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Which Heartburn Medication Was Recalled

What Is Zantac Used For

Heartburn Medication Recall Expanded

Zantac both the original and the new version is often used to treat or prevent heartburn and acid reflux. At higher, prescription-only doses, it can also be used to treat stomach ulcers and erosive esophagitis . When prescribed by a healthcare provider, Zantac can be used in people of all ages, even newborn infants.

Unlike proton pump inhibitors, such as and , which can take several days to kick in and lessen symptoms, Zantac starts relieving heartburn 15 to 60 minutes after you take it. And it will keep working for up to 12 hours, compared to traditional antacids like Tums and Mylanta that tend to wear off within a half-hour.

These qualities make Zantac a great choice for people who have occasional heartburn or know theyre likely to experience it soon.

Fda Advises Consumers Patients And Health Care Professionals After New Fda Studies Show Risk To Public Health

The U.S. Food and Drug Administration today announced it is requesting manufacturers withdraw all prescription and over-the-counter ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine in ranitidine medications . The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and 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.

The FDA is committed to ensuring that the medicines Americans take are safe and effective. We make every effort to investigate potential health risks and provide our recommendations to the public based on the best available science. 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. The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.

How Is Zantac 360 Different From The Original Zantac

Both Zantac 360 and original Zantac included H2 blockers. The previous version contained a medication called ranitidine. Just like famotidine, it worked within an hour and lasted for up to 12 hours. Prior to the 2020 recall, many people had a personal favorite they preferred, but in studies both famotidine and ranitidine were equally effective for heartburn and acid reflux.

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Fda Requests Zantac Be Pulled From The Market

April 1, 2020 — Six months after independent testing first raised the possibility that popular heartburn drug ranitidine might break down into the powerful carcinogen n-nitrosodimethylamine , the FDA has asked for the removal of all ranitidine products from the market. If youâre taking it now, stop.

âThe agency has determined that the impurity in some ranitidine products increases over time when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity,â the FDA said in the announcement.

The agency doesnât have mandatory recall authority, which is why this is only a request, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a media briefing. But given the safety issues, they anticipate full cooperation.

For those who rely on ranitidine to treat their heartburn, the agency suggests several alternatives. âTo date, the FDAâs testing has not found NDMA in famotidine , cimetidine , esomeprazole , lansoprazole or omeprazole ,â the announcement said.

What Is The Recall About

Heartburn Medication Recall Nexium ~ Share Info Health

NDMA is classified as a probable human carcinogen on the basis of animal studies. It is present in some foods and in water supplies but is not expected to cause harm when ingested in very low levels.

The MHRA has asked manufacturers to quarantine all products which may contain the active pharmaceutical ingredient that is potentially affected by this issue.

The four in the recall are made by GlaxoSmithKline .

Over-the-counter products and Zantac 75 Tablets , which people can buy in pharmacies without a prescription, are produced by a different company and are not affected by the recall.

The MHRA is investigating other ranitidine medicines which may also be affected and will provide updates soon.

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Another Heartburn Medication Recall Due To Ndma Concerns

Following on the heels of massive Zantac and other heartburn medication recalls, yet another medication is being recalled due to concerns about NDMA . The U.S. Food and Drug Administration announced a recall of certain lots of Amneal Pharmaceuticals, LLC Nizatidine Oral Solution. Here is what we know about this latest heartburn medication recall.

Are There Any Other Available Medications That Work Similarly

Yes, the following prescription medications are in the same class of drugs as famotidine. You may be able to use them as alternatives to Pepcid.

    If you take OTC famotidine , there are also alternatives available to you that work in the same way:

    Always consult with your healthcare provider before switching medications to avoid any potentially dangerous drug interactions.

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    What Are The Side Effects Of Zantac 360

    Zantac 360 is very well-tolerated, and most people have no side effects after taking a dose. In clinical studies of famotidine, less than 1% of the participants reported headache, dizziness, or constipation. If youre experiencing anything unusual after starting this medication, contact your healthcare provider to discuss alternatives.

    How Does A Drug Recall Work

    Popular Heartburn Medication Zantac Recalled

    A recall is initiated when a medication is found to be defective, potentially harmful, or both. In the case of Zantac, the FDA issued a market withdrawal request in response to scientists discovering exceedingly high levels of NDMA in ranitidine medications.

    Drug manufacturers or the FDA can issue recalls. If a drug company discovers a potential health hazard, manufacturing issue, or defect, it can issue a voluntary recall. If the FDA receives requests for a recall after the public discovers safety problems with a medication, the agency can issue a recall or the removal of the medication from the market

    The FDAs role in a drug recall involves classifying the severity of the products danger so the public can understand why the recall is happening. The three classifications of recalls include the following:

    • Class I: A dangerous or defective product that could cause serious health problems or death.
    • Class II: A product that might cause a temporary health problem or pose a slight threat of a serious nature.
    • Class III: A product that is unlikely to cause any adverse health reaction but violates FDA labeling or manufacturing laws.

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    Wasnt There Another Acid Reflux Medication Recall Recently

    Yep, thatâs right. In case you didnât already know, late last year ranitidine and nizatidine were recalled by the FDA. Nizatidine is another H2 blocker that treats cases of acid reflux. And like ranitidine, the heartburn medication was recalled due to the presence of NDMA. While the amount of NDMA in these medications is small, high exposure after a long period of time may be dangerous, so the FDA isnât taking any chances.

    How Much Does Zantac 360 Cost

    Depending on the strength and how large of a package youre buying, Zantac 360 can cost between $8 and $30. Be sure to look for generic versions of famotidine, as they are equally effective and will help save you money. Theres also a coupon available on Zantac 360s website that you can print out and use when purchasing the medication in stores.

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    What Is Zantac 360

    Zantac 360 is an oral tablet containing the ingredient famotidine. It comes in two different strengths and is available without a prescription. The over-the-counter tablets are only recommended for adults and children over 12 years old.

    If the word famotidine looks familiar, thats because it is also the active ingredient in brand name Pepcid AC, another over-the-counter heartburn remedy. The famotidine in these competing products is the same. Both provide the same symptom relief, and neither has any advantages over the other.

    Does Zantac 360 Have This Cancer Risk

    Heartburn drug Zantac recalled over cancer fears

    Thankfully, Zantac 360 does not carry this potential cancer risk. After discovering NDMA in ranitidine, the FDA requested other H2 blockers be tested for the carcinogen. They found famotidine had no NDMA in it at all. Because it is free of this chemical, there is no current concern of a possible link to cancer.

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    More Medications Recalled Due To Possible Cancer

    Even more medications are being recalled because they might contain a cancer-causing impurity.

    In late September, the US Food and Drug Administration issued a statement about low levels of a possible cancer-causing impurity found in some ranitidine products. The recall has continued to expand over the last few months.

    The possible cancer-causing impurity the FDA found in ranitidine products is called N-nitrosodimethylamine . These medications may be found under the brand name Zantac. These drugs are available over the counter and via prescription.

    These medications work to prevent heartburn and provide relief tied to acid ingestion by reducing the amount of acid the stomach makes. The prescription version is used to treat and prevent ulcers of the stomach it also treats gastroesophageal reflux disease .

    This recall was recently expanded to include the following prescription products:

    • Appco Pharma LLC is recalling all quantities and lots of ranitidine hydrochloride capsules .
    • Northwind Pharmaceuticals is recalling all unexpired lots of ranitidine tablets .

    The FDA has instructed companies to issue a recall if tests of their ranitidine products show levels of NDMA above the acceptable daily intake. Refer to the details and recall instructions provided by the companies. These details can be found on the FDA’s website.

    Speak with your local pharmacist to determine whether your medication is included in any of these recent recalls.

    Us Food And Drug Administration And Ndma

    In September 2019, the Food and Drug Administration announced preliminary laboratory test results involving ranitidine containing possible contamination of NDMA, a possible human carcinogen.

    Testing ranitidine found unacceptably high levels of N-nitrosodimethylamine , a member of N-nitrosamines. The toxic substance has been found to produce cancer in laboratory animals.

    After the results were released, the FDA did not require discontinuing the product. However, the agency did recommend patients talk with their doctors about using alternative treatments and options.

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    What Is The Difference Between A Market Withdrawal And A Recall

    Here is the difference between a market withdrawal and a recall:

    A is initiated when FDA finds a minor violation that would not be subject to legal action by the agency.

    A recall is initiated when FDA considers a marketed product to be in violation of the laws it administers and subject to legal action .

    The FDA decided it did not have enough information to issue a recall thus, prompting a market withdrawal. Based on the unacceptable levels of NDMA in ranitidine medications as reported in the Valisure and Emery Pharma Citizen Petitions to the FDA, we find it concerning that the FDA didnt actually issue a recall. Rather, the FDA requested that all manufacturers withdraw their Zantac and ranitidine products off the market.

    In the end, it was the drug manufacturers that recalled their own Zantac and ranitidine products.

    Heartburn Medication Recall : More Acid Reflux Medications Recalled Over Cancer Concerns

    Heartburn capsules recalled due to high levels of cancer-causing substance

    After a string of heartburn medications were recalled over the last few months at the urgency of the Food & Drug Administration , Amneal Pharmaceuticals, LLC has recalled three lots of it Nizatidine Oral Solution, a heartburn and ulcer medicine, because it may cause cancer.

    The affected Nizatidine Oral Solution was recalled because it may contain N-Nitrosodimethylamine in levels that exceed the acceptable limits set by the FDA. NDMA is classified as a probable human carcinogen that could cause cancer.

    The recall affects 15mg/mL Nizatidine Oral Solutions packaged in 480 mL bottles. The NDC number for the recalled medication is 60846-301-15 with lot numbers that include 06598004A, 06599001A, and 06599002A. Expiration dates are 04/2020, 12/2020, and 12/2020, respectively.

    The affected medication was distributed directly to wholesalers by Gemini Laboratories, LLC, which is a wholly owned subsidiary of Amneal Pharmaceuticals, and sold to retail pharmacies and consumers nationwide. Labels of the recalled medication can be viewed here.

    Consumers that have the affected Nizatidine Oral Solution should stop using the medication. They should call Inmar at 1-855-319-4807, Monday through Friday from 8 a.m. to 6 p.m. EST or by email at .

    Adverse reactions from the medication can be reported to Amneal Drug Safety at 1-877-835-5472, Monday through Friday from 8 a.m. to 6 p.n EST or by email at .

    There are a number of natural ways to treat indigestion.Photo: Shutterstock

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    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.

    Heartburn Medication Recall And Ndma

    The World Health Organization classifies NDMA as a probable human carcinogen. That is, a product that could cause cancer. NDMA does occur naturally in some foods, water and soil. In the general environment, exposure to NDMA is very slight and should not be a reason for concern. Higher concentrations, such as routinely taking a medication, may cause exposure to exceed safe daily intake limits.

    In recent months, there have been several heartburn medication recalls due to possible contamination with higher-than-safe levels of NDMA. Most notably, Zantac recalls and market removal made headlines across the United States. In addition to the recalls, the FDA has also been investigating possible NDMA contamination among other medications, including Metformin.

    NDMA has the potential to cause cancer if it is consumed in high doses or in moderate doses over an extended period of time. Research suggests that NDMA may cause cancers including:

    • Bladder
    • Pancreas
    • Tongue

    Unfortunately, researchers do not know exactly how risky NDMA is, or how likely it is that someone who consumes it could develop cancer. As the FDA and others continue to investigate the link between NDMA and cancer, your best bet is to monitor your health and talk to your healthcare provider about any side effects or unusual symptoms.

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    What Should I Do If I Have Taken Medications Containing Ranitidine In The Past

    If you or someone you know is currently taking a medication that contains ranitidine, the FDA recommends that you stop taking the medication, properly dispose of it, and not purchase more.1

    Due to the ongoing COVID-19 pandemic, the FDA recommends that individuals dispose of their medications at home, instead of taking them to a drug take-back location.1 For information about how to safely dispose of medications containing ranitidine at home, individuals can review the disposal instructions in their medication package insert or follow the FDAs recommended disposal steps.

    Fda Provides Update On Acid Reflux Medication Recall

    Common Heartburn Medication Recalled Due to Problem with ...

    The US Food and Drug Administration has released an update about the recall of a common heartburn medication.

    The FDA has discovered that some medications used for acid reflux contain low levels of a possible cancer-causing impurity. These medications are found under the names ranitidine and Zantac . These drugs are available over the counter and via prescription.

    These medications work to prevent heartburn and provide relief tied to acid ingestion by reducing the amount of acid the stomach makes. The prescription version is used to treat and prevent ulcers of the stomach it also treats gastroesophageal reflux disease .

    The possible cancer-causing impurity the FDA found is called N-nitrosodimethylamine .

    Two weeks ago, the FDA released information about this discovery and its plan to determine whether the low levels of NDMA found in some ranitidine medications would place people at risk. Now, the FDA is issuing a statement about the voluntary recall of the following:

    • 14 lots of prescription ranitidine capsules distributed by Sandoz Inc.
    • Over-the-counter ranitidine tablets labeled by Walgreens, Walmart, and Rite-Aid and manufactured by Apotex Corp
    • OTC ranitidine tablets labeled by CVS

    The FDA encouraged consumers to refer to the recall instructions provided by the specific company. These details can be found on the FDA’s website.

    Speak with your health care provider if you have any questions.

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    What Should You Do If You Take Ranitidine

    As the FDA and other agencies around the world continue to investigate ranitidine, more details will become available. In the meantime, the FDA is not calling for individuals to stop taking the medication.

    However, for many conditions, ranitidine is only recommended for short-term use. If you have been using ranitidine for a while, now would be a good time to discuss with your physician whether you still need it, and whether you might benefit from ranitidine alternative, including other drug classes or a different H2 blocker. Based on what is known so far, there is no evidence that other H2 blockers or other heartburn medications are affected by NDMA impurities.

    Some people might find antacids useful for relieving heartburn. Lifestyle changes, including avoiding certain foods and beverages, such as spicy foods, large or fatty meals, and alcohol, can also help prevent episodes of heartburn.


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