June 11, 2009

Metoclopramide for Hyperemesis Gravidarum

Hyperemesis gravidarum is a fancy way of saying really really bad "morning sickness," severe nausea and vomiting associated with pregnancy.

There have not a lot of drug options here in the U.S., ever since thalidomide was shown to cause severe birth defects - phocomelia, where the children have shortened "flipper" like limbs. As you might imagine, pregnant women are very hesitant to participate in drug trials. It is just as hard to get children enrolled in studies. Unfortunately, the fundamental goal of trying to protect infants and children gets warped from lack of knowledge... and we know very little about how to medicate lil kiddos!

NYT Health says that Metoclopramide is safe for pregnancy. Reglan, as it is more commonly known, is a common anti-nausea medication has been shown to be safe in over 80,000 births in southern Israel.
Our study [The Safety of Metoclopramide Use in the First Trimester of Pregnancy] is about 10 times larger than all of the other studies of this drug put together,” said Dr. Rafael Gorodischer, one of the study’s authors and a professor emeritus of pediatrics at Ben-Gurion University in Israel. “We studied exposure in the first trimester because that is the most critical period for the development of the fetus, when most malformations would be caused by an external cause.”

“We can now say with a high degree of confidence that it’s a safe medication,” he said.

On the heels of this announcement, the British Medical Journal published their ClinicalEvidence on Nausea and Vomiting in Early Pregnancy (updated June 3rd 2009.)
Metoclopramide for treating hyperemesis gravidarum: One RCT found that metoclopramide was less effective at reducing vomiting episodes and readmission to the intensive care unit compared with corticosteroids. Other drugs and interventions may be more useful. Categorised as Unlikely to be beneficial.
Hm... so what does this mean? There is proven safety, but no clinical efficacy in severe cases. Clinical trials will need to be performed to look at this further. And thanks to this new study, we can! :)

1 comment:

  1. I realize how old of a post this is but wanted to comment... I was just searching for this kind of information and it makes me sad to know that so many women could be miserable without need because the BMJ said Reglan's efficacy was low. I have been tried on multiple different medications for hyperemesis gravidarum and it was not until adding in the Reglan I found mych relief at all! It was that way with both my pregnancies. I think the benefits far outweigh the risk when you lose over 7% of your bodyweight in 6 weeks time! Thank for posting! Put my mind at ease to hear about the study in Israel.