Johnson & Johnson’s blockbuster epilepsy drug, Topamax, may be linked to an increased risk of devastating birth defects in babies whose mothers take the medication while pregnant, including cleft lip, cleft palate and genital defects like hypospadias. In fact, research has shown that unborn babies exposed to Topamax in the womb may be at much as 20 times more likely to develop devastating congenital malformations like cleft lip and cleft palate, compared to babies exposed to no anticonvulsant drugs in utero. If you took Topamax during early pregnancy, and your child was born with an oral cleft or another serious birth defect, consult a knowledgeable Topamax lawyer today for legal help. You may be entitled to compensation for your child’s congenital malformations, which you can pursue by filing a Topamax lawsuit against Johnson & Johnson.
Epilepsy is a serious brain disorder involving repeated, spontaneous seizures, or episodes of disturbed brain function caused by abnormally excited electrical signals in the brain. In order to treat epilepsy and decrease the frequency and intensity of seizures, many individuals are prescribed anticonvulsant drugs like Topamax. However, in light of the potential risk of birth defects associated with Topamax use in pregnancy, some women prefer alternative treatments for epilepsy, including the following:
On March 4, 2011, the FDA required Johnson & Johnson to strengthen warnings for its Topamax drug, in light of research linking the medication to certain types of birth defects, including cleft lip and cleft palate. In its safety communication, the FDA states that “The benefits and the risks of topiramate should be carefully weighed when prescribing this drug to women of childbearing age, particularly for conditions not usually associated with permanent injury or death.” The FDA also advised that “Alternative medications that have a lower risk of oral clefts and other adverse birth outcomes should be considered for these patients.” At the same time, the FDA increased the pregnancy category of Topamax from C to D, which means there is positive human evidence indicating that the medication may cause significant harm to a developing fetus when taken during pregnancy.
July 2008 – In a study published in the medical journal Neurology, researchers find that “Exposure to the antiepileptic medicine Topamax in the first trimester of pregnancy carried a higher-than-usual rate of congenital malformations.”
July 16, 2012 – Researchers involved in a study published online by the American Journal of Obstetrics & Gynecology reports that use of Topamax during the first trimester of pregnancy was associated with an increased risk of oral clefts (cleft lip with or without cleft palate) in babies.
August 2012 – A study conducted by the American Headache Society finds a higher incidence of oral clefts and major congenital malformations among babies exposed to Topamax in pregnancy, compared with babies exposed to other anticonvulsant drugs.
Despite this alleged birth defect risk, 4.3 million people filled 32.4 million topiramate (Topamax) prescriptions in the United States between 2007 and 2010, and in May 2010, the makers of the anticonvulsant drug agreed to pay millions of dollars in fines for promoting Topamax for off-label uses not approved by the FDA, allegedly putting even more people at risk for birth defects and other injuries from the medication. Product liability lawsuits brought against Johnson & Johnson over alleged Topamax birth defects involve the following allegations:
Birth defects like cleft palate, cleft lip and hypospadias are not life-threatening, but they are likely to cause considerable complications for an affected child. Additionally, in treating and repairing these birth defects, victims and their families may incur overwhelming medical bills on top of the physical and emotional distress they have already endured. If you or a loved one has suffered from a birth defect which you believe to be caused by the use of Topamax in pregnancy, contact a Topamax attorney to discuss your legal options. Children born with cleft lip, cleft palate or hypospadias typically require reconstructive surgery in order to repair the defect and alleviate the side effects of the malformation. With an experienced Topamax lawyer on your side, you can pursue the financial compensation you deserve for your child’s injuries and medical bills.