Fda Announces More Recalls Of Antacids Containing Traces Of Carcinogen
The Food and Drug Administration has recalled several more lots of heartburn medications, including more generic versions of Zantac, that have been found to contain trace amounts of a substance that may be linked to cancer.
The World Health Organization has classified that substance, N-Nitrosodimethylamine , as a “probable human carcinogen.”
The FDA said that Denton Pharma Inc. had recalled several batches of unexpired ranitidine tablets due to the possible presence of NDMA. Ranitidine is the generic version of the popular heartburn drug Zantac.
The recalled batches include certain lots of ranitidine tablets in 150 milligram and 300 mg strengths.
Appco Pharma has also recalled batches of ranitidine because of the potential presence of NDMA. The recalled lots have an expiration date of April or May 2021.
None of the recalled lots has been associated with any injuries or adverse events.
On Wednesday, the FDA also announced that the drug company Mylan has recalled three lots of another antacid, nizatidine, which were also found to contain trace amounts of NDMA. Those capsules, in 150mg and 300mg strengths, were manufactured by Solara Active Pharma Sciences Limited.
Mylan Initiates Voluntary Nationwide Recall of 3 Lots of Nizatidine Capsules, USP, Due to Trace Amounts of NDMA Impurity Found in the Active Pharmaceutical Ingredient Manufactured by Solara Active Pharma Sciences Limited
Canadian Drugmaker Apotex Issues Recall Of Generic Zantac In Us Over Carcinogen Fears
Last week, Walmart Inc joined pharmacy chains CVS Health Corp, Walgreens Boots Alliance Inc and Rite Aid Corp in suspending the sale of over-the-counter heartburn drugs containing ranitidine.
Canadas health authorities have asked makers of the drugs to halt distribution as they gather more information. Last month, regulators in Hong Kong pulled four products, while in Ireland 13 products containing ranitidine were recalled.
The impurity was believed to have been introduced by changes in the manufacturing process.
The Medications Are Used To Treat Pain Heartburn Indigestion And Other Issues
These medications are used to treat common conditions, ranging from indigestion to aches and pains. Milk of Magnesia, for example, is used for the occasional relief of constipation in adults and children 12 years and older. Acetaminophen, which is also known by one of its common brand names, Tylenol, is used for pain relief. The liquid form that has been recalled is used to treat pain from arthritis, muscular aches, backache, the common cold, temporary reduction of fever, among other issues, per the FDA release. Finally, the recalled combination of Magnesium Hydroxide/Aluminum Hydroxide/Simethicone is administered for heartburn relief, an upset stomach, or uncomfortable pressure and bloating.
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Why Was The Original Zantac Taken Off The Market
In 2018, the FDA started releasing warnings that various medications contained a chemical called N-nitrosodimethylamine . A year later, a pharmacy named Valisure discovered ranitidine contained much higher levels of NDMA than what is considered safe. They submitted these findings to the FDA, which ultimately led to the removal of the medication.
Small amounts of NDMA can be found in food, water, and naturally in the environment. Our bodies can break down small amounts of this chemical without problems. But being exposed to too much can be harmful. The biggest concern with NDMA is that it is a known carcinogen, meaning it may raise your risk of developing cancer.
While studies are ongoing, current research shows people who regularly used ranitidine were diagnosed with breast, testicular, thyroid, or kidney cancer more often than people who used other heartburn medications. However, these reports need to be investigated further before experts can say ranitidine was the definite cause.
Several Medications Used To Treat Acid Reflux Recalled Over Probable Carcinogen
Several medications used to treat heartburn and acid reflux are being recalled after manufacturers detected trace amounts of the same probable cancer-causing impurity that prompted earlier recalls of several medications used for similar purposes.
Appco Pharma LLC is voluntarily recalling all quantities and lots of 150mg and 300mg Ranitidine Hydrochloride capsules. The recalled capsules were distributed nationwide.
Ranitidine Hydrochloride capsules are a prescription-only oral medication used to treat duodenal ulcer, benign gastric ulcer, reflux esophagitis, post-operative peptic ulcer, Zollinger-Ellison Syndrome, and other conditions where reduction of gastric secretion and acid output is desirable.
Consumers with questions regarding this recall can contact Appco by calling 253-7735 between 8 a.m. and 6 p.m. More information, including numbers that can be used to identify the recalled drug, can be found by
Northwind brand 150mg and 300mg Ranitidine tablets are also being recalled. The tablets are used to prevent ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.
Customers who purchased the impacted product directly from Northwind can call Northwind at 1-800-722-0772 Monday through Friday, 9 a.m. through 5 p.m. to arrange for product return.
More information, including numbers that can be used to identify the recalled drug, can be found by
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Heartburn Medication Recall : More Acid Reflux Medications Recalled Over Cancer Concerns
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
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.
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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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How Can I Manage Acid Reflux Or Gerd If I Can No Longer Take Medications Containing Ranitidine
Acid reflux and GERD symptoms can be unpleasant to cope with on a regular basis. In addition to living a healthy lifestyle that includes regular exercise and a nutrient-rich diet, there are many medications available to help alleviate the symptoms associated with acid reflux and GERD. Medications such as famotidine , cimetidine , esomeprazole , lansoprazole , and omeprazole are available both by prescription and OTC to help manage these conditions. None of these medications have been found to carry the same risks from NDMA as ranitidine.1 Individuals are encouraged to speak with their health care provider to determine which treatment might work best for them.
For more information about how to live a cancer-fighting lifestyle, explore the NFCRs website.
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Types Of Cancer Zantac Has Been Linked To
The connection between Zantac and cancer has been determined to exist due to the fact that NDMA is carcinogenic. According to the World Health Organization, NDMA consumption is positively associated with gastric and colorectal cancer.
However, as the recall and investigation are fairly recent and lawsuits are currently underway, there are a lot of unknown factors. Some lawsuits are claiming that Zantac and other ranitidine drugs have caused other types of cancer, not limited to bladder cancer, intestinal cancer, stomach cancer, and esophageal cancer.
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.
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Acid Reflux Medication Recalls: What You Need To Know
If youâre reading this, then youâve probably already heard that thereâs new info regarding the ZantacÂ® recall. And you may be asking…so, whatâs next and how does this affect me? Weâre here to guide you through it.
But before we get to that, letâs go over the basics of whatâs happening: The FDA has announced that it is ordering all manufacturers to withdraw both their prescription and over-the-counter variations of Ranitidine . Does this sound familiar? That may be because the drug was recalled back in October after a low level of the presence of NDMA was found in the drug.
We understand that medication recalls can be scary, and while Evens does not have any acid reflux treatments that include it, we’re here to provide you with the information you need to make the best decision for you and your health.
How Concerned Should Patients Be
None of the recalled lots has been associated with any illnesses or injury. And there is no scientific evidence that taking those heartburn drugs, either temporarily or over a period of years, causes cancer.
FDA testing of recalled ranitidine detected NDMA levels similar to the amounts found in grilled and smoked meats.
“The link between NDMA and the development of cancer is still very poorly understood,” said Dr. Scott Gabbard, a gastroenterologist at the Cleveland Clinic. “Patients should not freak out, but I think they should discuss this with their physician.”
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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.
Fda Provides Update On Acid Reflux Medication Recall
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 FDAs website.
Speak with your health care provider if you have any questions.
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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.
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.
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Why Was Zantac Recalled
The FDA announced that small amounts of N-nitrosodimethylamine were found in samples of ranitidine, most commonly marketed as Zantac in the US and Canada. NDMA has been linked to an increased risk of colorectal and uterine cancers. This led to an investigation to answer the questions Is Zantac safe? and Is there a connection between Zantac and cancer?.
While the small amounts initially found are not necessarily dangerous in and of themselves, the FDA also found that over time, the levels of NDMA can increase. At these higher levels, especially when taken for long periods of time when the user is continuously exposed to these larger quantities of NDMA, the risk of developing cancer becomes much higher. Due to this concern, they made the decision to issue a recall of Zantac and ranitidine drugs to protect consumers from this threat to their health.
To help you further understand the dangers of taking Zantac and other ranitidine drugs, lets take a closer look at the two main factors involved ranitidine and NDMA.
What You Need To Know About The April 2020 Zantac Recall
May 06, 2020
On April 1, 2020, the Food and Drug Administration issued a recall of all prescription and over-the-counter ranitidine drugs. This included the brand name medication Zantac, which is commonly used to treat heartburn, stomach ulcers, acid reflux, and gastroesophageal reflux disease . Here is what you need to know about the recall.
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Do Other Heartburn Drugs Cause Cancer
As of April 1, the FDA has not found NDMA in other popular heartburn medications, including:
Its important to monitor the FDAs website for the latest information on drug recalls to keep yourself safe and informed. Your doctor and pharmacist also monitor the latest drug safety information and can be a resource for you.
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What Patients Should Know
- Not all ranitidine medicines marketed in the U.S. are being recalled.
- FDA is not recommending individuals stop taking all ranitidine medicines at this time.
- Consumers taking OTC ranitidine could consider using other OTC products approved for their condition.
- Patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine.
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