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:
Topamax is one of a group of prescription drugs called anticonvulsants, which are typically prescribed to individuals suffering from epileptic seizures. The active ingredient in Topamax is topiramate, and the drug functions by interfering with the firing of certain impulses in the brain responsible for causing seizures. The FDA originally approved Topamax in 1996 to treat primary generalized tonic-clonic seizures and partial onset seizures associated with epilepsy, and in 2004, the FDA added an indication for Topamax in reducing the frequency and intensity of migraine headaches in adults. Some physicians also prescribe Topamax for off-label purposes like the treatment of obsessive-compulsive disorder, neuropathic (nerve) pain and bulimia nervosa.
Since its inception, Topamax has become one of the most commonly prescribed anticonvulsant drugs on the market in the United States. However, recent studies have suggested that women who take Topamax during pregnancy may significantly increase their risk of giving birth to babies with major birth defects. Some of the congenital malformations allegedly associated with the use of Topamax during pregnancy include oral clefts like cleft lip and cleft palate, and genital birth defects like hypospadias.
Cleft lip is a craniofacial defect involving the malformation of a child’s upper lip in utero. During normal fetal development, the child’s lip is fully formed after the first few weeks of gestation. However, when there aren’t enough cells in the lip area during this time, a child’s lip may fail to fuse together completely and a cleft lip may occur, characterized by a vertical fissure on one or both sides of the upper lip. Children born with a cleft lip typically suffer from a number of complications, including speech and language delay, feeding difficulties, chronic ear infections, hearing loss, and missing or malformed teeth.
Cleft palate is a congenital birth defect similar in nature to a cleft lip, but involving a child’s palate instead. A cleft palate occurs when there aren’t enough cells in the palate area as the roof of the mouth is forming in utero, and can affect the soft back portion of the mouth or the bony front portion of the mouth. Infants born with a cleft palate often struggle with additional issues, including feeding difficulties, recurring ear infections, hearing loss, missing or misaligned teeth, and speech and language delays.
Hypospadias Genital Defects
Hypospadias is a type of genital birth defect in which the opening of the urethra is located on the underside of the penis, rather than at the end. In less serious instances, the opening may be located near the end of the penis, while more severe cases may present with the opening located at the mid-shaft or base of the penis, or even in or behind the scrotum. Unfortunately, children born with hypospadias who do not receive treatment often struggle with significant difficulties, including problems with toilet training and during sexual intercourse later in life.
The FDA has elevated Topamax to a pregnancy category D because of the potential for babies exposed to the drug to develop serious birth defects. This decision was made by the FDA based on new data collected by the North American Antiepileptic Drug (NAAED) Pregnancy Registry, which indicated that babies whose mothers took topiramate (Topamax) during pregnancy had a 20-times increased risk of being born with cleft lip or cleft palate, compared to babies whose mothers did not receive anticonvulsant treatment while pregnant. According to the registry, 1.4% of infants whose mothers became pregnant while taking Topamax were born with an oral cleft, while the rate among infants exposed to other anticonvulsant drugs was 0.38-0.55%, and the rate among unexposed infants was only 0.07%.
In 2008, the journal Neurology published a study indicating that infants exposed to Topamax in utero were 14 times more likely to develop genital defects like hypospadias, and 11 times more likely to be born with cleft lip or cleft palate, compared to unexposed infants. Researchers involved in the study reviewed 178 infants whose mothers became pregnant while taking Topamax, and indicated that 16 were born with birth defects. Three of the 16 infants were exposed to Topamax alone in utero, and 13 were exposed to Topamax in combination with other anticonvulsant drugs. Of the 16 affected infants, four were born with cleft lip or cleft palate, and four were born with genital birth defects like hypospadias.
2009 – The Department of Justice accuses J&J subsidiaries Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals Inc. of promoting Topamax “off-label” to doctors for uses not approved by the FDA. The drug makers plead guilty to the charges and agree to pay a $6.14 million criminal fine and $75.37 million fine for violating the False Claims Act.
October 31, 2013 – Janssen Pharmaceuticals faces 134 lawsuits filed in Philadelphia court, on behalf of women who took Topamax during pregnancy and gave birth to a baby with a congenital malformation. A jury awards $4 million in damages in the first lawsuit, after finding Janssen liable for failing to warn consumers about the risk of Topamax birth defects.
March 10, 2014 – A Pennsylvania jury awards $3 million in damages to the family of a five-year-old boy who was born with a cleft lip birth defect after his mother took Topamax during pregnancy to treat migraine headaches.
March 16, 2015 – An $11 million jury award delivered in a lawsuit filed by the family of a boy born with a cleft lip birth defect survives an appeal by Janssen.
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.