Zantac And Other Heartburn Drugs Recalled Over Possible Cancer Link
Washington U.S. health regulators are telling drugmakers to immediately pull their popular heartburn drugs off the market after determining that a contamination issue with the medications poses a greater risk than previously thought.
The move from the Food and Drug Administration Wednesday applies to all prescription and over-the-counter versions of ranitidine, best known by the brand name Zantac. The drugs are widely used to treat stomach acid and ulcers.
Patients should stop taking any of the medications they currently have and throw them away, the FDA said.
The agency last year said patients could continue taking the medications and did not face health risks from low levels of a “probable” cancer-causing contaminant found in multiple brands.
But officials reversed that decision, saying they’ve now determined that levels of the chemical increase over time, especially if tablets and capsules are stored at higher temperatures. That poses an unacceptable risk to patients, they said.
“Since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients,” said Dr. Janet Woodcock in a statement.
Woodcock said there are multiple alternative medications to treat heartburn, including Prilosec, Nexium and Tagament.
The FDA has suspended nearly all U.S. and foreign inspections due to travel restrictions caused by the coronavirus outbreak.
What Other Drugs Could Interact With This Medication
There may be an interaction between ranitidine and any of the following:
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter , and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 2021. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Zantac
Rated For Barrett’s Esophagus Report
Fewer side effects than Proton Pump Inhibitors Ranitidine is a H2 blocker with the medical proffesion these have gone out of fashion since the new and more expensive Proton Pump Inhibitors came on the scene. I have Barrett’s Esophagus caused by acid reflux. For me proton pump inhibitors don’t cut it because of side effects, they cause dry eyes, flare ups of my colitis and worst of all erectile dysfunction. My wife also takes a Proton Pump Inhibitor and suffers from dry eyes and vision blurring but Ranitidine just dosen’t work for her. On changing to Zantac Initially I was precribed 150mg Zantac twice per day but found it only stopped acid production for 8 to 10 hours leaving a 2 to 4 hour gaps when heartburn became a problem. I persuaded my doctor to try putting me on 75mg three times per day and this worked. More recently I have tried cider apple vinegar therapy once a day to reduce acid production to my great surprise it works and I am now back down to 75mg Zantac twice per day. Strangely Cider Apple Vinegar and also Red Grapefruit Juice appear to aid healing of uclers and acid burn damage.
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The Zantac Recall And What You Can Do About Gerd
Zantac is a common antacid which has been in use for years. It belongs to the same class at Pepcid, Tagamet, and Axid. It is a different class of drug as Prilosec, Protonix, Dexilent, and Nexium. Zantac has IV and oral forms. It has been used for the treatment of GERD/heartburn, ulcers, gastritis.
The Food and Drug Administration recently revealed that Zantac contains low levels of a cancer-causing contaminant known as N-Nitrosodimethylamine . NDMA was previously identified in a blood pressure drug, leading to recalls. NDMA is associated with increased risk of cancers of the liver, stomach, bladder, kidney, and other organs. The risk is likely higher with prolonged exposure to NDMA. The agency determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures.
We didnt observe unacceptable levels of NDMA in many of the samples that we tested. However, since we dont know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured, said Janet Woodcock, M.D., director of the FDAs Center for Drug Evaluation and Research.
This Popular Heartburn Medication Has Been Pulled From Shelves What Are Some Zantac Alternatives
If you have been taking Zantac, an over-the-counter acid reducer and heartburn medication, you may have heard that the drug is being pulled off many retailers’ shelves. That’s because the Food and Drug Administration recently expressed concern that some forms of the medication both name brand and the generic form, ranitidine may contain a potentially cancer-causing ingredient, N-nitrosodimethylamine .
This ingredient, classified as a probable human carcinogen, was previously connected to recalls of some prescription blood pressure and heart failure medications. Zantac and ranitidine contain unacceptable levels of NDMA. Although levels may be barely more than what is found in water and some foods, more investigation is needed to determine if the amount of NDMA in ranitidine poses a risk to people taking the medication. While this is being done, drug manufacturers have voluntarily recalled medications and major chains like CVS, Rite Aid, Walgreens and Walmart have stopped selling them.
So what do you do now if you’ve been taking Zantac or a similar medication for your heartburn or acid reflux?
Talk to your doctor about alternative medications. In the meantime, try these natural heartburn remedies. They may help relieve symptoms without medication:
Editorial Review: Andrea Cohen, Editorial Director, Baldwin Publishing, Inc.
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What If My Heartburn Won’t Go Away
Occasional heartburn is common, especially after big meals, and usually is not serious. But sometimes, that burning sensation can indicate something more serious, such as ulcers, bleeding or an inflammation of the lining of the esophagus.
Gastroenterologists recommend contacting your doctor’s office if your heartburn won’t go away after two weeks, you’re having trouble swallowing, or your heartburn is causing nausea and vomiting.
What Do My Employees Need To Know
Now that there is one less treatment option available for heartburn, acid reflux, GERD, and peptic ulcer disease, inform your employees about the recall and encourage them to talk to their doctor about alternative medications or treatments. You can also share tips to reduce the chances of experiencing heartburn, which include lifestyle changes like:
- Maintaining a healthy weight
- Avoiding common trigger foods and beverages External Site External Site, like alcohol, garlic, onions, spicy foods, chocolate, citrus fruits, coffee, tea, soda, peppermint and tomatoes
- Wearing loose-fitting clothing
- Allowing two hours after a meal before lying down, and avoiding late-night meals or snacks
- Limiting the use of certain OTC medications, such as NSAIDs, which can damage the protective layer within the stomach with prolonged use
Questions? Contact your authorized Wellmark Blue Cross and Blue Shield account representative, or email us at .
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What Has Been Recalled And Why
Companies that make the antacids ranitidine and nizatidine have voluntarily recalled more than a dozen lots of unexpired medications in 150 mg and 300 mg strengths. Exact lot numbers of the recalled drugs can be found on the FDA’s website.
The FDA said the medicines may contain “unacceptable” amounts of N-Nitrosodimethylamine , a substance the World Health Organization has classified as a “probable human carcinogen.”
Valisure, an online pharmacy that analyzes every batch of medications it receives, first discovered the elevated NDMA levels in samples of ranitidine.
The company’s CEO, David Light, told NBC News that ranitidine is “inherently unstable.” That means that the presence of NDMA in the drug isn’t the result of bad manufacturing practices, but the molecular makeup of ranitidine itself. When exposed to heat, it breaks down and forms NDMA.
How To Use Zantac 360 Original Strength
To treat heartburn and acid indigestion, take 1 tablet or capsule with a glass of water as needed, unless otherwise directed by your doctor. Swallow the tablets and capsules whole without chewing. If you are using the chewable tablets, chew completely and swallow one tablet as needed. Do not swallow whole. Famotidine can be taken with or without food.
Do not take more than 2 tablets in 24 hours unless directed by your doctor. Follow all directions on the product package. If you have any questions, ask your doctor or pharmacist.
Stop taking this medication and call your doctor promptly if your symptoms continue after you begin taking it, or if they do not improve after you have been taking this medication for 14 days in a row. Do not take this medication for more than 14 days in a row without talking with your doctor.
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Ndmas Links To Cancer
The International Agency for Research on Cancer lists NDMA as a probable carcinogen in humans. This means that NDMA has, in testing, been found to cause cancer in rats and other animals and therefore carries the risk of also causing cancer in humans in amounts above a certain quantity.
Exposure to NDMA has been linked to the following types of cancer:
Additionally, but less frequently, NDMA exposure has also been linked to the following cancers:
- Non-Hodgkins Lymphoma
How To Use Zantac Oral
Take this medication by mouth with or without food as directed by your doctor, usually once or twice daily. It may be prescribed 4 times a day for some conditions. If you are taking this medication once daily, it is usually taken after the evening meal or before bedtime.
The dosage and length of treatment are based on your medical condition and response to therapy. In children, dosage may also be based on body weight. Follow your doctor’s instructions carefully. You may take other medications for your condition as recommended by your doctor.
Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time each day. Do not increase your dose or take it more often than prescribed. Do not stop taking this without your doctor’s approval because this may delay healing of the ulcer.
If you are using nonprescription ranitidine for self-treatment of acid indigestion or heartburn, take 1 tablet by mouth with a glass of water as needed. To prevent heartburn, take 1 tablet by mouth with a glass of water 30-60 minutes before eating food or drinking beverages that cause heartburn. Do not take more than 2 tablets in 24 hours unless directed by your doctor. Do not take for more than 14 days in a row without talking with your doctor.
Tell your doctor if your condition does not improve or if it worsens.
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Poison Control Should Be Your First Call If You Overdose
If you ever think that your baby may have been overdosed with any medicine call Poison Control first. Unless your baby is showing signs of physical distress calling Poison Control before heading to the emergency room is a good idea. In the case of ranitidine an overdose is usually not a major health risk, just dont make it a habit. Even in cases where babies have been given 10 times the recommended dose accidentally the baby has been just fine. Poison Control can advise you whether to seek emergency medical help immediately or to monitor your babys condition and will usually save you a time consuming and costly trip to the ER.Poison Control is staffed by experts that can advise you. Poison Controls phone number is 1-800-222-1222 and can be reached 24/7.
Zantac Syrup Is Designed For Children One Month To 14 Years
Your doctor can prescribe a Zantac syrup that is safe for children. Chemically, the syrup that your doctor prescribes is identical to the tablets you can get OTC but it is not possible to get the correct dosage with the tablets. The correct dosage is determined by the weight of the person taking it and because your baby requires a much smaller dosage than an adult the syrup can be given with much more precision and is the only safe way for your baby to take the drug. This syrup is available by prescription only.
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Should You Keep Taking Zantac For Your Heartburn
Versions of the drug have been found to contain low levels of a carcinogen. But its still on pharmacy shelves. Heres what you need to know.
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This article was updated on Sept. 20 to reflect actions taken by other countries.
The heartburn drug Zantac has been on the market for decades, and was considered safe enough to be sold over the counter and regularly given to infants.
But on Sept. 13, the Food and Drug Administration said that it had detected low levels of a cancer-causing chemical in samples of the drug, which is also known as ranitidine. The agency advised patients who were taking over-the-counter versions of Zantac to consider switching to other medications.
On Sept. 18, the drug maker Novartis said that its generic-drug division, Sandoz, had stopped distributing a prescription form of ranitidine worldwide as it investigates the issue. Another major generic manufacturer, Dr. Reddys Laboratories, also said it was halting distribution.
The companies, including Sanofi, which manufactures the brand-name version, have stopped short of recalling their products in the United States.
Pepcid Vs Zantac Product Comparison Chart
PEPCID® was authorized for sale by Health Canada in 1996 for treatment andprevention ofheartburn. It has been available over-the-counter in 10 mg and 20 mg strengths since 1996 and2007,respectively.
PEPCID® AND ZANTAC® are approved for the same use. However, PEPCID® contains Famotidine. UnlikeZantac® andother OTC products that contain Ranitidine.
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Prevent Or Relieve Heartburn With Zantac 360 Otc
For a flexible, all-in-one heartburn solution, newZantac 360° over-the-counter heartburn medication has a new formula with the #1 doctor recommended medicine approved to both prevent and relieve heartburn*:
Learn more about newZantac 360°.
*Among OTC H2 Blockers.
Refers to acid control. Acid control does not correlate to symptom relief.
What Is Ranitidine And Which Products Are Affected
Ranitidine is available both over the counter and by prescription. It belongs to the class of drugs known as H2 blockers. OTC ranitidine is commonly used to relieve and prevent heartburn. Prescription strengths are also used to treat and prevent more serious ulcers in the stomach and intestines. Multiple companies sell generic versions of both the OTC and prescription products.
So far, only Novartis/Sandoz and Apotex have recalled products. Ranitidine distributed by other companies remains on store shelves.
Health Canada, a federal department within the Canadian government, has asked all companies to stop distributing ranitidine drugs there, indicating that “current evidence suggests that NDMA may be present in ranitidine, regardless of the manufacturer.” France has taken the step of recalling all ranitidine products.
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Rated For Interstitial Cystitis Report
ranitidine This is excellent. 150mg twice a day, or 300mg at night. Have used off and on for years. Highly reccomend trying it, I cant think of another remedy with fewer side effects, ease of use, or more cost effective. This IS available OTC in 150 and 75mg strengths, the box says 75-150mg but thats for heartburn, it is extremely safe to take 300mg/day or even more. start with 150mg X 2 or 300mg at night.
Are Prilosec And Zantac 360 Safe To Use While Pregnant Or Breastfeeding
Omeprazole is excreted in breast milk and potentially could cause adverse effects in the infant.
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Thats Except When I Failed Scott
What do I mean by failing Scott?
You know what happens when we get a good thing going. We too quickly forget the hard times.
And, little by little, I began to forget taking the remedy.
I would run out of the ingredients or forget to take it with me when traveling.
Or, most idiotic of it all: Sometimes, I thought I didnt have five minutes to spare to make it.
Imagine having a remedy that you know would eliminate your acid reflux every time, and you just decide in your mind that its not worth five minutes to make it.
Well, my brain is obviously not the brightest.
And that was okay for a few days
until one night, when the reflux assaulted me with full force again.
As luck would have it it was exactly a night spent in a hotel, where I had none of the ingredients needed.
Worst night of my life!
Most of it was spent with my head in the toilet.