Topiragen Birth Defects

Topiragen is one of a group of pharmaceutical drugs called anticonvulsants, which function by inhibiting the firing of certain impulses in the brain which cause seizure-related episodes. Topiragen was originally approved by the FDA in 1996 for the treatment of generalized tonic-clonic and partial onset seizures associated with epilepsy, and the FDA added an indication in 2004 for the prevention of migraine headaches. The active ingredient in Topiragen is topiramate, the same active ingredient as the anticonvulsant drug Topamax, and can be used alone as monotherapy or in combination with other anticonvulsant drugs to prevent epileptic seizures. The drug manufacturing company responsible for producing Topiragen is Upsher-Smith Laboratories, Inc.

Birth Defects

Despite the fact that topiramate-containing Topamax and Topiragen have become increasingly popular in the treatment of epilepsy and the prevention of migraines, recent research has identified the use of these drugs during pregnancy as a risk factor for the development of major birth defects among infants who are exposed to the medications in utero. Birth defects are internal or external malformations of the function or appearance of a child’s body part which occurs while the fetus is still in the womb. Many birth defects, including those potentially linked to the use of Topiragen while pregnant, are already established during the first trimester of pregnancy, which makes Topiragen use potentially dangerous for all women of childbearing age. Among the birth defects allegedly associated with Topiragen use are craniofacial birth defects like cleft palate and cleft lip, and genital birth defects like hypospadias.

Cleft Palate

Cleft palate is a malformation of the palate, or the roof of the mouth, which occurs between the fifth and sixth week of pregnancy. This craniofacial defect typically results from a lack of tissue in the palate area which prevents the roof of the mouth from fusing together completely in utero. A cleft palate can involve one or both sides of the mouth and the degree of the cleft can vary from a small opening at the back of the mouth to an almost complete separation of the roof of the mouth.

Cleft Lip

Cleft lip is a congenital defect involving the development of the child’s lip, the formation of which, under normal circumstances, is complete within five weeks after conception. A cleft lip is characterized by one or two vertical fissures in the upper lip which can range from a small opening in the lip to a significant crevice which can even extend up through the nose. This type of malformation is caused by a lack of tissue in the lip when the cells are fusing together during fetal development.

Genital Birth Defects

One of the genital birth defects potentially linked to the use of Topiragen is hypospadias, a congenital malformation in which the opening of the urethra in affected male infants is located on the underside of the penis, rather than at the end. Other symptoms of this condition include a downward curvature of the penis and a malformation of the foreskin which makes the penis look hooded. Individual instances of hypospadias can vary in severity from anterior, in which the urethral opening located is located near the tip of the penis, to middle, in which the opening is located along the midshaft, to posterior, in which the opening is located near the base of the penis.

Topiragen and Birth Defects

The FDA recently issued a safety announcement warning patients and healthcare providers about the increased risk of oral defects like cleft lip and cleft palate in infants whose mothers took Topamax (topiramate) during pregnancy. This announcement came after the review of data collected by the North American Antiepileptic Drug Pregnancy Registry which identified Topamax use during pregnancy as a risk factor for the development of craniofacial defects. According to the registry, the prevalence of cleft lip and cleft palate among infants born to women who took Topamax while pregnant was 1.4%, compared to the prevalence among infants whose mothers took other anticonvulsant drugs, which was 0.38-0.55%, and the prevalence among infants not exposed to any anticonvulsants, which was 0.07%.

A few years earlier, in 2008, the journal Neurology published a study with the goal of observing the adverse side effects potentially associated with the use of Topamax during pregnancy. The study involved 203 women who became pregnant while taking Topamax. Researchers determined that, of the 178 live births, sixteen infants were born with major defects. Three of the sixteen mothers took Topamax by itself while pregnant and thirteen of the mothers took Topamax in combination with another anticonvulsant drug. The infants born with birth defects included four infants with cleft lip or cleft palate, which represents a birth defect rate eleven times what would be considered normal, and four infants with genital defects like hypospadias, a rate fourteen times normal. Researchers also indicated that infants exposed to Topamax in combination with valproate, the active ingredient in Depakote, had an even higher birth defect rate.

Topiragen Use While Pregnant

The FDA has increased the pregnancy category of topiramate, the active ingredient in both Topamax and Topiragen, from C to D. This means that there is positive evidence of the drug’s potential to cause significant harm to a human fetus when taken during pregnancy. The FDA has advised physicians to avoid prescribing Topiragen to pregnant women unless all other treatment options have failed or the possible benefits of the drug justify the potential risks to the fetus. In the meantime, if you are currently taking Topiragen and you are pregnant or planning to become pregnant, consult your physician as soon as possible to discuss alternative treatment options.

A Topiragen Attorney Can Help

Birth defects like cleft lip and cleft palate can cause severe complications for an affected child, including frequent ear infections, hearing loss, feeding difficulties, speech and language delay, and dental issues like missing or misaligned teeth. Infants with hypospadias typically struggle with abnormal spraying during urination which may force them to sit down to urinate and, without treatment, can cause future complications like difficulty during toilet training and sexual intercourse later in life. If you or a loved one has suffered from a birth defect like hypospadias, cleft palate or cleft lip, and you believe the anticonvulsant drug Topiragen to be the cause, contact a Topiragen attorney to discuss your legal options. You may be entitled to reimbursement by filing a Topiragen lawsuit against Upsher-Smith Laboratories. The goal of potential Topiragen lawsuits and Topiragen class action lawsuits is to seek financial compensation for your injuries, medical expenses, and pain and suffering.

Victims of adverse side effects or birth defects allegedly associated with the use of potentially dangerous drugs are not at fault. Drug manufacturing companies are responsible for producing safe drugs and for notifying consumers of any adverse side effects potentially associated with their medications. Unfortunately, some pharmaceutical companies intentionally withhold dangerous drug information in order to ensure FDA approval and to make sure their drug garners positive attention from the public. This puts consumers unknowingly at risk of suffering adverse side effects on a daily basis, simply by taking their prescription medications. The only way to protect your rights and stand up to big drug companies is to hire an experienced Topiragen lawyer to represent your case.