By Independent Staff Writer Topamax,
also known as topiramate, is a prescription drug used to treat epilepsy
in adults and children. The drug is also approved by the Food and Drug
Administration to treat migraine headaches, and has been prescribed to
treat bipolar disorder, obesity, and alcoholism.
Research studies have identified a risk of birth defects in children associated with mothers who took Topamax during pregnancy. Topamax has been linked to serious birth defects including cleft palate and cleft lip. These defects result in a notch or groove in the lip that can extend into the roof of the mouth and the nose, possibly causing ear infections and problems with eating and speaking. Cleft lip and palate can possibly be corrected with surgical procedures. Other birth defects potentially connected with Topamax include heart, lung, brain, and limb defects.
Research studies have identified a risk of birth defects in children associated with mothers who took Topamax during pregnancy. Topamax has been linked to serious birth defects including cleft palate and cleft lip. These defects result in a notch or groove in the lip that can extend into the roof of the mouth and the nose, possibly causing ear infections and problems with eating and speaking. Cleft lip and palate can possibly be corrected with surgical procedures. Other birth defects potentially connected with Topamax include heart, lung, brain, and limb defects.
According
to data from the North American Antiepileptic Drug Pregnancy Registry
(NAAED), there is an increased risk of cleft palate and cleft lip in
children born to women who took Topamax during the first trimester of
pregnancy. This data shows that cleft palate or cleft lip is over twice
as likely to occur in a newborn baby exposed to Topamax compared to a
different epilepsy drug, and over twenty times as likely to occur in a
newborn not exposed to any epilepsy drug. This research is of concern
because many women may not know they are pregnant during the first
trimester.
In
response to the data indicating birth defect risks for Topamax, the Food and Drug Administration (FDA) recently increased the warnings in
Topamax packaging to inform patients of the risks of birth defects while
taking this drug. Topamax has been placed in Pregnancy Category D,
which means that there is positive identification of a fetal risk based
on human data, although the benefits of taking the drug for pregnant
women may be acceptable in certain situations despite the risk.
The
FDA has also recommended that women who intend to become pregnant
should discuss the use of alternative therapies with their health care
professionals before taking Topamax. Physicians are recommended to
consider prescribing drugs for their patients with lower risks of cleft
palate and cleft lip. Women who are concerned about the risks of taking
Topamax should consult with a qualified healthcare professional.
Litigation
concerning Topamax and birth defects is ongoing. Some of the lawsuits
involve Johnson and Johnson, the brand-name drug manufacturer, which has
paid over 80 million dollars in fines for marketing Topamax for
unapproved uses. The more recent data indicating birth defect risks has
resulted in more lawsuits being filed.
If
you think that your child may have suffered a birth defect related to
taking Topamax during pregnancy, you may have valuable rights. It is
important that you retain all pertinent medical records and bills to
help you obtain any compensation to which you may be entitled. It is
also important for you to speak with a qualified drug injury attorney
about your rights and your potential for any compensation that may be
due to you and your family.
