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Posts in the ‘Topamax’ category

Birth defects when Paxil, Depakote & Topamax are taken during pregnancy

Posted on April 26th, 2011

Do you, a friend, or loved one have a child that has suffered from a birth defect? Please consider the following information: spina bifida, cleft palette, and heart valve malformations are all examples of conditions that may be related to medications taken during pregnancy. Children with these conditions face years of specialized medical care and often need multiple surgeries before the age of ten. Many parents don’t realize that medications can affect fetal development because the drug manufacturer does not warn them of the danger. While investigating any potential claim, it is our goal to provide the family with answers to their questions and concerns, and help recover the costs of present and future medical treatment.

The following are drugs that may be related to birth defects:

TOPAMAX (topiramate), a popular drug that is prescribed to prevent epileptic seizures and migraines, has been on the market since 1997. It may interfere with fetal development if taken during the first trimester when the fetus is growing and fusing together both sides of the upper lip and palette (the roof of the mouth). Cleft lips and cleft palettes require several surgeries to close the gap caused by the toxin.

In March 2011, the U.S. Food and Drug Administration (FDA) issued a safety communication for patients and doctors warning of the link to oral clefts. If you or a loved one has a child with a cleft lip or palette and the mother may have taken topamax or oral medication for seizures or migraines, please allow us to see if we can help.

DEPAKOTE (divalproex sodium) is drug used to treat seizures, manic depression, migraine headaches, and chronic pain. Research shows there may be a link to spina bifida when taking this medication during pregnancy. Depakote may interfere with the closing of the fetal spinal column, which is supposed to occur in the first month of pregnancy.

Babies born with spina bifida have an opening in the spinal column that puts them at risk for infection and spinal cord damage. These infants must undergo several surgeries to repair the damage. If you or a loved one has a child with spina bifida, please allow us to see if we can help.

PAXIL (paroxetine) is an antidepressant medication that has been prescribed since 1992 for depression, anxiety and obsessive compulsive disorders. In 2005, the U.S. Food and Drug Administration (FDA) issued a safety communication for patients and doctors warning of the possible link to heart valve defects in infants. When Paxil is taken during pregnancy it may cause atrial septal and ventricular septal defects (ASD or VSD). These defects are holes in between the chambers of the heart that are supposed to be separated. The hole allows some of the blood to flow in the wrong direction.

Heart defects often require multiple surgeries at an early age. If you or a loved one has a child with heart defects and the mother may have been on antidepressants, please allow us to see if we can help.

For more information, contact Goldenberg Heller Antognoli & Rowland, P.C.

The Topamax and birth defects connection

Posted on April 14th, 2011 by Robert D. Rowland

We read every day about prescription drugs which harm people in ways they never imagined, with risks they would have never taken. As a parent, the only thing worse than taking a drug that harms you unexpectedly, is taking a drug which harms your child unexpectedly. Unfortunately, in March 2011, the U.S. Food and Drug Administration (FDA) issued a safety communication for patients and doctors warning of the risk of birth defects from the use of Topamax, a drug prescribed for treatment of epileptic seizures and chronic migraines.

Topamax (Topiramate) has been on the market since 1997. It was originally approved by the FDA for use to treat seizures. In November 2002, it was approved to treat migraines. Around the time of initial approval, literature began to surface suggesting an increased risk of giving birth to children with cleft lip and/or cleft palate to mothers who took Topamax during their first trimester of pregnancy. The tissue that becomes the lip forms as early as 5 to 6 weeks after conception, while the palate forms at 7 to 11 weeks after conception. The damage is done often before the mother even knows she is pregnant!

Despite the known birth defect risk, no warnings were provided to patients or doctors. According to the FDA news release dated March 4, 2011, data received from the North American Antiepileptic Drug Pregnancy Registry showed that the risk of cleft palates in infants exposed to Topiramate (Topamax) was over three times higher than the risk of cleft palates from other antiepileptic drugs. Only 0.07% of infants born to mothers who took no antiepileptic drug were born with cleft palates, while infants whose mothers took Topamax were 20 times more likely to have cleft palates.

Beyond the cleft palate and cleft lip injuries, additional birth defects have been linked to lesser degrees of use of Topamax in the first trimester. Topamax use has also been associated to limb malformation, heart defects, congenital defects, craniofacial defects, spina bifida and genital malformations.

Our firm is currently representing families who have been damaged by Topamax and would be happy to provide more information to concerned parents.

For more information on Topamax and birth defects, contact Robert D. Rowland.

Increased risk of cleft lip in infants born to women taking Topamax

Posted on March 16th, 2011 by Katie A. Hubbard

The U.S. Food and Drug Administration issued a safety announcement informing the public that new data has shown the drug Topamax (topiramate) can increase the risk of oral clefts in children born to women taking this anticonvulsant medication during pregnancy. Topiramate is FDA-approved to treat patients that have epilepsy, have certain types of seizures, or to prevent migraines. Although commonly prescribed, it has not been approved for other uses. Topiramate has been classified as a Pregnancy Category D drug, which indicates that there is evidence of human fetal risk based on human data but the potential benefits of the drug in pregnant women might be acceptable despite the risks. It was previously placed in Pregnancy Category C due to initial animal testing that presented potential fetal risks. However, at that time there was no sufficient human clinical data available.

An oral cleft is a defect that can occur in the upper lip and roof of the mouth causing problems with eating, talking, ear infections, and appearance. Both the North American Antiepileptic Drug Pregnancy Registry and the UK Epilepsy and Pregnancy Register found an increased prevalence in the amount of oral clefts in infants exposed to topiramate compared to the risk in the background population of untreated women. Due to the higher risk of infants developing an oral cleft or cleft lip if their mother has taken Topamax (topiramate), women of childbearing age should consult healthcare professionals about other options.

The FDA changed the Pregnancy Category of topiramate because of the recent human data indicating an increased risk in oral clefts in infants exposed to the drug during pregnancy. Topiramate labels are being changed to reflect these findings and make patients, especially women of childbearing age, aware of this increased risk.

If you or anyone you know has taken Topamax (topiramate) during pregnancy, our firm is investigating claims involving these injuries and we would like help. Contact us today.