FDA Warns Against Drugs Containing Valproate
The Food and Drug Administration has recently issued a warning against drugs containing valproate, a common ingredient in medication to alleviate migraine headaches, epileptic seizures and treatment of bipolar disorder. Pregnant women who consume these drugs run the risk of their children developing lower IQ scores by the age of six.
The warning comes in the wake of a recent study by the National Institutes of Health and the United Kingdom Epilepsy Research Foundation, which confirmed that pregnant women who had consumed medication containing valproate had children whose IQ levels were about eight to 11 points lower than their peers. The study shows that these children consistently displayed a substantial decline in developmental abilities.
Many common drugs used for migraine headaches, such as Depacon, Depakote and Stavzor, contain valproate sodium, valproic acid, and divalproex sodium. These drugs alleviate migraines, and their benefits have been said to far outweigh the damages they cause. Drugs containing valproate, were thus far, “Category D” drugs, which meant that while there is evidence of risk to the fetus, the drug’s potential benefits outweigh the risks for their intended use. Such drugs already carry a boxed warning for birth defects.
The FDA has now placed drugs used for migraine treatments, containing valproate, in “Category X,” which indicates that the drug’s risks now outweigh the drug’s benefits. However, drugs used to treat epileptic seizures and bipolar disorders, containing valproate, remain under Category D.
The re-classification, however, does not absolve the manufacturers of the responsibility for damages caused, especially if you have children who have already suffered ill-effects as a result of the consumption of this drug during pregnancy. Depending on the circumstances, such as whether the drug was avoidable yet still prescribed to a pregnant woman by her medical practitioner, the ability to sue for damages still exists. Wagner Reese’s team of skilled Indiana drug injury attorneys are your best choice to attain justice and claim compensation. We have considerable experience with these types of cases, and delivering sizable compensation to victims.
Contact us at (888) 204-8440 for more information and a free consultation on your case!