Pewaukee, WIIn October 2006, the FDA approved safety labeling changes for Depakote. It warns that Depakote can cause harm to an unborn baby, particularly in the first trimester, and not to use Depakote without your doctor's consent if you are pregnant. For one new mother, the warning may have come too late.
Tara Devereaux was taking Depakote and the birth control pill, so it didn't occur to her that she could get pregnant - until her seventh week. "My daughter was born January 18th, 2007 with a heart murmur and hypertension, which we now realize our regular problems in infants conceived while the mother was taking Depakote," says Devereaux.
"I was under a psychiatrist's care last year and was prescribed Depakote for about six months. I had depression and anxiety and a mild case of OCD. I was never diagnosed as bipolar and never had convulsions or migraine," she says. Depakote is only supposed to be prescribed for convulsions, bipolar disorder and migraines.
"My pregnancy was an unwanted surprise but as soon as I found out, I discontinued the drug. Unfortunately, I was almost two months pregnant," Devereaux says.
"I had a normal delivery, but Matilda was born with high blood pressure and a heart murmur so the day she was born, they transferred her to Children's Hospital. I had to stay behind; it was devastating to have her taken away and I was so worried. She was at Children's for five days. All I knew was that she had these two things wrong with her. They did a lot of tests including a sonogram on her kidneys. They also had no answers for me.
My husband did some research online about Depakote and found out that there are scores of women who are in the same situation as me - their baby was born with medical problems like mine, mainly these two symptoms. Lots of women also say they became pregnant while on birth control and Depakote. In my case, getting pregnant was like a shot in the dark - I am not that fertile."
With their flagrant off-label usage, maybe Depakote will market itself next as a fertility drug! Devereaux says to take her advice if you are trying to get pregnant: stop a few months ahead of time; it takes at least a month for this drug to leave your system.
"Matilda has a nurse visit once a week to check her blood pressure and I have an appointment with a cardiologist and a renal specialist. (I also have a four-year-old and he is an extremely healthy child - I wasn't taking any meds when I was pregnant with him.) They told me that she might outgrow the heart murmur but it's still too early to tell. She is taking drugs for high blood pressure," she says.
"Even though she is doing okay now, I am extremely concerned - no parent wants their kid to have life-long health issues, especially if it was caused by something I was taking, something prescribed to me by a health professional.
I am furious with my psychiatrist. Why didn't he know more about this drug before prescribing it? And Abbot has shown a complete lack of responsibility by not informing the medical community."
Depakote (generic name valproic acid, divalproex) is an oral drug used in the treatment of convulsions, bipolar disorder and migraines.
On October 13, 2006, the FDA approved safety labeling changes for divalproex sodium delayed-release tablets, extended-release tablets, and sodium-coated particles in capsules (Depakote, Depakote ER, and Depakote sprinkles, made by Abbott Laboratories, Inc). The warning advises of adverse risks associated with their use during pregnancy and it also states that women "of childbearing potential" should take this drug only if it is "essential for the treatment of their medical condition," and that the potential risks and benefits should be carefully weighed with the patient.
Long before 2006, there were reports in clinical literature indicating that the use of anti-epileptic drugs during pregnancy results in an increased incidence of birth defects. Depakote is an antiepilepsy drug; why was it prescribed to a woman with anxiety attacks?
According to data reported by the North American Antiepileptic Drug Pregnancy Registry, use of about 1 g/day of valproic acid monotherapy during the first trimester of pregnancy is linked to a 4-fold increased risk for congenital malformations compared with other AEDs as a group (odds ratio, 4.0; 95% confidence interval [CI], 2.1 - 7.4).
Depakote Prescribed to Toddler
On December 13, 2006, four-year-old Rebecca Riley died from a lethal dose of Valproic acid, also known as Depakote. The coroner said that Dextromethorphan, a cough suppressant, and Chlorpheniramine, an antihistamine, were also found in the girl's system. At 2 ½, she was diagnosed with ADHD and bipolar disorder.
Meanwhile, Abbot Laboratories reported on January 24, 2007 that in their last quarter, Depakote sales jumped 15% to $405 million. Could that have something to do with off-label prescriptions?
If you or a family member have taken Depakote and have subsequently had a child with birth defects, please contact a [Depakote] lawyer who will evaluate your claim at no charge.