Depakote Birth Side Effects Need Further Review: FDA Officials
Published: June 23rd, 2009 • Comments: 7
FDA researchers are requesting that the agency take a closer look at Depakote side effects for pregnant women, to examine whether there is a link between the anti-seizure medication and developmental delays in children born to mothers who took the drug.
The recommendations come before an FDA advisory panel meeting scheduled for today to review the impact of a number of drugs on children.
For Depakote (divalproex), staff drug reviewers at the FDA identified six cases of children born with delayed development after their mothers took the drug during pregnancy, including several children who developed autism. They indicated that further research is needed to examine whether there is a direct causal relationship and the degree of risk of fetal exposure to the medication.
Depakote was created by Abbott Laboratories and is currently available as generic divalproex from several manufacturers. It was first introduced in 1983 and is approved to treat epilepsy, mania associated with bipolar disorder and migraines.
A “black box” warning has been on the medication’s label since 2006, warning about potential Depakote birth defects associated with use of the drug during pregnancy. A study done that year found that about 20% of babies born to mothers taking Depakote suffered serious problems, as opposed to other drugs which only had rates of between 1% and 10.7.
FDA researchers now indicate that the agency should also investigate the drug for ties to developmental problems such as autism. Although the limitations in the reported problems make it impossible to definitively conclude that there is a connection between Depakote and developmental delay, the staffers called for the FDA to commit more resources to exploring whether such a link exists.
Earlier this year, the American Academy of Neurology and American Epilepsy Society issued guidelines that urged pregnant women to avoid taking epilepsy drugs that include valproates, due to an increased risk of birth defects such as cleft palate and spinal bifida. Depakote becomes valproate once it has entered the body. The guidelines also recommended that women avoid taking more than one epilepsy medication at a time.
Comment by Amanda on 17 July 2009:
I have been on depakote since I was 14. Iam 31 now I have 2 kids that have lots of problems. My son is 13 know at birth he only weighed 4lbs 7oz and was in the hospital for 2 weeks.He has problems with his memory and has to take adderoll 25mg My Daughter is 10 and has epilepsey and all of her teeth are discolored.She is also slow she is in a ESE class in school and has to wear hearing aids.She also has a speech problem. I have allways felt that Depakote has had something to do with my kids problems.My daughters nerologists said that he thinks it had alot to do with everything.I would not advise anyone pregnant or going to start a family to be on this medication it’s horrible.
Comment by Marsha on 2 September 2009:
I was 17 when I got pregnant with my daughter. I was under a doctors care for epilepsy and on Depakote! The last 18 years have been tough. We were in and out of counseling, psychologist, child psychiatrists, numerous medications and diagnosis, tons of missed school and work. She has developmental problems, wore hearing aids, was in special classes and had difficulties with peers due to her developmental differences. I’m currently working on getting my medical records. She turns 18 this month and my fear is that she cannot function effectively as an adult.
Comment by Mandy on 6 October 2009:
I was prescribed depakote by my neurologist during my pregnancy with my first son. He has been diagnosed with fetal valproate syndrome, and autism. He received developmental therapy, occupational therapy and speech and language therapy age 1 to 3. Currently he is in an Early Childhood class, also receiving occupational therapy and speech and language therapy. My hope is that doctors will no longer prescribe depakote to women who are pregnant or plan to become pregnant. The side effects are devastating!
Comment by Michelle on 16 October 2009:
I have been on Depakote since I was 11 and I am now 30. My son is now going on 3 years old and says maybe 10 words, now of them in a communicative manner. He goes to speech therapy twice a week and is still not able to communicate with his family. He will be evaluated for autism at the end of the year because he demonstrates so many autistic traits at this point.
Comment by Jodi on 19 October 2009:
I was on Depakene when I was pregnant with my daughter in 1981. My daughter was born with a number of problems. She spent 10 days in the NICU. She was born with a syndactaly on her left hand and has had 8 surgeries throughout her life so far & will more than likely need more. She also had a weakness on one side to the point that they thought she had Cerebral Palsy. She had a hip click & had to wear a brace as an infant. She also had a heart murmur.
Comment by barbie on 18 November 2009:
i first started depakote when i was nineteen and have had two children one while i was on it and one without my daughter has no delays and my son who i was pregnant and taking it has had many delays he is going to be three says about five words has also had weekness on one side of his body has had delays in all areas and also displays autistic behavior i believe along with the other stories i have read on here it is due to depakote anyone have any info on the lawsuit please leave a comment
Comment by ileata on 18 January 2010:
My 16 yr old daughter had problems and was sent to Richard Young hospitol and prescribed Depakote for depression , She ended pregnaut and her attending doctor left her on this medication , Well my grandson is 5 now has problem with speach and he writes letters backwards, he has had health problems including a heart murmur , would like to find out about this lawsuit thanks