Is ranitidine safe to use during pregnancy?

It is important for pregnant mothers and women to minimise the use of pharmaceutical medicines, as even over-the-counter medicines may have detrimental effects on the foetus during pregnancy. There are some medicines that are safe, while some are not. 

What is Ranitidine?

Ranitidine, also known as Zantac®, works to reduce the amount of acid produced by the human stomach and can also be taken to treat and prevent stomach ulcers. It usually comes in the form of soluble tablets that dissolve in water and in liquid form, for direct consumption. 

Ranitidine is commonly used to treat indigestion, heartburn and acid reflux, which is common among pregnant women. It can also be used to treat gastro-oesophageal reflux disease (GORD), a digestive disorder that occurs when acid reflux constantly occurs, where your stomach acid, food or fluids, go upwards to the oesophagus, from the stomach. 

Ranitidine is also occasionally prescribed to treat the Zollinger-Ellison syndrome – a rare disease caused by a tumour in the pancreas or gut. 

What Research Says

According to the United States Food and Drugs Administration (FDA), and Australia’s Therapeutic Goods Administration (TGA), Ranitidine is placed under pregnancy categories B and B1. According to the FDA, drugs under category B demonstrate that studies done on animals did not show any risk to foetus, but there are no adequate and well-controlled studies done on pregnant women to confirm the lack of risk to the human foetus. This is supported by TGA, whereby drugs under category B1 are drugs that have studies done only on a limited number of pregnant women, as well as women of childbearing age, without an increased frequency of deformation or observed detrimental effects on the human foetus. 

Research on the safety of ranitidine (Zantac®) on pregnant women derived that pregnant women who took ranitidine throughout the pregnancy period, since the first trimester, have delivered healthy babies. Medical research done on animals also did not provide conclusive evidence of impaired fertility or harmful effects on the foetus. However, this data is not sufficient to determine if ranitidine is safe to be consumed during pregnancy, as well as its effects on the child’s long-term health. 

Also, note that the FDA recently announced that manufacturers who produce prescription and over-the-counter ranitidine drugs are to be withdrawn immediately from the market. This is due to an ongoing investigation on N-Nitrosodimethylamine (NDMA), a contaminant that is found in ranitidine medicines (Zantac®). The FDA has concluded that the impurities of some of the ranitidine medicines which increase over time, when it is stored at a temperature higher than room temperature, may expose consumers to unacceptable levels of it. With that being said, it is better to check with your doctor or pharmacist before taking ranitidine, to prevent unwanted complications that might affect the well-being of both the mother and the baby. In the cause[1]  that you may need medication to counter any problems you may be experiencing, they may have a better solution. 

All Ranitidine tablet has been called back by KKM. It is not used anymore due to excess substance known as NMDA – which is carcinogenic (can cause cancer). Currently, the only ranitidine available is in injection form which is not available over the counter. There are other options that are used to treat gastroesophageal reflux disease like omeprazole (proton pump inhibitor). [1]

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