Zantac is an over-the-counter medication that is used to treat ulcers and nausea caused by stomach acid. DEA regulation of Zantac in October 2003 led the drug’s pricing to soar, with pharmacies paying up to $1,000 for a single pill. With the high demand and scant supply, many patients were forced into homeopathic medicine as their only option.,
Zantac OTC is a medication that is used to treat heartburn, ulcers and indigestion. It is available as an over-the-counter drug, but it can be prescribed by doctors in certain cases. Read more in detail here: zantac otc dose.
The carcinogen N-nitrosodimethylamine in Zantac, a medicine that has been thought to be safe for decades, may pose previously unknown cancer risks (NDMA). The same contamination has been discovered in blood pressure drugs like Valsartan.
While it’s unclear how Zantac became tainted with NDMA, the discovery has caused a slew of voluntary recalls and the removal of the medicine from shop shelves. The FDA is still looking into the matter. Users of Zantac and its generic counterparts are bringing lawsuits alleging that Sanofi knew—or should have known—about NDMA cancer risks because of probable contaminants in its heartburn treatment. Our lawyers are looking into cancer allegations using Zantac and welcome you to contact us for a free legal consultation.
Approval History of Zantac
Zantac has been on the market for over four decades, first as a prescription ulcer medicine and then as an over-the-counter (OTC) heartburn medication.
Zantac was created in 1975 by Glaxo Holdings (now GlaxoSmithKline) as a rival to the extremely successful ulcer medication Tagamet. Zantac was originally released in the United Kingdom and Italy in 1981, and it received FDA clearance in the United States in 1983. Zantac became the best-selling medicine in the world and one of the first to achieve $1 billion in sales in 1988.
When Glaxo’s patents on ranitidine expired in 1997, generics were available. Over-the-counter versions of Zantac were authorized to treat heartburn starting in 2004. Doctors continue to use Zantac to treat stomach ulcers, gastroesophageal reflux disease (GERD), and disorders where the stomach generates too much acid. Children and newborns are administered certain forms of the medication. Doctors issue more than 15 million ranitidine prescriptions each year, according to WebMD, in addition to the numerous individuals who purchase it over-the-counter.
How Does Over-the-Counter Zantac Work?
Ranitidine belongs to the histamine-2 (H2) blocker family of medicines. Histamine, a naturally occurring substance that activates H2 receptors and triggers cells in the stomach to create acid to facilitate food digestion, is generally acted upon by H2 receptors in the stomach lining. Ranitidine inhibits the formation of stomach acid by blocking H2 receptors. This may help to ease indigestion symptoms, minimize acid reflux into the esophagus, and enable ulcers to heal.
Recalls of Zantac and an FDA investigation
On September 9, 2019, an online pharmacy will be launched. Valisure filed a citizen petition with the FDA, demanding that the agency issue a recall and stop selling all lots of ranitidine-containing products in the United States. “Extremely high quantities” of NDMA were found in “every batch tested, across numerous manufacturers and dosage forms,” according to Valisure. Valisure allegedly found NDMA levels that were more than 31,000 times greater than the FDA’s daily NDMA limit.
Following that, the FDA released a statement declaring an inquiry into the matter. Sanofi and generic ranitidine producers have also initiated voluntary recalls since then. The complete list of recalled ranitidine products may be seen here. In addition, sales of generic and brand-name Zantac have been halted at CVS, Walgreens, and Walmart.
FDA gave an update on their inquiry on November 1, 2019. It noted that although its own testing revealed far lower NDMA levels in ranitidine products than Valisure first reported, “certain levels still exceed what the FDA deems appropriate for these medications.”
How Did Zantac Become NDMA-Contaminated?
It’s unclear why NDMA contaminants have been discovered in ranitidine medications. The ranitidine molecule, which has both a nitrite (N) and a dimethylamine (DMA) group that may combine to generate NDMA, is thought to be the cause, according to Valisure’s experts.
“We discovered that the ranitidine molecule has an intrinsic instability. “It simply breaks down into NDMA,” explained David Light, Valisure’s CEO. “And this isn’t Valisure shouting about anything we came upon. This issue’s basis has been in place for decades. “All we’re doing is connecting the dots.”
Others claim that the problem stems from the manufacturing process. This was the situation with blood pressure medications that were tainted as a result of difficulties at Chinese and Indian factories. The ranitidine contamination concern, according to FDA spokesman Jeremy Kahn, is connected to manufacturing, not the ranitidine molecule. “We would have observed the negative effects a long time ago if there had been an issue with the chemical,” Kahn added.
If I take Zantac, am I putting myself at risk?
The amounts of NDMA discovered in ranitidine, according to the FDA, are comparable to those found in commonly consumed meals such as grilled or smoked meats. “To have 3 mg of carcinogen being able to be generated by ranitidine is really worrying to us,” Valisure’s David Light stated in a video, based on the quantities of NDMA detected in ranitidine during testing.
Patients’ levels of worry are determined not just by the quantity of NDMA in ranitidine, but also by how long they had been on Zantac. Patients who use ranitidine for a long period of time (more than a month) are at a higher risk than those who take it for a short period of time, according to gastroenterologist Emeran A. Mayer.
Overexposure to NDMA may cause skin yellowing, nausea, fever, vomiting, stomach cramps, and disorientation. NDMA exposure at high levels may impair kidney and lung function. NDMA has been linked to bladder cancer, liver cancer, testicular cancer, lung cancer, and other cancers in animals.
I’m not sure what I should do next.
If you use Zantac and get NDMA poisoning symptoms, see your doctor very soon. Even if you don’t have symptoms, the FDA suggests that patients discuss alternate treatment choices with their doctor, since there are many ranitidine alternatives that haven’t tested positive for NDMA.
Anyone who has developed cancer or other health problems as a result of using Zantac or NDMA should see an attorney about their legal possibilities. Despite the fact that ranitidine has been identified as a source of NDMA creation by several study groups for years, Zantac’s producers never addressed the possible NDMA danger presented by Zantac products.
Our lawyers are prepared to pursue cases on behalf of impacted people when further information concerning the relationship between Zantac and cancer becomes available. Make an appointment for a free case evaluation.
Zantac OTC is a medication that is used to treat ulcers. It comes in the form of a tablet, which can be taken with or without food. The dosage for Zantac OTC varies depending on the patient’s weight and age. Reference: zantac dosage.
Frequently Asked Questions
Can you buy Zantac over-the-counter?
A: No, you cant buy Zantac over-the-counter. This is due to the fact that it requires a prescription in order for pharmacies to dispense this drug.
When did Zantac become OTC?
A: Zantac became over-the-counter in 1989, after being an OTC drug since 1971.
Is Prilosec the same as Zantac?
A: There are a few differences between the two. Zantac is made out of zinc and Prilosec has no zinc in it, but both drugs work to reduce stomach acid levels by slowing down the emptying process.
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