Depakote Studies Need Cautionary Notes for Pregnant Women

July 27th, 2010. By janem

Some reports put Depakote in a more favorable light over other epilepsy drugs because there isn’t an increased risk of self-harm of suicidal behavior as reported in similar epilepsy meds. But such reports can also be dangerous if read by a soon-to-be pregnant woman or worse, an already pregnant woman on Depakote, because they often neglect to mention that the drug has been linked to Depakote birth defects.

Or perhaps a physician will read these reports and focus only on Depakote and its link to depression, bypassing its association to birth defects.

For instance, a recent UK study (Neurology, July 27, 2010) revealed that those who took relatively new antiepileptic drugs with a higher risk of causing depression, (such as levetiracetam (Keppra), topiramate (Topamax) and vigabatrin (Sabril) were three times more likely to harm themselves or attempt suicide than those who weren’t taking any epilepsy medications. The researchers found that patients who took conventional epilepsy medications, such as divalproex (Depakote, Depakote ER, Depakene) faced no increased risk of self-harm of suicidal behavior.

The Journal of the American Academy of Physician Assistants (July 29, 2010) reported that Depakote, when used as a mood stabilizer in adults with acute bipolar depression, decreases depression symptoms by at least 50 percent in at least one additional patient of every 10 patients who are given treatment instead of placebo. Again, no cautionary words for pregnant women.

Perhaps such studies should list alternative anti-epileptic medications.

But two studies presented at the beginning of July –the UK Epilepsy and Pregnancy Register and the European and International Registry of Antiepileptic Drugs in Pregnancy (EURAP)– found that Depakote and other valproate-based antiepileptic drugs were more than twice as likely to cause major congenital malformations when used by pregnant women than Tegretol (carbamazepine) and Lamictal (lamotrigine), with an overall risk of more than 6 percent.

The EURAP study set the odds of a Depakote birth defect at 9 percent. While those odds sound risky, a study done in 2006 found that about 20 percent of babies born to mothers taking Depakote suffered serious problems, as opposed to other drugs which only had rates anywhere between 1 and 10.7 percent. (Depakote was slapped with a black box warning in 2006). Clearly, the risk of Depakote outweighs the benefits, when it comes to the possibility of a pregnant woman suffering a seizure. After all, there are alternative and much safer medications.

Tags: depakote, depakote birth defects, depakote pregnancy, depakote side effects

This was posted on Tuesday, July 27th, 2010 at 1:43 pm and is filed under Drugs/Medical . Feel free to respond, or trackback. Read our comments policy.