The Maryland-based National Neurovision Research Institute and the U.S. Defense Department have been collaborating on a multi-state clinical trial designed to evaluate how effective valproic acid is in slowing and reversing the compromised vision function that is suffered by patients with autosomal dominant retinitis pigmentosa.
The U.S. Food and Drug Administration approved valproate products such as Depakote “to treat seizures, and manic or mixed episodes associated with bipolar disorder (manic-depressive disorder), and to prevent migraine headaches. They are also used off-label (for unapproved uses) for other conditions, particularly for other psychiatric conditions.”
Researchers are recruiting participants for an experiment expected to yield its primary results in March 2014.
Pregnant women justifiably are not among the recruited. Moreover, according to a U.S. National Institutes of Health summary, “Female subjects of childbearing potential and male subjects able to father children must have (or have a partner who has) had a hysterectomy or vasectomy, be completely abstinent from intercourse or must commit to practice at least two acceptable methods of contraception to minimize the chance of pregnancy during the study and for the 13 week period after stopping the study drug. … Female subjects of childbearing potential must have a negative urine pregnancy test at study entry and throughout the duration of the study.”
One reason this important research is deemed irreconcilable with pregnancy is that there is an increased risk of birth defects in babies born to mothers who took valproate products, one of which is Depakote (divalproex sodium).
The association between taking the drug and giving birth to a child who has birth defects would have been valuable information to a generation-long span of pregnant women and women of childbearing age. Unfortunately, many patients whose children suffered Depakote birth defects did not know. Depakote lawsuits have been filed in pursuit of well-deserved compensation for the drug’s victims.
The FDA in 2009 warned against the use of Depakote and other valproate products during pregnancy because of the increased risk of serious neural tube birth defects, such as spina bifida, and other major congenital abnormalities.
The FDA also reported “the results of epidemiologic studies that show that children born to mothers who took valproate sodium or related products throughout their pregnancy tend to score lower on cognitive tests (IQ and other tests) than children born to mothers who took other anti-seizure medications during pregnancy.” Consistent with that finding, the FDA announced in June 2011 that it would revise the labels on all valproate products to reflect “the risk of impaired cognitive development in children born to mothers who took valproate sodium or related products during pregnancy.”
Women who took Depakote and who were either pregnant or capable of becoming pregnant should have known what valproate researchers now know. The medication, however, was introduced into the market in 1983, long before patients learned about the heightened risk of Depakote birth defects that the manufacturer, Abbott Laboratories Inc., should have known and should have informed regulators, the medical profession and the general public about.
Victimized families need all the help they can get as they deal with the day-to-day challenges and face medical expenses that can exponentially increase, depending on the treatment. In many situations, they need an effective Depakote litigation team on their side to fight for them.
A woman who took Depakote during pregnancy and whose child suffers from birth defects may want to contact one of the experienced pharmaceutical personal injury attorneys at Reich & Binstock. A national law firm, Reich & Binstock has nearly 30 years of experience in personal injury law and a laudable track record in pharmaceutical litigation.
Reich & Binstock’s Depakote attorneys will do a case evaluation free-of-charge and advise victims of their legal options, which may include the filing of a Depakote lawsuit in the pursuit of recoverable damages. Reich & Binstock operates in all 50 states. One may call the law firm and set up a free consultation toll-free at 1-866-LAW-2400.