Topamax (topiramate) is a popular prescription medication that was first approved by the FDA (Food and Drug Administration) to treat convulsions, epilepsy, and migraine headaches. However, by 2012, the FDA expanded their approval of the medication as an effective weight loss medication and to treat obesity. Doctors also prescribed Topamax for off-label use including to treat alcoholism, cluster headaches, and smoking cessation (to quit smoking).
However, there have been serious problems to babies exposed to the medication while in the womb during the developmental stage. Many children have developed specific congenital disabilities including cleft palate, cleft lip, and other malformations.
Rosenfeld Injury Lawyers LLC represents victims of medical malpractice and other types of professional negligence. Our law firm has successfully prosecuted cases for our clients whose children were born with congenital disability caused by the negligent actions of others. Our attorneys are available to answer any legal questions on how to receive the monetary compensation you deserve if your injuries were a result of a medical mistake or negligence. Should you have additional questions, we invite you to contact our office for a free review of your legal rights.
Topamax and Pregnancy
Women taking Topamax, a popular drug used to treat headaches and epilepsy, are more than three times more likely to give birth to a child with congenital disabilities related to a child's mouth such as cleft lip or cleft palate compared with women taking other brands of epilepsy drugs. Researchers estimate that infants born to women taking Topamax have a 1.4% chance of a having a congenital disability relating to their mouth.
Because of these safety concerns, the FDA now requires Johnson & Johnson, the manufacturer of Topamax, to incorporate stronger warnings about use during pregnancy. The federal regulatory agency began issuing warnings in 2011 of the serious risks associated with taking Topamax and pregnancy.
Topamax has been associated with congenital disabilities such as:
- Cleft lip
- Cleft palate
- Heart defects
- Facial deformities
- Deformed limbs
While some of these Topamax congenital disabilities were known by the medical community for years, the product's written warnings were inadequate for expectant mothers to make informed medical decisions. Moreover, there was no warning about Topamax's reduction in effectiveness in the oral contraceptives taken by women.
A study published in 1996, the same year the FDA approved Topamax for treatment for partial onset seizures, indicates that seizure medications– such as Topamax- may substantially increase the likelihood of a woman becoming pregnant while she is on birth control.
The net result of the inadequate Topamax warnings that many women were likely taking Topamax before they knew they were pregnant in the first place. Given the nature of fetal development, it is likely that many of the facial malformations and cleft palates are due to the mother taking Topamax during the vital first trimester when many of these features form.
Common Topamax (Topiramate) Side Effects
Topamax (topiramate) is no different than most prescription medications and that there are significant risks of developing severe side effects. The most common side effects associated with Topamax include:
- Slowed thinking and other cognitive changes;
- Mood changes expressed as high anxiety, nervousness, or depression;
- Insomnia or sleep pattern changes;
- Unexplained intense fatigue;
- Ataxia, the loss of full control of body movements;
- Alopecia (hair loss);
- Unexpected weight loss;
- Anorexia (a disease associated with loss of appetite);
- Unexpected changes in taste;
- Vision changes including double vision and nystagmus (uncontrolled, repetitive eye movement);
- Intestinal issues including diarrhea, stomach pain, upset stomach, nausea;
- Unexplained weakness and tremors;
- Urinary tract infections (UTIs), sinusitis, or other infections;
- Paresthesia including the abnormal sensation of numbness, pricking, tickling, and tingling;
- Altered or decrease sensations in the extremities;
- Mild to severe metabolic acidosis;
- Nephrolithiasis (kidney stones)
- Osteoporosis, osteomalacia (Vitamin D or calcium deficiency-associated bone-softening condition), and other bone density changes;
- Oligohidrosis (reduce sweating)
- Suicidal ideation;
- Psychotic episodes;
- Hyperthermia (increased body temperature);
- Hypokalemia (low potassium level);
- Anemia or leukopenia (changes in blood cell count's);
- Hyperammonic encephalopathy, a severe neurological disorder that might include right syndrome, hepatic encephalopathy, urea cycle enzymes, or another metabolic disorder or toxic encephalopathy;
- Visual problems including maculopathy, acute myopathy, and glaucoma;
- Neonatal cleft palate or cleft lip
- Delayed growth in children
- severe skin reactions including erythema multiforme, toxic epidermal necrosis, and Stevens-Johnson syndrome (SJS);
- Withdrawal-related seizures.
Topamax and the CDC
The CDC (Centers for Disease Control and Prevention) through its National Center on Birth Defects and Developmental Disabilities has taken effective steps at improving the health and well-being of women and their children. Their statistics show that 90% of all pregnant women take medications and wonder if they should discontinue its use until the baby is born. The federal agency states that:
“Almost every pregnant woman will face a decision about taking medicines before during pregnancy. However, not all medicines are safe to take during pregnancy. Some medicines may cause congenital disabilities, pregnancy loss, prematurity, infant death, or developmental disabilities.”
The CDC states that their studies “looked at the risk of oral cleft and infants with mothers took topiramate,” the generic version of Topamax, “during the first-trimester pregnancy.” The data “showed an increased risk of oral cleft and infants exposed to topiramate during the first trimester compared to infants not exposed to the antiepileptic medicines.” The federal agency revealed that it studies have linked “oral cleft and the use of topiramate during pregnancy. However, this association has been hard to evaluate because both the use of topiramate during pregnancy and the occurrence of oral clefts are rare.”
The CDC statistics show that approximately one out of 1000 children are born with a cleft lip (some or born with cleft palates too) in America every year. However, this number increases to five in 1000 infants if the fetus was exposed to Topamax (topiramate) while the mother was pregnant.
Topamax and the FDA
Statistics Maintained by the FDA (Food and Drug Administration) revealed that doctors gave over 32 million prescriptions of Topamax (topiramate) between January 2007 and December 2010 to treat more than four million patients.
In 2011, the FDA approved the use of Topamax (topiramate) to prevent migraine headaches. However, some doctors prescribe the medication off-label for the treatment of relieving pain associated with migraine headaches. That year, the federal agency began informing the public that studies have revealed the increased potential risk of birthing a newborn with an oral cleft (cleft lip and/or cleft palate) when the mother was receiving a Topamax (topiramate) treatment during pregnancy.
The government previously classified Topamax (topiramate) as a Pregnancy Category C medication, meeting that the information obtained through animal studies found that there were potential risks to the fetus; but there had yet to be adequate human clinical trials or studies made available when the FDA was considering the drug's approval. Since then, the medication has been downgraded to a Category Three status once new human study information revealed the increased potential risk of developing an oral cleft.
Because of recent findings, the FDA now recommends weighing the potential benefits of using the medication when pregnant that might be acceptable under specific situations even though there are identifiable risks. The FDA also states that:
“If you take topiramate during pregnancy, there is a higher risk that your baby will develop a cleft lip and/or cleft palate. Oral clefts happen early in pregnancy, before many women even though they are pregnant. For this reason, women of childbearing age should talk to their healthcare professional about other treatment options.”
“Women of childbearing age to decide to take topiramate and are not claiming a pregnancy should use effective birth control (conception) while takingZofran. Women should talk to their healthcare professionals about the best kind of birth control to use while taking topiramate.”
“If you become pregnant while takingZofran, you should talk to her health care professional about registering with the North American Antiepileptic Drug Pregnancy Registry.”
Women concerned about their health, while taking Topamax (topiramate) and want to register their use with the Registry, can contact them at (888) 233-2334. The Registry indicates that there is “an increased risk of oral clefts in infants exposed to [Topamax (topiramate)] model therapy during the first-trimester pregnancy.” The Registry also states that “The benefits and the risks of [Topamax (topiramate)] should be carefully weighed when prescribing the drug for women of childbearing age, particularly when [the medication] is considered for a condition not usually associated with permanent injury or death.”
Topamax Risks for Infants
Research has shown the damaging effects of SSRIs (selective serotonin reuptake inhibitors) used as antidepressants to treat anxiety disorders and depressive disorder. Many women who take Topamax (topiramate) while pregnant might be placing the child's health at risk. Studies have concluded that the medication might have a potential toxic effect on the baby while in the womb that can cause a developmental defect including a cleft palate or cleft lip. Other known congenital disabilities and health risks associated with taking Topamax (topiramate) include:
- Spina bifida
- Various heart defects
- Persistent Pulmonary Hypertension of the Newborn (PPHN)
- Lung defect
- Limb malformation
- Neural tube defect
Breast-Feeding and Topamax
Research studies have revealed the significant risks of breastfeeding a newborn while taking Topamax (topiramate) that could cause the child to suffer adverse effects. The drug is known to transfer to the newborn during breast-feeding, although in minimal amounts. However, when the medication enters the child's bloodstream, it can produce serious side effects that include:
- Poor feeding habits
Exactly how the newborn will react will be unique in every case. However, mothers taking the medication should weigh the obvious health benefits to the child against the associated risks and asked their doctor for recommendations on what to do to ensure the newborn remained safe.
Topamax (Topiramate) and Eye Problems
The anticonvulsant medication has been associated with severe eye disorders including secondary angle closure glaucoma and acute myopia. Without effective treatment for the discontinuation of the medication, both conditions can leave the patient (the mother or the child) with permanent blindness.
The disorder caused by Topamax (topiramate) affects children and adults in varying degrees. Some of the associated facts with Topamax -related issues include:
- The drug can cause acute myopia, a nearsighted visual problem where the individual can only clearly see nearby objects while distant objects are blurred.
- The medication has caused secondary angle closure glaucoma, where the angle between the cornea and iris start to close. This condition usually blocks the drainage canals which produce a sudden increase in fluid pressure in the eye's interior. This condition typically develops quickly and requires immediate medical attention.
Do I Have Topamax-Related Eye Problems?
There are obvious warning signs and indicators of the severe eye disorder that can develop within the first month after you start taking Topamax (topiramate). You should seek medical attention immediately if you experience pain surrounding your eye, a visual disturbance, or blurry vision. Some of the associated indicators of developing secondary angular closure glaucoma and acute myopia involve:
- Eye redness;
- Eye pain;
- Increasing fluid pressure in the eye's interior;
- Impaired vision where the site becomes less sharp and objects at a distance are no longer discernible;
- Fluid that builds up across the eyebrow that displaces the eye's iris and lens.
Our Legal Team Will Fight for You
The bad drug injury attorneys at Rosenfeld Injury Lawyers LLC understand that the serious side effects experienced by you or your child were not your fault. We have successfully obtained millions on behalf of the victims and their family members to ensure they were adequately compensated to cover their medical expenses, household bills, lost wages, loss of future earnings, pain, suffering, and emotional damage and we can help your family too.
Our legal team encourages you to contact our attorneys today to schedule a free, no-obligation case consultation to discuss the merits of your monetary recovery claim. We accept all personal injury cases, medical malpractice lawsuits, and defective medication injury claims through contingency fee arrangements. This legal contract postpones the payment of legal services until after we have successfully completed your case through a negotiated settlement or a jury verdict.
Our law firm gets results quickly because we understand you need money now. We proudly give every client a “No Win/No-Fee” Guarantee, meaning if we are unable to secure financial compensation on your behalf you owe us nothing. All information you share with our law office will stay confidential.
Related materials from Rosenfeld Injury Lawyers LLC:
- New FDA Warnings Suggest Correlation Between Topomax And Birth Defects Including: Cleft Lip & Cleft Palate
- More Evidence That Topamax Manufacturer Is Responsible For Birth Defects