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What Are the Concerns about Ranitidine and Breastfeeding?

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  • Written By: Jillian O Keeffe
  • Edited By: Shereen Skola
  • Last Modified Date: 23 November 2016
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Ranitidine is a drug that is often recommended for those suffering from stomach problems like heartburn. As of 2011, reported side effects have been rare, but the potential effects on newborn or very young children have not been extensively researched. Ranitidine and breastfeeding mothers may not be a suitable mix, especially as the drug is known to pass into the breast milk. Advice to avoid its use during breastfeeding is not based on concrete evidence of harm to the baby, but rather on the basis that the drug may have effects that have not yet been identified.

Infants are fragile creatures as they are still developing, and are so more vulnerable than other people to the effects of drugs. Medications in pregnancy tend to be closely monitored, and breastfeeding mothers may be discouraged from taking certain drugs. If a baby is breastfeeding, the mother can pass substances to him or her through breast-milk, and potentially put the child at risk. When it comes to ranitidine and breastfeeding, ranitidine has been proven to enter the breast-milk, which is why its use may be risky for the mother and child.

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Clinical studies of drugs normally focus on the effects of the medication on adult volunteers. Children, pregnant women, and babies are not typically used for research for ethical reasons. For many medications, therefore, the evidence for safety in pregnancy or during breastfeeding tends to be incomplete. Sometimes extensive information on the possible effects of medicine can be gleaned from individual patients who are taking the drug outside of clinical trials, but this is not the case for investigation into ranitidine and breastfeeding.

Isolated incidences of ranitidine and breastfeeding have been noted in medical literature, and these cases appear to show that ranitidine does not have any adverse effect on the breastfeeding infant. Studies on animals have also not shown that the drug has any adverse effects in fetuses during pregnancy. Some women receive the drug during labor to prevent a condition called Mendelsohn's syndrome, and the drug appears to produce no adverse effect on the baby.

A condition called stress ulcer can develop in some babies, and ranitidine is often used to prevent this from developing. When given to newborn babies, at a level five times higher than that typically found in breast-milk, the drug appears to have no ill effects. As of 2011, a drug called cimetidine, which is similar to ranitidine, is approved by some health authorities for use by breastfeeding women. Despite the availaility of a small amount of information appearing to show that ranitidine is safe for use in this situation, the lack of research means that women have to balance the benefits of the drug against the theoretical possibility of damage to the baby.

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