As Dr. Emily Senay explains: "The reasons for this more recent data showing that women who take this medication during the first trimester have an increased risk of having babies who have certain heart malformations. They also recommend women who have taken it during the early part of pregnancy should consider having a fetal ultrasound or fetal echocardiogram, looking at the baby's heart to make sure they don't have this problem."
"Now, having said this, I certainly don't want to panic people or make women overly concerned. Fortunately, these types of problems in babies are rare. So this is caution on their part," Senay adds.
How long has this information been known for?
"It's interesting. About a year ago, the maker of Paxil and the FDA changed the labeling of the product and actually increased it from a 'Category C,' which means that there was evidence of potential problems in animal studies, to a 'Category D,' which means that there was now some new data from studies done abroad and here showing that it had harm in humans," Senay says. "It's been known for quite a while. But now this information is based on that data. This is a way to guide doctors and patients to how to incorporate this information in the practice."
What if you are a woman who is pregnant or trying to get pregnant and you are not on a different antidepressant?
Paxil falls under a class of commonly used drugs called SSRIs — selective serotonin reuptake inhibitors; Besides Paxil, other brands of SSRIs include Prozac, Zoloft and Lexapro.
"Women on these other medications, besides Paxil, should weigh the risks and benefits. Although there is not data that they contain the same harm that Paxil might," Senay points out. "So really this is a call to individualize the treatment to the woman because depression in and of itself is a serious problem during pregnancy or at any time. So they want to make sure women are treated correctly and these medications are used appropriately. But right now Paxil is the one they singled out."
Doctors don't want women to abruptly stop taking Paxil or similar medications.
"They have found that about two-thirds of the women who abruptly stop medications during pregnancy, will relapse into depression, compared to a quarter or less who relapse when not on anti-depressants," Senay warns. "So this is really a call for women to plan their pregnancy and work with their doctor, obstetrician and psychiatrist to make sure they have the best treatment possible."