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Botox Not for Pregnant Women, Australian Medical Group Warns

Jan 30, 2009 | Parker Waichman LLP

Doctors  in Australia are warning pregnant women to avoid Botox and other  wrinkle treatments made with botulinum toxin.  The warning comes after health authorities there reported that an expectant mother treated with a Botox rival called Dysport gave birth to a baby who was blind and deaf.

Several botulinum toxin treatments are currently approved for use in the U.S.  Botox, which like Dysport is made with botulinum toxin Type A, is approved for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating).  

Botox Cosmetic, which also uses botulinum toxin Type A, is approved for temporary improvement in the appearance of moderate to severe facial frown lines. Myobloc, which is made from botulinum toxin Type B, is approved for the treatment of adults with cervical dystonia.

Dysport is not currently approved as a treatment in the U.S.  However, the drug's manufacturer has submitted an application to the U.S. Food & Drug Administration (FDA), and hopes to have approval from the agency to market the drug as a treatment for cervical dystonia by mid-2009.   The maker of Dysport is also seeking approval for a version used to treat wrinkles called Reloxin. 

Last month, the Australian Federal Health and Ageing Department released documents detailing the case of a baby who was born deaf and blind in November 2005 after the mother was given facial cosmetic injections of Dysport in the first week of pregnancy.  A 2006 report on the Australian birth defect case, written by the medical services manager for Dysport manufacturer Ipsen, admits a “possible” link with the drug’s use.

On Tuesday, The Cosmetic Physicians Society of Australasia (CPSA) told its physicians to avoid using Botox and similar products on pregnant women.  "Botulinum toxin should not be prescribed to pregnant women and we advise our members to strictly follow these guidelines," said the CPSA's Dr Gabrielle Caswell said in a statement. ". . . there are some circumstances, such as during pregnancy, breastfeeding, glaucoma and neuromuscular disease where it is not an appropriate medication."

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