Botox Dysport Birth Defects

Botox and Dysport: Botulinum Type-A Drugs and the Potential for Birth Defects

According to Australian health officials, the anti-wrinkle treatment Dysport is known to cause serious birth defects when used to treat pregnant women. The nearly identical drug known as Botox was approved by the United States Food and Drug Administration (FDA) over 2 decades ago and its use as a cosmetic anti-aging treatment has rapidly risen over the past few years. Both of these anti-wrinkle treatments are botulinum type-A toxins containing the same active ingredient. See these recent articles from Fox News and News.com for additional information concerning the risks of botulinum toxin.

The problems associated with the use of Dysport on pregnant women can include blindness, deafness or other severe birth defects in the newborn baby. In November of 2005, according to the Australian Federal Health and Ageing Department, the use of Dysport by a mother during her first week of pregnancy led to her child being born both blind and deaf. Because Dysport and Botox are virtually identical, questions have begun to surface about the potential for the same type of birth defects stemming from the use of Botox by American women during pregnancy.

Botox Risks: FDA Black Box Warning

The FDA issued an order in April of 2009 requiring Botox and other anti-wrinkle drugs of the same type to carry its most stringent warning label, known as a “black box” warning. According to the FDA, this “black box” warning is necessary because of the potential for the botulinum toxin to spread from the injection site to other areas of the body. This potential for the drug to creep throughout the body can lead to serious problems for some patients, including difficulty breathing or swallowing. While normally reserved for medications with life-endangering risks, the “black box” warning is an indication of the very real potential for dangerous complications associated with the use of botulinum toxin.

Dysport Comes To America

Following the partnership of Dysport’s manufacturer, Ipsen, with another manufacturer, Medicis Pharmaceutical, the drug Dysport was submitted to the FDA for approval. In April of 2009, the FDA approved Dyport for use in the U.S. market as a cosmetic treatment. Dysport is specifically approved to treat frown lines as well as cervical dystonia. The frown line treatment will be marketed by Medicis while the dystonia treatment will be marketed under the Ipsen brand.

While Dysport has been approved for sale in the United States, it will still be required to carry the same “black box” warning that Botox currently carries. This is the result of a petition from the advocacy group Public Citizen which demanded that the FDA add serious warnings to the drug’s packaging. Public Citizen cited the fact that the FDA received at least 180 adverse event reports including 16 deaths stemming from the injections. The FDA responded by admitting that it had actually identified 225 adverse event reports linked to the drug and its tendency to spread from the injection site to other parts of the body.

If you or someone you love has been injured by Botox or Dysport, contact the experienced cosmetic treatment injury lawyers at Zehl & Associates, LLP at our toll-free number for a free consultation. Our Botox and Dysport injury attorneys aggressively represent clients in Texas and across the entire United States. Contact us today.