MADRID – The risk/benefit balance is a tough one when it comes to women who become pregnant while they’re taking antipsychotic medication. Data are sparse on safety during pregnancy and lactation, but there are cases of women with stable mental disorders who rapidly deteriorated after being taken off their medication because of concern about a developing fetus.
In fact, Dr. Jayashri Kulkarni said, a patient with whom she was involved experienced this very thing, and her case was the impetus for creating the National Registry of Antipsychotic Medications in Pregnancy (NRAMP).
"The background of the project is a very sad one," she said, describing the case of a 28-year-old woman with schizophrenia who had "lived a zombielike life" on typical antipsychotics, until she began taking first risperidone and then olanzapine. Her symptoms abated and cognition improved so that she was able to work as a sales assistant. She became involved in a 2-year relationship with a coworker, and then became pregnant.
"Her general physician said there were no safety data on the drug and took her off it," Dr. Kulkarni said. Within 2 weeks, the patient’s auditory hallucinations returned. At 20 weeks’ gestation, she attacked a customer and was fired from her job. At 28 weeks, she was involuntarily admitted after attempting to slash her abdomen in response to the voices’ commands to destroy "the alien" growing in her. At that point, her partner forbade her to return to their apartment.
She was given two older medications – chlorpromazine and then phenytoin (Dilantin) – which were ineffective. "By 32 weeks, she was very drowsy, had excessive salivation [and] upper limb cogwheel rigidity, and was still hearing voices telling her to kill herself and the ‘alien within’ by slashing her abdomen."
At that point, she ran away from the hospital and into traffic, and was struck by a car. She sustained three broken ribs and a pneumothorax, but the fetus was unharmed. More medication trials followed, and were unsuccessful; she often had to be restrained in bed to prevent her from running away again.
At 36 weeks, she delivered a small-for-gestational-age girl, who was managed in the neonatal intensive care unit for a month. After that, the child’s father was granted full custody, and the patient was admitted to a psychiatric hospital with no contact with her infant.
By the time the baby was 5 weeks old, her mother was again stable, this time on aripiprazole. Although her schizophrenia symptoms remitted, she developed postnatal depression. Without legal access to her child, she eventually broke into the father’s home to see the baby. She failed to attend a compulsory psychiatric consult the next week, and committed suicide 2 days later.
"It’s a horrible story and unfortunately, it’s not one that is familiar to many clinicians," Dr. Kulkarni said. "This is what prompted to me to think about how this situation went wrong. It went wrong because we have no way of knowing what is the safest drug to use for both mother and baby."
[Main story: Neonatal Outcomes Worse in Babies Exposed to Antipsychotic]
She conceived the idea of the registry, which was initially funded "with a tiny grant from the Rotary Club."
Funding now comes mainly from Astra-Zeneca, Janssen-Cilag, and Mayne Pharmaceuticals, as well as the Australian Rotary Health Research Fund.