Over the last few months, I received many questions regarding the ranitidine (Zantac) recall. Women with morning sickness and/or hyperemesis gravidarum often take ranitidine to decrease their amount of stomach acid, allowing them to feel better throughout the day. This medication does not require a prescription, which means it has met a standard of safety by the FDA to be over-the-counter (OTC). Since it’s proven to have a high safety rating, it is interesting to look at why it was recalled as well as possible alternatives.
What is ranitidine (Zantac) and how does it work?
Zantac is the brand name of a stomach medicine that has the active ingredient ranitidine. The Food and Drug Administration (FDA) has approved the OTC strength to prevent and relieve heartburn associated with acid ingestion and sour stomach, while the prescription strengths are approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease (GERD). It works by blocking histamine receptors on special cells in the stomach called parietal cells, which are the cells that release acid. Once the medicine is active in the stomach, the acid is blocked. With less acid in the stomach, there will be less nausea and reflux. Ranitidine is part of a class of medications called Histamine 2 Receptor Antagonists (H2RAs) which are also called H2 blockers. Other medications in the same class, meaning they work the same way and can be taken to achieve similar effects, include:
- famotidine (Pepcid)
- cimetidine (Tagamet)
- nizatidine (Axis). *In January 2020, nizatidine was recalled for the same reason as ranitidine last fall.
Why is ranitidine (Zantac) recalled?
Valisure, an independent pharmacy in Connecticut, opened up when a couple of friends discovered that their medications were not meeting the standards set by the FDA to be distributed in the United States. With the FDA overseeing the safety of medications approved for Americans, we take it for granted that medications satisfy the requirements, but since most medications are not manufactured in the United States, there is no way to ensure every medication is to specifications. Valisure surprisingly found unacceptable levels of NDMA in ranitidine and alerted the FDA. NMDA is listed by the EPA as a carcinogen, a cancer causing agent. At the moment, this is an unusual way for a medication to be recalled. In fact, manufacturers are asking if the testing method itself could have caused the N-nitrosodimethylamine (NMDA) to form as the medication breaks down in the body. The testing was done with heat, which does not mimic exactly how the medication breaks down in the body. For more information on NMDA, take a look at this article in Scientific American.
Another class of medications that work on stomach acid are called proton pump inhibitors (PPIs). These include:
- deslansoprazole (Dexilant)
- esomeprazole (Nexium)
- lansoprazole (Prevacid)
- omeprazole (Prilosec)
- pantoprazole (Protonix)
- rabeprazole (Acidphex).
PPIs work on the proton pump to prevent acid, which are hydrogen ions, from getting into the stomach. Both H2RAs and PPIs are considered safe in pregnancy, but ranitidine is the most studied, which is why it is recommended first.
What are ranitidine (Zantac) alternatives?
ALWAYS check with your doctors before making any changes!
What options do pregnant women with acid reflux, morning sickness and/or hyperemesis gravidarum have?
- Switch to another medication in the same class, famotidine (Pepcid) for example.
- Try a PPI, such as omeprazole (Prilosec). Keep in mind that PPIs are dangerous for long term use, so always take the least amount needed. There are many important reasons that our stomachs make acid and we don’t want to suppress the acid over the long term. Long term use, considered more than one year, is being linked to increased risk of alzheimers, bone loss and some infections.
- If you haven’t already tried acid suppressors that have calcium, then ask your doctor if you can try Tums or Rolaids. My clinical sources have contradicting information regarding antacids with magnesium, including Maalox. Some say they are safe at low doses, some say to avoid during the third trimester and others have either C or D pregnancy ratings, so I would recommend getting your doctors approval before trying any that have magnesium as an ingredient.
How do you know if your medication has been recalled?
How do you know if the medication you are taking has been recalled? Go to the US Food and Drug Administration (FDA) website: You can also call your manufacturer. The tricky part is that often times, not all lot numbers, the batch involved, have been recalled, so check to see if the pharmacy that dispensed your medication kept track of which lot you received. Unfortunately, the company I used to work for did not keep track of this. In the case of ranitine, at this point, just about all manufactures have recalled all lot numbers.
Pharmacists get lists of recalled medications daily. While some of these medications are recalled due to serious issues, the majority, fortunately, are not. Recalled medications are categorized as class I, II or III. According to the FDA, a class I recall is the most urgent type, class II is temporary or medically reversible and a class III recall is unlikely to cause any adverse health effects. An example of a class I recall happened when tablets for a heart medicine called hyoscamine was found to have different strengths ranging from weak to superpotent. A class II recall example happened when the measuring cup, that it included with the medicine Children’s Advil, was marked incorrectly. A class III recall happened when Fentanyl patches were leaking. Ranitine was not actually recalled by the FDA but was a voluntary recall by individual drug manufacturers.
More often recalls happen from reports to the manufacture and/or the FDA by consumers, pharmacists, doctors and other medical professionals. If you’re not familiar with how to report an adverse reaction to a medication, go to the FDA’s Medwatch site:
If you have questions about the safety of your medication, you have many places to find answers:
- Your pharmacist: Every pharmacy has a pharmacist available to answer medication questions. This includes a retail pharmacy, a mail order pharmacy, outpatient hospital pharmacies and even insurance company pharmacies
- The doctor who prescribed the medication
- The FDA Recall Site
- The FDA MedWatch
- The manufacturer: As bad a reputation as pharmaceutical manufacturers have, they are always happy to answer questions about safety. A quick google search should have their phone number. Most of the manufacturers can be reached in the US during eastern standard time.
Of course, I am always ready to support you in your search for information and answers to help ease your HG, and if I cannot, then I will put you in touch with someone who can. If there is anything more you’d like to learn about ranitidine or recalled medications or have news to share with me, email info@hgpharmacist.com.
