Zantac, also known by its generic name Ranitidine, is a drug sold by pharmaceutical manufacturers Sanofi and Boehringer Ingelheim. Previously considered to be a very safe and effective drug, Zantac is sold both as a prescription and as an over-the-counter drug.
Ranitidine belongs to the class of drugs called histamine-2 _H2) blockers and is used to prevent and relieve heartburns, sour stomachs, and acid ingestions brought upon by consuming certain foods and beverages.
Prescription strength ranitidine is also used to treat patients with more serious gastrointestinal disorders like peptic ulcers and prevent them from recurring once the stomach and intestines have healed.
The medication is also commonly used to treat and esophageal problems like gastroesophageal reflux disease (GERD), erosive esophagitis, and Zollinger-Ellison syndrome — a condition involving the oversecretion of gastric acids caused by tumors or hyperplasia of the islet cells in the pancreas, that result in recurring ulcers.
It also relieves symptoms of these disorders, including chronic cough, stomach pains, and difficulty in swallowing, and prevents bleeding from the stomach, esophagus and duodenum.Side Effects
Zantac contains a potent hepatoxin known as NDMA (N-nitrosodimethylamine). Both short term and long term exposure to this toxin can potentially cause a number of serious health complications.
Gastrointestinal Issues: This includes severe stomach pain and abdominal cramps, which may be accompanied by constipation, nausea, and vomiting. Some people have also experienced diarrhea and acute pancreatitis.
Cardiovascular Issues: Cardio issues include chest pain, heart arrhythmias or tachycardia such as slow, fast, or irregular heartbeats, extra heartbeats in ventricle, and atrioventicular block. In rare cases, it can also cause asystole — the absence of ventricular contractions — or vasculitis, inflammation of the blood vessels.
Psychiatric Issues: Zantac may also be linked with some mental issues like confusion, depression, agitation, hallucinations, and in some less frequent cases, loss of libido.
Nervous Issues: Administration of Zantac may potentially cause severe headaches, dizziness, vertigo, intense fatigue and sleepiness, and reversible involuntary movement disorder.
Hepatic Issues: Changes in liver function, increased levels of the enzyme ALT indicating a damaged liver, liver fibrosis and scarring, jaundice, yellow eyes and skin, hepatitis, enlarged liver, and tumor.
Renal Issues: Some patients also experienced elevation in the levels of creatinine, acute interstitial nephritis, and dark urine.
Respiratory Issues: Some respiratory issues include bronchospasm, a sore throat that would not go away, yellow or green mucus production, pneumonia, and shortness of breath.
Ocular Issues: Some patients reported temporary blurred vision after taking Zantac.
Hematologic Issues: Some rare but serious side effects of Zantac may also include low levels of platelets in the blood, decrease in the number of white blood cells and thrombocytes, decrease in the number of red blood cells, and easy bruising and bleeding.
Genitourinary Issues: Some issues include enlarged breasts, a milky discharge from the nipple, and temporary impotence.
Dermatologic Issues: These include allergic reactions like itching, skin rashes, angioedema, which causes swelling of the face, tongue, and/or throat, and hair loss.
Hypersensitivity: Some patients have suffered anaphylactic shock after a single dose.
Other issues: Signs of infections like chills and fevers and deficiency of vitamin B-12.Interactions
Zantac is purported to decrease stomach acid and hence it can have an adverse effect on the body’s ability to absorb some products that need stomach acid to work. These include products like delavirdine, atazanavir, dasatinib, ketoconazole, itraconazole, and pazopanib, among many others. This means that the body will take a longer amount of time to get rid of these products from the system, resulting in increased risk of overdose.
Zantac should also not be used with other products that contain ranitidine or other histamine-2 blockers like famotidine, cimetidine, and nizatidine as well as blood-thinners like warfarin (Coumadin) and anitdepressants like triazolam (Halcion).
The drug may also interfere with laboratory test results, causing false test results.
Additionally, you should not consume alcohol while taking Zantac since it can cause risk of stomach damage.Overdosage
Zantac is taken as a tablet, effervescent tablet, effervescent granules, or syrup. For GERD and ulcers, the typical dose is 150 milligrams twice a day or 300 milligrams at night. For heartburn, the dosage is 75 to 150 milligrams once or twice daily, some time before a meal that can cause heartburn.
For erosive esophagitis, 150 grams of Zantac four times a day is recommended.
For Zollinger-Ellison syndrome, the dosage can be 6 grams a day.
If you missed taking a dose on time, take it if not too much time has passed. If you are closer to the time of your next dose, skip the dose. Never double dose to compensate for a missed one.
Overdosing can have serious symptoms like problems in breathing, difficulty walking, severe dizziness and fainting.
If you experience these symptoms, contact a medical health professional or 911 immediately.
Manufacturers Sanofi and Boehringer Ingelheim stated that the drug does not have any serious side effects. However, since the 1980s, there have been several studies that showed the link between NDMA found in ranitidine and cancer. Increasing evidence also shows that the pharmaceutical giants that made Zantac knowingly concealed the cancer link from the government and customers who took the drug for GERD, sour stomach, heartburn, gastric and peptic ulcers and other gastric disorders.
It is possible that the deception was made so that the companies could collect unprecedented profits of $1 billion from Zantac, which became the first drug to generate such huge profits in sales.What Kind Of Cancer Is Zantac Potentially Associated With?
On September 13, 2019, the Food and Drug Administration reported that Zantac contained the carcinogenic impurity NDMA in ranitidine, the active ingredient in Zantac.
The amount of NDMA was between 3,000 to 26,000 times higher than the FDA approved limit for traces of NDMA.
NDMA is a compound that is used in the industrial lubricant and aviation industry. It is a by-product of many industrial processes like treatment of wastewater that contains nitrogen or gasoline refining. It is also used to induce carcinogenesis in laboratory testing for rats, as part of cancer research.
It is also a contaminant in a number of processed food products like cured meat, vegetables and dairy and also is found in tobacco fumes.
According to the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA), NDMA is an “extremely hazardous” substance. As such, the companies that use this toxin operate under strict guidelines on how to produce, store and utilize NDMA.
The association between NDMA and cancer goes back decades and due to this, Zantac may be associated with an increased risk of cancer, including:
- Bladder cancer
- Liver cancer
- Kidney cancer
- Esophageal, throat, or nasal cancer
- Intestinal cancer
- Breast cancer
- Brain cancer
- Lung cancer (even in non-smokers)
- Pancreatic cancer
- Ovarian cancer
- Prostate cancer
- Uterine cancer
- Thyroid cancer
- Stomach cancer
- Testicular cancer
If the cancer was diagnosed six months after the patient stopped taking Zantac, the drug must have been taken for over one year on a regular basis.
The FDA has been testing and evaluating the exact cause of how Zantac gets contaminated with NDMA after it was prompted by third-party laboratories.
The agency found out that when ranitidine comes in contact with water, it undergoes a chemical reaction that results in the formation of NDMA.
NDMA levels increase at a very significant level when ranitidine is stored at higher temperatures, including the temperature the drug is exposed to when it is being distributed or sold to customers.
Worse, NDMA levels even increase in ranitidine during normal temperature and storage conditions and will be elevated in products that have been manufactured a while back. The older the ranitidine product is, the greater will be the levels of NDMA.
This means the level of NDMA in drugs containing ranitidine, like Zantac, can be above the acceptable limit prescribed by the FDA.Contamination of NDMA On Another Class of Drugs
The FDA has also compared the likely effect of NDMA found in Zantac with NMDA found in another class of drugs known as the angiotensin receptor blockers.
Diovan, also known as valsartan is an angiotensin receptor blocker that is used to treat high blood pressures and other cardiovascular conditions. These drugs were also recalled in 2019 because they were contaminated with NDMA and other impurities.
According to the FDA research, if 8,000 people took the highest dose of Diovan (320 mg) containing the toxin every day for four years, these 8,000 people will potentially suffer from an additional case of cancer.
However, the contamination level of NDMA in valsartan pale in comparison to Zantac. Based on this research, the effect of NDMA on consumer health can be nothing short of catastrophic.
However, all of the valsartan products seemed to have been made for active pharmaceutical ingredients which were imported from India or China. This is not the case with Zantac, though, since evidence suggests that contamination originated within the finished drug itself. This suggests that the drug becomes unstable under certain conditions.
Plaintiffs accuse Sanofi and Boerhringer Ingelheim of creating, deceptively marketing, and selling a drug that the pharmaceutical companies knew, or should have known, to be contaminated with a powerful industrial toxin and carcinogen. They allege that the companies failed to disclose the risks to the government and the public at the expense of human lives for paltry material gains.Why Was Zantac Recalled?
The FDA announced on Sept. 13, 2019 that it will be investigating the risks of people getting cancer from taking Zantac. To do that, the agency tested Zantac 150 tablets, which are commonly used by people with heartburn.
At that time, the agency found NMDA in ranitidine in low levels but did not have enough evidence to recommend customers stop taking the drug or order that manufacturers recall the defective product.
Even so, some manufacturers issued voluntary recalls, including Sanofi, and some pharmacies removed Zantac from their shelves.
Meanwhile, the FDA continued with its investigations while issuing a warning in the interest of public safety to evaluate the potential risks of the drug and to consider other prescription or over-the-counter drug treatments.
It also asked companies that made ranitidine and other similar medications like other H2 blockers and proton pump inhibitors (PPI), to test the stability of their product on low heat near to body temperature. The FDA only asked for tests as a precautionary measure and so far, there were no indications that these other products were similarly affected by contamination.
However, on April 1, 2020, the FDA issued an immediate national recall for all Zantac products, stating that NDMA concentration in the drug increased over time and was a risk to public health.
The move came after the FDA found that the tablets contained over 3,000 times and as much as 26,000 times of NDMA levels that are deemed safe. The FDA acceptable level of daily intake of NDMA is set below 100 nanograms. This means that a single 150-gram tablet of Zantac contains over 2.5 million nanograms of NDMA.
If you compare it with the recommended dose to treat patients with ulcers (300 grams), it means they may be consuming as much as 5 million nanograms of NDMA in a single day.
Research has also shown that patients who used ranitidine had a 400-fold increase in the concentration of NDMA in their urine. Plaintiffs allege that Sanofi and Boehringer Ingleheim failed to alert the public of the dangers of the hepatoxin by posting warnings on the packaging or through any other means and if the patients had known of the risk, they would not have purchased the product.
With the announcement, the FDA sent letters to all companies that create ranitidine ordering that they take out all of their products from the market. The agency also strongly advised customers to stop taking any over-the-counter ranitidine-based tablets or liquids, dispose of them properly and not buy any more of the product.
For people who need to treat their conditions, the FDA advised speaking to their healthcare professional and using other over-the-counter products that do not carry health risks and which provide the same benefits that ranitidine purported to provide.
As of yet, the FDA has not found any NDMA contamination in esomeprazole (Nexium), famotidine (Pepcid), cimetidine (Tagamet), omeprazole (Prisolec) and Iansoprazole (Prevacid).
Prior to the FDA’s national recall of ranitidine, many other pharmaceutical giants issued recalls of their own products as well, including Sandoz (Novartis), GlaxoSmithKline, and Apotex, after two laboratories, Valisure and Emery Pharma conducted batch tests of the ranitidine and found unacceptably high concentration of NDMA in it.
Both these companies filed citizens’ petitions with the FDA which urged the agency to hasten a recall and suspend Zantac sales.
Retailers like Walgreens and CVS also pulled the prescription and OTC Zantac from their shelves, citing their link to cancer and requested their customer to return the drugs and get a full Zantac refund.
At least 22 countries have now halted distribution and recalled ranitidine products due to cancer concerns, including US, Canada, UK, Hong Kong, Taiwan, Pakistan, and India, as the FDA asserts the ban is permanent.