Depakote Birth Defects May Depend on Dose

Stockholm, SwedenA recent study found that Depakote birth defects and such risks associated with other epilepsy medications may depend on the dose with which they are administered.

According to HealthDay, the study, which was conducted by researchers at the Karolinska Institute in Stockholm, Sweden, reportedly found that four of the five most typically prescribed epilepsy medications (including Depakote) increase birth defects risks. Additionally, they said the risk rose when the dosage was higher.

The news source reports that the researchers believed the study would help doctors to prescribe the best possible epilepsy drugs to pregnant women.

The drugs that were studied by the researchers included valproic acid (Depakote), phenobarbital, carbamazepine and lamotrigine, according to the news source. Despite the fact that the medications appeared to increase birth defect risks, the risks still appeared to be relatively low, they said.

According to the news source, the latest study departed from previous studies because it examined how individual dosage levels would affect the rate of birth defects. Additionally, prior research had not taken into account other potential confounding factors including family histories of birth defects.

"Present guidelines caution on the use of valproic acid during pregnancy, but offer little guidance on alternative options and how to manage women whose seizures cannot be controlled by other drugs," Dr. Torbjorn Tomson and colleagues said in a release.

The 11-year study examined nearly 4,000 pregnancies that occurred in 33 countries, with 230 of the pregnancies experiencing significant birth defects by the end of the child's first year of life, the authors said.

The latest indictment of Depakote involving birth defects comes as its maker, Abbott Laboratories, is currently in discussions to settle a government investigation over allegations that it illegally promoted the medication, according to the Dow Jones Newswires.

The news source reports that the US Justice Department said in a recent court filing that the two parties were "engaged in active settlement discussions."

The Justice Department is reportedly investigating whether or not the drugmaker violated any laws when it marketed Depakote as a treatment for cases of aggression and agitation in elderly patients, as well as other uses that have not been approved by the US Food and Drug Administration, the news source said.