Birth Defects Linked to Botox - Type DrugDec 30, 2008 | Parker Waichman LLP
New questions are being raised about the safety of Botox and similar wrinkle treatments after Australian health regulators revealed that a mother treated with another botulinum toxin Type A product gave birth to a baby with severe birth defects. The drug implicated in that incident is called Dysport, which while not yet approved in the U.S., contains the same active ingredient found in Botox and Botox Cosmetic.
Earlier this week, 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.
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.
In February 2008, the U.S. Food & Drug Administration (FDA) announced that Botox, Botox Cosmetic and Myobloc would undergo a safety review following reports of serious side effects, including the deaths of some children. According to the FDA, most of the severe reactions occurred in children treated for limb spasticity associated with cerebral palsy, an off-label use of the drugs. At the time, the FDA said that many reported reactions resembled botulism, and occurred when botulinum toxin spread beyond the site where it was injected.
While Dysport is not currently approved as a treatment in the U.S, the drug's manufacturer has submitted an application to the 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.