The decision on March 4, 2011, by FDA to require the manufacturers of the anti-seizure drug topiramate (Topamax) to significant strengthen warnings for woman who are or may become pregnant comes almost three years after a British epidemiological study raised serious questions concerning safety of the drug during pregnancy. FDA is now requiring the manufacturers of topiramate to significantly strengthen warnings for the drug because of increasing data linking the product to certain types of birth defects, including cleft lip and palate.
Cleft lip and cleft palate, collectively called oral clefts, are birth defects that occur when parts of the lip or palate do not completely fuse together early in the first trimester of pregnancy, a time when many women do not know they are pregnant. The defects range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, possibly leading to problems with eating, talking, and to ear infections.
Evidence linking topiramate to certain birth defects in humans is not new. Writing in the July 2008 issue of the medical journal Neurology [ “Topiramate in pregnancy — Preliminary experience from the UK Epilepsy and Pregnancy Register”], researchers reported that:
“Exposure to the antiepileptic medicine Topamax in the first trimester of pregnancy carried a higher-than-usual rate of congenital malformations.”
The researchers prospectively followed some 200 women with epilepsy who became pregnant while taking Topamax, either alone or with other antiepileptic drugs.
According to UK report, of 178 babies delivered from study subjects, 16 had major birth defects. Three of these were infants whose mothers were taking only topiramate, and 13 were in those whose mothers were taking topiramate and other epilepsy drugs. While noting that the study was both small in size and “preliminary,” the research team concluded nevertheless that “the major congenital malformation rate for topiramate polytherapy raises some concerns.”
Prior to the March 4, 2011 action by FDA to enhance pregnancy warnings for topiramate, labeling for the product classified fetal risk into what is known as “Category C,” which reflected the Agency’s opinion that reproduction studies in animal experiments showed an adverse effect on the fetus but there were “no adequate and well-controlled studies in humans,” and that “potential benefits may warrant use of the drug in pregnant women despite potential risks.” FDA’s recent action reclassifies the risk of topiramate into “Category D,” meaning that there is “positive evidence” of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans.”
The new classification continues to allow doctors to prescribe the drug in women who are or who may become pregnant where “potential benefits may warrant use of the drug in pregnant women despite potential risks.” Topiramate has been approved for the treatment of certain types of seizure disorders. Control of seizures during pregnancy may be important to protect fetal health. However, the drug has also reportedly been prescribed “off label” to non-epilepsy patients with other disorders for which the drug is not approved, including psychiatric disorders and migraine headaches, where the benefits of the drug are less clear.
In 2009 Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals Inc, manufacturers of topiramate under the name Topamax, were accused by the Department of Justice of promoting the drug to physicians for unapproved purposes. The government alleged that Ortho-McNeil Pharmaceutical promoted the sale of Topamax for off-label psychiatric uses through a practice known as the “Doctor-for-a-Day” program. Using this program, Ortho-McNeil hired outside physicians to join sales representatives in their visits to the offices of health care providers and to speak at meetings and dinners about prescribing Topamax for unapproved psychiatric uses and at unapproved doses. Once a pharmaceutical is approved by the FDA, a manufacturer may not market or promote it for any use not specified in its new drug application. The unauthorized uses are also known as “unapproved” or “off-label uses.”
Do I have a Toprimate Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Toprimate lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has given birth to a child with a congenital birth defect after taking Toprimate while pregnant, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.