The National Institute of Neurological Disorder and Stroke (NINDS) estimates epilepsy affects one percent of the United States population, or 2.5 million people. The Epilepsy Foundation states approximately 1.1 million women with epilepsy in the U.S. are of childbearing age. About 24,000 babies are born to women with epilepsy every year, which is a birth rate of 3-5 per 1,000 births. The majority of women with epilepsy give birth to normal, healthy children.
The personal injury lawyers at Parker Waichman LLP have decades of experience representing clients in drug injury lawsuits. The firm offers free, no-obligation legal consultations.
Birth Defect Risks and Anti-epileptic Drugs
Some anti-epileptic drugs (AEDs) are associated with birth defects, so the question is raised, why would a pregnant woman, or a woman who may get pregnant, be prescribed an AED? Some women do not realize they are pregnant until late in their first trimester or even into their second trimester. This period of time is when a baby’s organs are developing, as well as the time when the majority of fetal malformations may occur.
Epileptic women in particular, may not be aware of their pregnancy at the earlier stages as, according to the American Pregnancy Association, the symptoms of epilepsy are similar to those of pregnancy.
The risk of seizure declines or stays the same, fortunately, for most women during pregnancy. However, there are seizure risks that include trauma from falls or burns, miscarriages, premature labor, and lowering of the fetal heart rate. Certain anticonvulsant medications more than others, may have side effects that increase the risk of birth defects.
Differences Between Older and Newer Generation Anticonvulsants
Over 20 different AEDs are available, and some of the newer anticonvulsants are better tolerated than the older AEDs. Some anti-seizure medications have a higher incidence of birth defects, such as valproate (brand name Depakote), which is considered to be the riskiest. If valproate is taken in the first 28 days of pregnancy, there is a one to two percent risk of neural tube defects or lack of spinal cord closure.
Research from the Neurodevelopmental Effects of Anti-epileptic Drugs (NEAD), found that women taking valproic acid during pregnancy gave birth to babies that developed a lower than average IQ. These children may have an average of 92, which is six points lower than average, as well as an increased risk of autism. Depakote also raises the risk of spina bifida and other structural deformities to approximately 10 percent.
When compared to Depakote, the newer generation AEDs, including Lyrica (pregabalin), are safer, and better tolerated, than the older generation of anti-epileptic drugs, such as phenobarbital and valproate. But, only a few studies have compared the newer to older generation medications and they have not included comparisons of birth defects linked with the drugs. On the study’s safety profiles and adverse effects, Lyrica had better results than other anticonvulsants.
Newer Generation Drug Lyrica
Lyrica is classified as a miscellaneous analgesic and anticonvulsant. It was approved in 2004 for “the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) and post-herpetic neuralgia (PHN), (pain following or accompanying the condition known as shingles), and as adjunctive therapy for adults with partial onset seizures. Neuropathic pain is chronic pain that arises from damage to sensory nerves, such as pain from trapped or compressed nerves, drug-induced nerve damage, phantom limb syndrome subsequent to limb amputation, and fibromyalgia.
In 2009, the U.S. Food and Drug Administration (FDA) issued a warning to physicians, advising they recommend that pregnant women taking Lyrica enroll in the North American Anti-epileptic Drug (NAAED) Pregnancy Registry. To patients, the FDA said, “they should be encouraged to enroll in the NAAED Pregnancy Registry if they become pregnant.” So, in actuality, the FDA warning label for Lyrica does not specifically warn pregnant women not to take the medication. It only cautions them to consult with a doctor if they are pregnant or plan to become pregnant. With the knowledge that Lyrica may cause birth defects, it appears that the FDA warning is not strong enough.
Lyrica remains one of Pfizer’s top selling drugs. It generated $5.1 billion in revenue in 2014. However, before taking pregabalin (Lyrica), a doctor or health care provider should be consulted if any of the following are present: heart problems, (such as congestive heart failure, irregular heartbeat), high blood pressure; muscle problems; diabetes or bleeding problems; kidney problems; a history of mental problems (such as depression), suicidal thoughts, alcohol or drug abuse; a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue, difficulty swallowing or breathing).
A study in Norway discovered that pregnant women with epilepsy had less of a risk of complications, but an increased risk of induction (inducing labor), cesarean delivery, and postpartum hemorrhage. The study did not conclude if the increased risks were a result of anticonvulsant medications or severe epilepsy. However, one thing is clear: both seizures and medicines are associated with a degree of risk and the benefits of medications must be weighed very carefully.
Legal Help and Advice Concerning Birth Defects due to Drugs
Attorneys at Parker Waichman LLP are highly experienced in drug injury lawsuits. If you or someone you know has been negatively affected by medication, you may be entitled to valuable compensation. We urge you to contact the Parker Waichman personal injury attorneys at 1-800-YOURLAWYER (1-800-968-7529).