Topamax Linked to Birth Defects
Topiramate (Topamax) Found to Cause Cleft Lip and Cleft Palate Birth Defects
A study by the North American Antiepileptic Drug (NAAED) Pregnancy Registry has shown an increased risk of oral cleft birth defects in infants whose mothers had taken Topamax in the first trimester of their pregnancy. The study resulted in Topamax (topiramate) being recategorized by the Federal Food and Drug Administration (FDA) as a Pregnancy Category D antiepileptic drug. Previously, Topamax had been categorized as a Pregnancy Category C drug for controlling epilepsy.
Oral Cleft Birth Defects Occur in First Trimester of Pregnancy
Oral cleft birth defects include both cleft lip and cleft palate. Either birth defect occurs in the first trimester of pregnancy, a time when a woman may be unaware that she is pregnant, and affects the infant’s upper lip and roof of the mouth. Early in the infant’s development, about five to six weeks after conception, the lip tissue joins in the middle and fuses together. The tissue that will become the baby’s palate goes through the same process at about seven weeks. When the process goes awry, the tissue does not join together properly and a cleft lip or cleft palate results. The area affected may range from a small notch in the baby’s lip to a grove or opening running into the infant’s mouth and nose. Not only can this affect the child’s appearance but it may also cause problems with eating, talking and may increase the frequency of ear infections.
Whether the oral cleft is a cleft lip or cleft palate, it can be corrected with surgery. For a cleft lip, depending on the surgeon’s recommendation, it is generally repaired when the baby is around three months old. A cleft palate, again depending on the surgeon’s recommendation, is generally repaired when the infant is somewhere between 6–18 months old. A child born with either cleft lip or cleft palate may need additional surgery as he or she grows.
It should also be noted that Topamax passes into the breast milk. If you are a nursing mother or pregnant and are taking or have taken Topamax or a generic form of topiramate, we urge you to consult your doctor or healthcare professional immediately.
Topamax Originally Approved as an FDA Pregnancy Category C Drug
Pregnancy Category C drugs are those drugs that if taken during pregnancy may cause birth defects but there is no human data available from clinical trials or studies to definitively support this. When the FDA first approved Topamax for market as an anticonvulsant medication, data from testing on pregnant women was unavailable. Animal testing did suggest that there was a distinct possibility for birth defects as a result of taking the medication. Topamax was also approved for use in the prevention of migraines though not as a pain reliever. It has also been used off–label—i.e., unapproved uses—to treat other conditions. It is an unfortunate aspect of the pharmaceutical industry that in the rush to get a product to market, and to reap profits from it, adequate testing is often bypassed.
From January 2007 to December 2010, around 32.3 million topiramate prescriptions were filled, 4.3 million of which were filled by pharmacies in the U.S. Recently, in reviewing the data collected by the NAAED Pregnancy Registry, it was found that 1.4% of babies whose mothers had taken topiramate as an antiepileptic medication in the first trimester of pregnancy were born with an oral cleft birth defect. This is more than double the percentage of babies born with oral cleft defects whose mothers took other antiepileptic drugs during pregnancy.
In light of these findings, the FDA reclassified Topamax as a Pregnancy Category D drug as there is now human data showing a link between Topamax and infant birth defects. The FDA also worked with the drug’s manufacturer, Ortho–McNeil–Janssen Pharmaceuticals, Inc., to update the drug’s label. Russell Katz, M.D., director of Division of Neurology Products for the FDA’s Center for Drug Evaluation and Research, said, “Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age. Alternative medications that have a lower risk of birth defects should be considered.”
Topamax Legal Help for You and Your Child
As a law firm, we cannot give you medical advice but urge you to contact your doctor or healthcare professional if you are pregnant or nursing and have taken Topamax or a generic form of topiramate. If you took Topamax (topiramate) during the first trimester of your pregnancy and your baby was born with either a cleft lip or cleft palate, we are here to help you with any legal issues you may have during this difficult time. Please contact us, either through this web site, or by calling 1–866–809–5240 to receive a free evaluation of your potential Topamax (toiramate) case.
