WITHDRAWAL OF RANITIDINE
In April 2020, the
Food and Drug Administration (FDA)requested that all forms of prescription and over-the-counter (OTC) ranitidine (Zantac) be removed from the U.S. market. This recommendation was made because unacceptable levels of NDMA, a probable carcinogen (cancer-causing chemical), were found in some ranitidine products. If you’re prescribed ranitidine, talk with your doctor about safe alternative options before stopping the drug. If you’re taking OTC ranitidine, stop taking the drug and talk with your healthcare provider about alternative options. Instead of taking unused ranitidine products to a drug take-back site, dispose of them according to the product’s instructions or by following the FDA’s guidance.
Ranitidine, brand name Zantac, is now marketed as Zantac 360, which contains a different active ingredient (famotidine). Famotidine is in the same class as ranitidine and works the same way but has not been found to contain unacceptable levels of NDMA.
All babies spit up from time to time — especially after a feeding. However, babies who spit up frequently and have other symptoms, such as poor weight gain, irritability, or a prolonged cough, may have gastroesophageal reflux disease (GERD).
In GERD, the contents of the stomach, such as acid and food, are regurgitated back up the esophagus. Sometimes this can cause your infant to vomit. This can lead to poor weight gain and erosion of the esophagus.
GERD occurs in infants for several reasons. However, it’s usually because the lower esophageal sphincter, which closes the esophagus off from the stomach, may not be mature enough to close properly.
Just like GERD in adults, GERD in infants can be managed several ways. Your doctor may first recommend that you make changes in feeding, such as:
- adding rice milk or cereal to your infant’s bottle
- burping your infant after they have consumed one to two ounces of breast milk or formula
- avoiding overfeeding
- holding your infant upright for 30 minutes after a feeding
If changes in feeding don’t seem to help your baby, your doctor may recommend medications.
There are several types of medications that may help relieve GERD symptoms.
Gastric acid-buffering agents, or antacids, help neutralize acid from the stomach. Some examples include Rolaids and Alka-Seltzer. Though they help relieve symptoms, antacids aren’t recommended for long-term use because they can cause complications and side effects, such as diarrhea and constipation.
Check the labels of all over-the-counter medications before you give them to your child. Most over-the-counter antacids aren’t approved for children under the age of two.
Mucosal surface barriers
Mucosal surface barriers or foaming agents help protect the surface of the esophagus from stomach acid. One example is Gaviscon, which is approved for infants over one year old. The main side effects of this medication are constipation and diarrhea.
Gastric antisecretory agents
Gastric antisecretory agents help reduce the amount of acid the stomach produces and are the GERD medications most commonly prescribed for infants. There are two kinds of antisecretory agents that help reduce the acid in the stomach. These are histamine H2 receptor antagonists (H2RAs, or H2 blockers) and proton pump inhibitors (PPIs).
Some common H2RAs are:
- cimetidine (Tagamet)
- famotidine (Pepcid)
- nizatidine (Axid)
These medications start working quickly. However, they aren’t usually recommended for long-term use in infants.
PPIs are another class of drugs that reduce the amount of acid in the stomach. Some common PPIs are:
- esomeprazole (Nexium)
- omeprazole (Prilosec)
- lansoprazole (Prevacid)
- rabeprazole (AcipHex)
- pantoprazole (Protonix)
PPIs are generally more effective than H2RAs and are better for healing the esophagus from gastric secretions. Experts recommend using the smallest possible daily dose for infants.
PPIs aren’t officially approved for general use in infants under one year old. However, esomeprazole has recently been approved for use in infants over one month old for certain conditions.
Your child’s doctor may consider prescribing these medications if they believe the benefits outweigh the risks.
Both H2RAs and PPIs reduce the amount of acid in the stomach. Therefore, infants who take these medications are at increased risk for pneumonia and gastrointestinal tract (GI) infections. This is because stomach acid can help to protect from infection.
Prolonged use of PPIs can make it difficult for the body to absorb calcium. PPIs have been connected with an increased risk for bone fractures in adults. However, there hasn’t been research done to examine a link between bone fractures and infants.
Work closely with your doctor to understand the benefits and risks of any medication prescribed for your infant.