According to the Food and Drug Administration (FDA), pregnant women taking the anticonvulsant drug Topamax may be putting their babies at risk. According to an FDA-issued warning, babies born to women on Topamax are 20% more likely to develop a deformity like a cleft lip. This is an especially critical warning for women of childbearing age who currently take Topamax for epilepsy and/or migraines. It’s also just one of several reasons that a Topamax lawsuit might be filed.
The FDA has asked doctors to tell patients who may get pregnant not to take Topamax. This is especially important in the first trimester, when a woman might not even know she’s pregnant. They also advise doctors to prescribe alternative medications to pregnant women, and to carefully watch their patients’ childbearing condition before prescribing Topamax to anyone.
The FDA also warns that women taking Topamax shouldn’t suddenly stop using it if they realize they’re pregnant. Patients should always talk to their doctor before voluntarily stopping the medication, as quitting all at once can pose risks to both the mother and her fetus. The FDA recommends that these women ask their doctor about other epilepsy drugs that won’t pose risks during pregnancy.
According to the FDA report, the first trimester is the most vulnerable period, when the fetus’ lip and palate do not fuse properly. The FDA urges women taking topiramate to also use effective birth control to prevent accidentally exposing a fetus to the drug. They also caution physicians that prescribing this anticonvulsant to those taking estrogen birth control pills could reduce their effectiveness and cause hormonal issues.
Topamax entered the market in 1996 and has since been known as an effective remedy for migraine and epilepsy. The drug (and its generic version, topiramate) is commonly prescribed to women, including those who are pregnant. For families wondering why their newborn babies have cleft lips, the FDA’s Topamax warning for pregnant women has raised major red flags. According to the FDA report, fetuses exposed to the drug were 1.4% more likely to develop oral defects.
After animal testing, Topamax was classified as a category C drug, meaning that it may cause decreased fetus weight, miscarriages, and birth defects. However, despite this categorization and other warnings, Topamax stayed on the market for human use. It took the FDA several years to recognize its link to cleft lips, which meant thousands of expectant mothers unknowingly exposed their fetuses to side effects.
In March of 2011, the FDA bumped Topamax up from a category C drug to a category D drug. This classification means that there is positive evidence of human fetal risk based upon human data. Category D drugs like Topamax can still be prescribed to certain patients in cases where the benefits outweigh the risks.
Brand name Topamax is made by Ortho-McNeil Neurologics. However, there are a number of generic manufacturers that make the drug since the original patent has expired.
Some manufacturers of generic topiramate include:
Drugs that negatively affect embryo formation are categorized as teratogens. With proper testing and appropriate warnings, these medications are still safe for those who aren’t pregnant. Unfortunately, like with Topamax, some drugs haven’t come with sufficient teratogen warning.
Other commonly prescribed drugs that have been associated with birth defects include:
In any case where a woman took Topamax during pregnancy and the child was born with a deformity, the manufacturers and marketers may have to pay damages. Current lawsuits against Topamax allege that the drug companies put their own profits ahead of babies’ health and safety by downplaying the risks of the drug. These are just the latest in a history of lawsuits.
In 2010, two Johnson and Johnson subsidiaries paid $81 million and pleaded guilty to misdemeanor criminal conduct for misbranding and illegally promoting Topamax. Though it was only approved for epilepsy, Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals, Inc. marketed it as a treatment for bipolar disorder, eating disorders, sleep disorders, obsessive-compulsive disorder, post-traumatic stress disorder, depression, obesity, smoking, and alcoholism.
Our firm spoke with a woman who had been taking Topamax to prevent migraine headaches. She did not plan to get pregnant at the time but had never been warned that Topamax could cause birth defects if she did. When she became pregnant, her doctor advised her to stop taking Topamax, which she immediately did. Unfortunately, the damage was already done.
The woman’s baby was born with a cleft palate deformity, but it wasn’t noticed at first. What was clear, though, was that the baby wasn’t gaining weight or staying nourished for the first several months. When the cleft palate was discovered later on, the baby’s feeding problems were no longer a mystery. Unfortunately, being malnourished early on may have already caused developmental disabilities. If there had been proper warning, these serious problems might have been avoided.
The admitted illegal marketing of Topamax is likely to be extremely significant in the current birth defect lawsuits. It serves as clear evidence that the drug companies may have been more concerned with making profits than people’s safety.
Another key point is the statistics from the North American Antiepileptic Drug Pregnancy Registry. According to their data, cleft lip and cleft palate occurred in 1.4% of infants exposed to topiramate alone in the first trimester of pregnancy. In contrast, the rate for infants exposed to other antiepilepsy drugs is only .38% to .55%. These numbers show that there are alternative drugs on the market that have a lower risk of birth defects and are preferable for certain patients.
It’s also significant that birth defects aren’t the only issues related to this drug. Damage to fetuses is the most documented and recognized issue, but many Topamax memory loss lawsuits, hair loss lawsuits, and kidney stone lawsuits have also been filed. Just like the birth defect cases, Topamax kidney stones lawsuits are backed by data. Research suggests that topiramate makes patients 2-4 times more likely to develop stones.
Parents of children born with any cleft lip or cleft palate deformity should contact a qualified attorney immediately if the mother took Topamax during pregnancy. There are limited time periods in which such a lawsuit can be brought, and the drug company has a strong chance of winning the case if it is not promptly filed in court.
Contact us today to discuss your experience and find out whether you have a case for a Topamax hair loss lawsuit, birth defect lawsuit, or other type of litigation.