Antiseizure drugs and Suicide/Birth Defects
Numerous recent reports link the use of anti-seizure mediations such as Depakote (sodium valproate and valproic acid), Neurontin (gabapentin) and Tegretol (Carbamazepine) with suicide and birth defects, including heart defects, brain damage, and mental retardation. According to one study, infants exposed in the womb to Depakote had twice as many birth defects as would have been expected.
The U.S. Food and Drug Administration (FDA) has also received reports about the increased risk of suicidality (suicidal thinking and behavior) in people treated with these medicines. Because of these reports, the FDA is investigating whether epilepsy drugs increase the risk of suicidal behavior in some patients, especially those who are prescribed the medications for psychiatric illnesses and not seizure prevention. Prescribing medication for unapproved conditions is called "off-label" use, and may create increased risks for patients.
On January 31, 2008, the FDA issued a warning to Health Care Professionals of an "increased risk of patients having suicidal thoughts and behaviours as a result of taking antiepileptic drugs for epilepsy, bipolar disorder, migraines, and other conditions."
Such warning was based upon data collected by the FDA which showed that upon review of placebo controlled studies of eleven antiepileptic drugs, "patients who took them had two times the risk of suicidal thoughts and behaviours (suicidality) of patients who took placebo only (0.43 versus 0.22 per cent)."
In 1994, Gabapentin, (also marketed as "Neurontin") was approved by the FDA for the treatment of epilepsy. Neurontin during the next years was actively promoted for off-label and unapproved uses such as pain, neuropathy, restless leg syndrome, depression, and bi-polar disorder.
In fact, on May 16, 2004, Pfizer, Inc., the manufacturer of Neurontin agreed to a settlement of $480 million dollars in both criminal and civil claims, as a result of its off-label promotion of the medication.
There are presently hundreds of cases pending before the United States District Court of Massachusetts and the Supreme Court of New York.
Valproic acid, a well known anticonvulsant, is being used by psychiatrists increasingly to manage bipolar and other affective disorders. Because of the demographics of the population affected by such psychiatric conditions, more women of childbearing age are likely to be exposed to this teratogenic (birth defect-causing) drug.
Neural tube defects (NTD) are the most common of the major anomalies associated with in utero valproic acid exposure, and are estimated to occur in 1% to 2% of exposed fetuses.
Other teratogenic effects (birth defects) include:
- facial dysmorphism
- congenital cardiac defects
- limb reduction defects and other skeletal anomalies
- spina bifida
- cleft palate
Psychiatrists should be aware of the teratogenic potential of Depakote / valproic acid and know how to counsel their patients of reproductive age.
see http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1188938/
At Pogust Braslow & Millrood, protecting our clients is our primary goal. We recognize that drug companies are under an obligation to warn about the known risks of their products. When they fail to do so, they may be held responsible for the injuries or deaths that are the consequence of their inaction. In addition, doctors may be responsible when they prescribe a medication for an unapproved condition and the patient suffers a serious side effect.
If you or your child has attempted suicide, a loved one has committed suicide, or a child has been born with a birth defect while the patient was taking an anti-seizure medication, you should immediately contact the attorneys at Pogust Braslow & Millrood, where Protecting Consumers Is Our Primary Goal. Just fill out this form, click here to send us an email or call us at (610) 941-4204.
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