Whats The Link With Cancer
Ranitidine is currently in the news after the Australian Therapeutic Goods Administration issued an alert stating many formulations of the drug were contaminated with a chemical called N-nitrosodimethylamine, abbreviated as NDMA. This should not be confused with the illegal party drug MDMA , which is a completely different chemical.
Contamination of ranitidine formulations is a problem because the World Health Organisation lists NDMA as a probable carcinogen, meaning it may cause cancer.
But its important to note most people are exposed to NDMA as part of their normal lives. NDMA can be found in cooked and smoked meats, from smoking cigarettes, beer, and even some toiletry and cosmetic products.
Its not clear how the ranitidine formulations have become contaminated with NDMA. A similar chemical, dimethylamine, is used in the synthesis of ranitidine, and it may be possible some NDMA is created when the drug is made. Alternatively, ranitidine may be broken down, producing NDMA, during storage.
It will be important to determine the source of the contamination if new formulations are to be made free from NDMA.
The response in many countries has been the recall of ranitidine formulations. In the United States, the companies Sandoz and Apotex have voluntarily withdrawn their brands from sale. In Canada, the government has asked companies to stop distributing the medicine.
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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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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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:
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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Which Acid Reflux Medications Have Not Been Recalled
Luckily, there are still many safe medications for acid reflux that have not been recalled. These medications include PPIs like esomeprazole , and omeprazole , as well famotidine , cimetidine , and lansoprazole . Not to mention, antacids are still safe to use.
Oh, and if you are disposing of your existing pills containing nizatidine, please read the FDAâs instructions on how to do so safely.
And thatâs the story for now. Weâll make sure to keep this updated as more information comes in.
The information provided in this article is not a substitute for professional medical advice, diagnosis, or treatment. You should not rely upon the content provided in this article for specific medical advice. If you have any questions or concerns, please talk to your doctor.
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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 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.
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These Common Heartburn And Pain Meds Were Just Recalled Fda Warns
Ailments such as heartburn, indigestion, and general aches and pains are experienced by millions of people on a daily basis. That’s why medications used to treat these pesky issues are relied on as tried and true methods to knock out a headache or calm an upset stomach. However, sometimes otherwise reliable treatment approaches can do more harm than good. Read on to learn more about the U.S. Food& Drug Administration’s recent recall warning for three common medications.
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.
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Have Questions About A Heartburn Medication Recall
If you suffer harm or require medical treatment due to a recalled medication, you may be able to pursue compensation. Drug and Device Watch can help you determine if you qualify to file a legal claim against a pharmaceutical company whose negligence caused you to suffer. If you have an actionable claim, you may be able to recover damages, such as the cost of your medical treatment, pain and suffering and more.
To find out what your options may be and to learn more about your legal rights, contact Drug and Device Watch. Request a free legal consultation by calling 1-888-458-6825. You can also complete our online form to learn more.
The Fda Announces Two More Antacid Recalls Due To Cancer Risk
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That burning feeling in your chest after you eat a heavy meal could be heartburn. Or it could be worry over the drugs youve taken to treat that heartburn. Among the top medical stories of 2019 was the discovery of contaminants in common medicines, and ranitidinebest known as Zantactook up a large share of those headlines. A cancer-causing substance known as NDMA has been repeatedly found in one of the most popular antacid drugs in the United States.
The scary news continues in 2020. On Wednesday, the Food and Drug Administration announced voluntary recalls of prescription forms of ranitidine by two generic drug companies, Appco Pharma and Northwind Pharmaceuticals, bringing the total number of ranitidine recalls to 14 in the past five months. The agency also reported that Mylan Pharmaceuticals recalled three lots of Nizatidine , a similar drug, again because of NDMA.
This weeks recalls are a new cause for alarm for the 15 million Americans who take ranitidine at prescription levels, and the millions more who regularly take lower-dose, over-the-counter versions. More than 60 million Americans experience heartburn at least once a month. Zantac was once the best-selling drug in the world.
For people worried about past use of Zantac and cancer risk, heres some back story and a bit of perspective.
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Plastikon Healthcare Has Voluntarily Recalled Three Medications Citing Risk Of Intestinal Distress
Due to microbial contamination, as well as “failure to properly investigate failed microbial testing,” the pharmaceutical company Plastikon Healthcare is recalling three lots of Milk of Magnesia oral suspension, one lot of Acetaminophen, and six lots of Magnesium Hydroxide/Aluminum Hydroxide/Simethicone. These medications are solely for institutional use, meaning they are sold to hospitals and clinics across the U.S., but cannot be bought directly by consumers.
The FDA announced the voluntary recall on March 24, warning consumers that the use of the products could cause illness “due to intestinal distress” in the form of diarrhea or abdominal pain. On a more serious note, those with compromised immune systems are at greater risk if given these medications, the agency warned. According to the statement announcing the recall, these individuals “have a higher probability of developing a wide-spread, potentially life-threatening infection when ingesting or otherwise orally exposed to products contaminated by micro-organisms.”
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.
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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.
What Do We Know So Far
On September 13, 2019, the FDA announced that preliminary tests found low levels of N-nitrosodimethylamine in ranitidine, a heartburn medication used by millions of Americans. This week, the drug companies Novartis and Apotex announced that they were recalling all of their generic ranitidine products sold in the US.
These announcements came after a Connecticut-based online pharmacy informed the FDA that it had detected NDMA in multiple ranitidine products under certain test conditions.
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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 askingso, 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, were here to provide you with the information you need to make the best decision for you and your health.
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.
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What You Should Do
- Talk to your doctor or pharmacist at your earliest convenience about alternative, non-ranitidine treatment options appropriate for your health circumstances. There are many prescription and over-the-counter drug alternatives in Canada that are authorized for the same or similar uses as ranitidine.
- Individuals taking a prescription ranitidine drug, including a recalled product, should not stop taking it unless they have spoken to their health care provider and obtained alternative treatment, as the risk of not treating the condition may be greater than the risk related to NDMA exposure.
- Contact your health care provider if you have taken a ranitidine product and you have concerns about your health.
- Report any health product adverse events or complaints to Health Canada.
What Is Ndma And What Harm Can It Cause
NDMA is an environmental contaminant that is found in water and foods, including dairy products, vegetables, and grilled meats. Its classification as a probable carcinogen is based on studies in animals studies in humans are very limited.
It is important to know that the NDMA in ranitidine products does not pose any immediate health risks. Neither the FDA nor Novartis/Sandoz or Apotex have received any reports of adverse events related to NDMA found in ranitidine. Although classified as a probable carcinogen, NDMA may cause cancer only after exposure to high doses over a long period of time. NDMA is one of the same impurities that was found in certain heart medications beginning last year and that resulted in the recall of many products.
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