Safety of Nausea Drug Reglan During Pregnancy Confirmed

Reglan Safety During Pregnancy

About half of pregnant women will experience nausea and vomiting during the early months of their pregnancies.  While most women can manage their morning sickness without taking any sort of medication, about 10 to 15 percent of them will need something further.  Antihistamines or vitamin B6 may work for some of these women; however, if they do not, it may be necessary to take a prescription nausea drug like Reglan (metoclopramide) to control these symptoms.  But, what do we know about this drug’s safety for the developing fetus?

Reglan currently falls under the U.S. Food and Drug Administration’s category B.  This means that it has not caused any harm to unborn young in animal studies; but, it has yet to be proven safe in human studies.

In order to demonstrate whether it is indeed safe for humans during pregnancy, Bjorn Pasternak and his colleagues at the Statens Serum Institut in Copenhagen, Denmark studied 1,222,5o3 pregnancies in Denmark between the years 1997 and 2011, comparing how women’s pregnancies fared when they used the drug compared to when they did not.

Out of this group, they studied 28,486 infants who had been exposed to the drug versus 113,698 who were not.  Of these, there were 721 exposed babies and 3,024 unexposed babies who were diagnosed with a major malformation during their first year after birth.  This translates to 25.3 per 1,000 births for exposed babies and 26.6 per  1,000 births for unexposed babies.  So, statistically speaking, there was no real difference between the two groups.

When they examined individual types of birth defects – such as cleft palate, neural tube defects, and limb abnormalities – they found no link between the mother’s use of the drug during the first trimester of pregnancy and these conditions.  The researchers examined altogether 20 different types of malformations.

The researchers also did not find any links between Reglan use and miscarriage, stillbirth, prematurity, low birth weight or growth restriction during pregnancy.

The authors say they hope that this confirmation of Reglan’s safety during pregnancy will help inform doctors and their patients when they make the choice of how to handle severe morning sickness symptoms.

For women with less severe morning sickness, doctors generally recommend such steps as eating smaller meals throughout the day so that the stomach is never empty, keeping crackers and other simple foods by the bed to nibble on before getting out of bed and avoiding very hot foods, which tend to give off stronger odors than colder foods.  They also recommend that women avoid fatty, spicy or acidic foods, which tend to create more stomach upset.

Another common recommendation is for women to drink plenty of fluids in order to prevent dehydration.

If women find that they are vomiting constantly, cannot keep liquids down, feel dizzy upon standing or have dark or infrequent urination, doctors recommend that they seek medical help since they may be becoming dehydrated.  This is a condition which is known in medical terminology as hyperemesis gravidarum.

For women who do need to seek medical help, however, it may be comforting news to learn that nausea-fighting drugs like Reglan do appear to be safe for human consumption during pregnancy.

The study was published in the October 16, 2013 issue of JAMA.

Written by:  Nancy Schimelpfening

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