There needs to be more government funding into pregnancy and medication research programs, according to Dr. Steve Caritis, one of the leading doctors in this field in the US. The lack of information in this field, he believes, frequently puts women at risk.
“Almost none of the medications used by pregnant women have been studied in pregnancy,” Dr. Caritis told the Pregnancy & Medicine Initiative. “This means that the doses used are commonly improper and may harm the mother if the dose is too high or lead to under-treatment if the dose is too low.”
It is a major problem and one that Caritis has dedicated his work to mitigating. As part of the Obstetric-Fetal Pharmacology Research Units (OPRU) Network, an organization that conducts research into obstetrical pharmacokinetics and pharmacodynamics, Dr. Caritis aims to improve the use of medication during pregnancy.
Funded by the National Institute of Child Health and Human Development (NICHD), the OPRU is currently studying oral hypoglycemics for gestational diabetes, agents thought to alter uterine activity, pravastatin for treatment of preeclampsia, and a broad range of drugs used during pregnancy (including antibiotics and antidepressants).
The effects of the data vacuum
With a career that spans several decades, Dr. Caritis has been able to observe firsthand the effects of the data vacuum around pregnancy and medication. In the US, the average pregnant woman takes seven different medications, yet the effects on her health and her baby’s are largely unknown. “Many of the medications used are not properly dosed,” Dr. Caritis says, and this is because most dosage recommendations are based on non-pregnant women or males.
In 2013, after conducting studies into the morning sickness drug Diclectin, OPRU had an important triumph. Dr. Caritis and his team were able to prove the treatment as safe during pregnancy and determine the appropriate dosage. (Diclectin was since approved by the FDA.)
Much remains to be done and Dr. Caritis feels that pharmaceutical companies should be more willing to step up to the challenge. But he believes the US’ climate of lawsuits and litigation as well as financial restraints is at the heart of the matter, which is why he is calling for more government funding into this area of research.
“The industry doesn’t want to spend the money to study medications due to fears of litigation if pregnancy outcomes are bad, even if the medication had nothing to do with bad outcome,” Dr. Caritis says. “It is shocking that when we need the best pharmacological information to protect mother and baby, we have almost no information – and all this is fixable yet no one except NIH is stepping forward to address the issue. Where is congress?”