Ranitidine

[Posted 04/01/2020]

ISSUE: The FDA announced it is requesting manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.

This is the latest step in an ongoing investigation of a contaminant known as N-nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). NDMA is a probable human carcinogen (a substance that could cause cancer). FDA has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.

BACKGROUND: Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.

RECOMMENDATION:

• Consumers: The FDA is also advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved OTC products.
• Patients: Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA. To date, the FDA's testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).
• Consumers and Patients:In light of the current COVID-19 pandemic, the FDA recommends patients and consumers not take their medicines to a drug take-back location but follow the FDA's recommended steps, available at: https://bit.ly/3dOccPG, which include ways to safely dispose of these medications at home.

For more information visit the FDA website at: https://www.fda.gov/Safety/MedWatch/SafetyInformation and https://www.fda.gov/Drugs/DrugSafety.

Ranitidine is used to treat ulcers; gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and injury of the food pipe (esophagus); and conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome. Over-the-counter ranitidine is used to prevent and treat symptoms of heartburn associated with acid indigestion and sour stomach. Ranitidine is in a class of medications called H₂ blockers. It decreases the amount of acid made in the stomach.

Ranitidine comes as a tablet, an effervescent tablet, effervescent granules, and a syrup to take by mouth. It is usually taken once a day at bedtime or two to four times a day. Over-the-counter ranitidine comes as a tablet to take by mouth. It is usually taken once or twice a day. To prevent symptoms, it is taken 30 to 60 minutes before eating or drinking foods that cause heartburn. Follow the directions on your prescription or the package label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ranitidine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Dissolve ranitidine effervescent tablets and granules in a full glass (6 to 8 ounces [180 to 240 milliliters]) of water before drinking.

Do not take over-the-counter ranitidine for longer than 2 weeks unless your doctor tells you to. If symptoms of heartburn, acid indigestion, or sour stomach last longer than 2 weeks, stop taking ranitidine and call your doctor.

Ranitidine is also used sometimes to treat upper gastrointestinal bleeding and to prevent stress ulcers, stomach damage from use of nonsteroidal anti-inflammatory drugs (NSAIDs), and aspiration of stomach acid during anesthesia. Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking ranitidine,

• tell your doctor and pharmacist if you are allergic to ranitidine or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking ranitidine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had porphyria, phenylketonuria, or kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking ranitidine, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Ranitidine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• constipation
• diarrhea
• nausea
• vomiting
• stomach pain

Ranitidine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking ranitidine.

Do not let anyone else take your medicine. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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