Copenhagen, DenmarkThe scourge of Topamax and the potential for Topamax side effects has been borne out in an extensive study recently published in the Journal of the American Medical Association (JAMA) regarding the relationship between topiramate (Topamax) use by expectant mothers and the emergence of birth defects.
According to the JAMA-published study, 837,795 live-born infants were studied in Denmark between January 1, 1996 through September 30, 2008. Of 1,532 infants exposed to Topamax as well as other drugs during the exhaustive study, 49 of the infants were subsequently diagnosed with a major birth defect.
For topiramate exclusively, 4.6 percent of the infants exposed to the anti-seizure drug were found to have suffered a Topamax birth defect.
Among the birth injuries linked to Topamax and pregnancy are genital malformations, Hyposadias, Spina bifida or limb malformations, Persistent Pulmonary Hypertension (PPH), and heart, lung and neural defects.
However, it is the potential for cleft palate and/or cleft lips that provides the most tragic stories. Such Topamax birth defects are on the outside and readily apparent for all to see. While such deformities can be corrected with surgery, numerous surgical procedures are often required to correct the problem.
Not only is this an ongoing expense (and not every family can bear such an expense) but is also taking place during a child's formative years. Such a noticeable deformity can affect a child's speech development, eating habits (and therefore, physical development). Such an awareness of being different can also affect a child's emotional well-being and confidence.
It was noted in the May 27 issue of Lead Counsel Corner that serious Topamax side effects such as cleft palate and cleft lip appeared to increase in tandem with a woman's use of Topamax either prior to or during pregnancy. There have also been accusations that some potential side effects were not properly disclosed on product labeling.
Earlier this year, the US Food and Drug Administration (FDA) took steps to strengthen the warning label for Topamax, as well as initiate a change to the pregnancy classification for Topamax, moving it from a Class C to a Class D medication.
Such cautions, however, do little to console the mother dealing with Topamax side effects in children. She may not have even been aware of the risk. Were she to have had an opportunity to made changes to her medication prior to becoming pregnant, might this tragedy have been prevented?
The presence of a Topamax Cleft Lip or Topamax Cleft Palate could potentially have been avoided in the prescience of correct information, rather then a vacuum. Instead, a family is made to suffer financially and a child is made to suffer emotionally through no fault of their own.
If you or a loved one have suffered losses in this case, please click the link below and your complaint will be sent to a drugs & medical lawyer who may evaluate your Topamax claim at no cost or obligation.