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Botox Rival and Birth Defects: A Possible Link

Dec 30, 2008

Keywords: Botox Lawyer Birth Defects Attorney

The lawyers at our firm are offering free consultations to anyone treated with Botox  or similar products while pregnant, who later had a child with birth defects.  In December 2008,  Australian authorities reported that a wrinkle treatment called Dysport had been linked to severe birth defects in one child.  Dysport contains botulinum toxin Type A, the active ingredient in Botox and Botox Cosmetic.

Consumer information for Botox and Botox Cosmetic recommends against treatment when pregnant.  However, in light of the safety issues reported in Australia, the Botox birth defect lawyers at our firm are concerned that these warning are inadequate, and do not offer enough protection to patients. 

If your child suffers from birth defects that might be tied to Botox or Botox Cosmetic, you may be entitled to compensation.  Please contact our Botox birth defect lawyers as soon as possible to protect your legal rights.

Australian Birth Defect Report

In December 2008, the Australian Federal Health and Ageing Department released documents detailing a case of severe birth defects in a child whose mother was treated with Dysport while pregnant.  The Botox birth defect lawyers at our firm are conducting an investigation to find out if people treated with other botulinum toxin Type A products, such as Botox and Botox Cosmetic, have had similar experiences.
 

According to Australian health regulators, the baby was born deaf and blind in November 2005 after the mother was given facial cosmetic injections of Dysport in the first week of pregnancy.  The case was among 46 different adverse reactions to botulinum toxin Type A  reported to the Therapeutic Goods Administration since July 1, 1994.  A 2006 report on the Australian birth defect case, written by the medical services manager for Dysport manufactur Ipsen, admits a "possible" link with the drug's use.

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.  If either of these treatments are approved, our Botox birth defect lawyers will be watching closely to see if patients experience problems similar to what was reported in Australia.
 

Other Side Effects

Several botulinum toxin treatments are currently approved for use in the U.S.  These include Botox, Botox Cosmetic and Myobloc.  Our Botox birth defect lawyers would like to hear from anyone whose child suffered a birth defect following treatment with any of these medications.

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 addition to a possible association with  birth defects, these drugs have been linked to other serious side effects.  Our firm is also offering free consultations to anyone suffering from other problems possibly associated with Botox, Botox Cosmetic or Myobloc.

In January 2008, the consumer advocacy group Public Citizen petitioned the FDA to strengthen warnings on the products' labels because of serious adverse reactions. An analysis conducted by Public Citizen of FDA data found that between Nov. 1, 1997, and Dec. 31, 2006, the makers Botox, Botox Cosmetic and Myobloc had reported 180 U.S. cases of people developing serious conditions after receiving injections. Those 180 cases included 16 deaths, four of which occurred in children.

In February 2008, the 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. The most serious cases had outcomes that included hospitalization and death.  The FDA said that the adverse reactions may have been due to overdosing.

The reports of adult botulism cases described symptoms including patients experiencing difficulty holding up their heads, dysphagia and ptosis.  Some reports described systemic effects that occurred distant from the site of injection and included weakness and numbness of the lower extremities.

Legal Help for Victims of Botox Birth Defects

If your child suffers from birth defects that you believe are the result of treatment with Botox, Botox Cosmetic or Myobloc, you may have valuable legal rights. Please fill out our online form or call 1-800 LAW INFO (1-800-526-4636) as soon as possible to discuss your case with one of our Botox birth defect lawyers.