Depakote Birth Defects Versus Seizures

Portland, ORBeverly says she felt stuck between a rock and a hard place when she was taking Depakote and became pregnant. But after her son’s Depakote birth defects became apparent, Beverly thinks she made the wrong choice.

“My doctor advised that I stay on Depakote during my pregnancy and just lower the dose because having a seizure was too risky for me and my unborn child,” Beverly (not her real name) explains. “I took his advice up to a point: I slowly weaned myself off the drug so I wouldn’t have a seizure and stopped taking Depakote completely by the time I was 16 weeks pregnant. But the damage had already been done.”

Beverly’s son was born with a cleft palate and lip. Just before his first birthday she noticed that his eye “kept crossing” so her pediatrician set up an appointment with an eye surgeon. “He was sedated for a CAT Scan, which showed optic nerve hypoplasia (ONH). The American Association for Pediatric Ophthalmology and Strabismus says that ONH is associated with maternal diabetes, maternal alcohol and drug abuse, and young maternal age (20 years of age or less) and maternal use of anti-epileptic drugs. Beverly is in perfect health and had her son when she was 30 years old.

“We patched his eye, hoping it would help strengthen the bad eye, but the doctor is pretty sure he is blind in that eye,” says Beverly. “We recently got him prescription glasses to protect the good eye, but he is facing surgery. There is a slim chance that his vision may improve slightly in the next few years so we are going to wait. And the doctor said that his eye will likely turn back in. I try not to beat myself up thinking about Depakote but it’s almost impossible not to. My son is my reminder. If only I trusted my instinct and stopped taking it as soon as I found out that I was pregnant. But even if I did stop then, perhaps these birth defects happened before I knew…I talked to my pediatrician and my family doctor: no one has a definitive answer. But my pediatrician did say that Depakote was likely linked to his birth defects.

To make matters worse, I went on another, safer anti-seizure medication that has no association with birth defects. And I haven’t had a seizure since before my son was born.”

The FDA has warned that valproate sodium (Depakote) and related products, valproic acid and divalproex sodium, are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches. It hasn’t gone so far as to say the drug should be discontinued if it is used to prevent seizures.

Depakote Litigation

Abbott Laboratories, the maker of Depakote, faces a number of lawsuits alleging its anti-seizure medication resulted in birth defects (In re: Abbott Laboratories Inc., case numbers 12-8020, 12-8021, 12-8022, 12-8023, 12-8024, 12-8025, and 12-8026, in the U.S. Court of Appeals for the Seventh Circuit).

A lawsuit claiming illegal marketing practices (Re Abbott-Depakote Shareholder Derivative Litigation, 11-cv-08114, U.S. District Court, Northern District of Illinois) has also been filed against the drugmaker. In June 2013, a request from Abbott shareholders to dismiss the lawsuit was denied. Eight lawsuits have been consolidated into a single case against Abbott Laboratories’ directors, who are accused of violating their financial and management responsibilities. By August several more claims were filed against Abbott including three health plans that accused the drugmaker of scheming to make millions off payments from off-label marketing through reimbursements. One plaintiff further claims its members were encouraged to order Depakote when less expensive, more effective alternatives existed on the market.

Beverly knows from experience that an alternative anti-seizure medication is available.