FDA Issued Black Box Warning For Botox. On the same day it announced a black box warning for Botox and similar drugs, the Food & Drug Administration (FDA) approved another botulinum toxin injection product for the U.S. market. But as we have reported previously, Dysport has been the subject of safety concerns in Australia – specifically, that it may result in birth defects if used to treat expectant mothers.
Like Botox and Botox Cosmetic, Dysport is made from botulinum toxin type A. It was approved by the FDA yesterday as both an anti-wrinkle treatment, and for treating spasms of the neck muscles. The drug is manufactured by Medicis Pharmaceutical Corp. of Scottsdale and its partner, France’s Ipsen SA. The cosmetic version of Dysport should be available in the U.S. within the next 30 to 60 day. The medical form should be available during the second half of the year.
case of a baby who was born deaf and blind
Late last year, we reported that the Australian Federal Health and Ageing Department had 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 Ipsen, admitted a “possible” link with the drug’s use.
A month later, the Cosmetic Physicians Society of Australasia (CPSA) told its physicians to avoid using Dysport 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.”
The same day the FDA approved Dysport, it ordered the manufacturers of botulinum toxin injection products to add black box warnings – the agency’s strictest safety alert – to their labels regarding their risk of potentially life-threatening complication when the effects of the toxin spread far beyond the injection site.
symptoms have mostly been reported in children
According to the FDA, such an occurrence can cause symptoms similar to those of botulism, including unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids. The agency said such symptoms have mostly been reported in children with cerebral palsy being treated with the products for muscle spasticity, an unapproved use of the drugs. Symptoms have also been reported in adults treated both for approved and unapproved uses.
The new warning label will apply to Dysport, as well as Allergan’s Botox and Botox Cosmetic and Solstice Neurosciences’ Myobloc. Botox Cosmetic is approved as a wrinkle treatment. Myobloc and Botox are approved for the treatment of spasms of the neck muscles. Botox is also approved for the treatment of severe underarm sweating (primary axillary hyperhidrosis), crossed eyes (strabismus), and abnormal tics and twitches of the eyelids (blepharospasm).
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