yesterday’s article dealt with illegal silicone treatments. Today we will mention the most popular “legal” cosmetic treatment – that of Botox.

    You have probably read the news articles and perhaps heard rumors about recent Botox complications. While Botox is best known for clearing wrinkles by paralyzing facial muscles, the botulin-based drug also is widely used for muscle-spasm conditions. Botox and Myobloc, are designed to block nerve impulses to certain muscles, causing them to relax. Both drugs are approved to treat cervical dystonia, or uncontrolled muscle contractions of the neck and shoulder muscles.

    In addition, Botox is approved for cosmetic use to treat wrinkles between the eyebrows and to help control excessive underarm sweating. Lower doses are used by professionals for cosmetic purposes than those used to treat limb spasticity.

    In rare cases, however, the toxin can spread beyond the injection site to other parts of the body. This will cause paralyzing or weakening the muscles used for breathing and swallowing, a potentially fatal side effect.

    Signs of botulism can appear just hours after injection and include
    • difficulty swallowing or breathing,
    • slurred speech and
    • muscle weakness.

    The FDA said it uncovered 225 cases of botulism related to the drugs during its analysis and 17 deaths for which its analysis seemed to suggest botulism as a cause.
    Botox, Botox Cosmetic, and Myobloc are approved for "temporary improvement in the appearance of glabellar lines, treatment of strabismus, blepharospasm, cervical dystonia, and primary axillary hyperhidrosis.

    An FDA statement, however, reassured the public. To date, none of the cases...reported have been associated with use of botulinum products in cosmetic or dermatological procedures, such as clearing furrows between the eyebrows, according to the FDA.

    Indeed the FDA has just approved sales of new Botox like drug.

    Ipsen SA and Medicis Pharmaceutical Corp. won US Food and Drug Administration approval to sell their product, Dysport [botulinum toxin type A], for both aesthetic and therapeutic uses. Like Botox [botulinum toxin type A], the new injection uses a type of botulinum toxin to relax the muscles that cause forehead lines and a neck-twisting disorder called cervical dystonia. The company will start selling the drug for aesthetic uses in the US within 30 to 60 days." Dysport injections may take effect more quickly than Botox, which typically takes three to 10 days before patients notice that wrinkles begin smoothing.

    The FDA stated that even though "there have been reports of symptoms consistent with distant spread of the toxin effects following dermatologic definitive serious adverse-event reports of this effect were associated with use of Botox at the labeled dose of 20 units for glabellar lines or 100 units for severe primary axillary hyperhidrosis."

    How Should Botox be Given?

    First make sure it’s given by a medical professional.

    Botox parties given in peoples homes may be dangerous when given by non authorized personnel.

    Patients should know that the practitioner must follow the FDA’s recommendations made in the 2008 Early Communication; that healthcare professionals who use botulinum toxin products should:

    • Understand that dosage strength (potency) expressed in “Units” or “U” are different among the botulinum toxin products.
    • Clinical doses expressed in units are not interchangeable from one botulinum toxin product to another.
    • Be alert to and educate patients and caregivers about potential adverse events due to distant spread of botulinum toxin effects following local injections including:
    • unexpected loss of strength or muscle weakness,
    • hoarseness or trouble talking
    • (dysphonia), trouble saying words clearly
    • (dysarthria), loss of bladder control,
    • trouble breathing,
    • trouble swallowing,
    • double vision, blurred vision and drooping eyelids.

    Understand that these adverse events have been reported as early as several hours and as late as several weeks after treatment.

    Patients must seek immediate medical attention if they develop any of these symptoms.

    The FDA urges both healthcare professionals and patients to report side effects from the use of Botox and Botox Cosmetic (Botulinum toxin Type A), Myobloc (Botulinum toxin Type B), and Dysport (abobotulinumtoxinA) to the FDA's MedWatch Adverse Event Reporting program.

    • online at
    • by returning the postage-paid FDA form 3500 available in PDF format at to 5600 Fishers Lane, Rockville, MD 20852-9787
    • faxing the form to 1-800-FDA-0178
    • by phone at 1-800-332-1088

    Please remember, as with all our articles we provide information, not medical advice.

    For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.

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