Popular heartburn medicine Zantac has recently been the focus of numerous recalls. Consumers who currently use or previously used Zantac are worried about possible health effects as a result of the recall. The manufacturer of ranitidine, the generic equivalent of the medication that goes by the name Zantac, has also issued recalls for their products. Customers might be wondering why Zantac is being recalled and what they should do in response.
Zantac is a histamine-2 blocker, sometimes referred to by its generic name ranitidine hydrochloride, a medication that works to prevent heartburn by lowering the level of stomach acid.
Zantac is used to treat heartburn as well as related disorders such as Zollinger-Ellison syndrome, ulcers, and gastroesophageal reflux disease (GERD). Sanofi is the company that produces and sells Zantac.
Why is Zantac being recalled?
What exactly is the big problem, and why is Zantac being recalled? NDMA (N-nitrosodimethylamine), a potential human carcinogen, may have been present in Zantac, so some manufacturers are removing it from the market to better protect patients. High NDMA concentrations, according to the World Health Organization, can cause colorectal or stomach cancer.
The most typical sources of NDMA, an environmental pollutant, are food, water, and soil. Although the EPA now only permits its use for research, the chemical was purportedly formerly used to produce rocket fuel.
Sadly, there are worries that manufacturing procedures or chlorinating drinking water could produce NDMA. This inadvertent contamination could result in the discovery of NDMA in unanticipated locations.
The issue is that Zantac may have been poisoned with unsafe doses of the chemical, even though NDMA is a common ingredient that is even present in some foods, according to The Deseret News.
The early Zantac recalls were voluntary, which means that manufacturers started the process themselves rather than waiting for a regulator like the U.S. Food and Drug Administration to order a recall (FDA). On Dec. 4, 2019, the FDA said that it had requested ranitidine producers test every batch of the drug for NDMA contamination before making it available to customers. In cases where NDMA levels are found to be greater than 96 nanograms in a single day or 0.32 parts per million, the FDA has encouraged businesses to recall their products.
But if there isn’t any evidence of NDMA contamination, are Zantac goods being recalled?
In several instances, pharmacies ceased selling the medicine to safeguard their customers. Retailers like CVS, Walmart, and Walgreens removed their own ranitidine drugs from shelves in addition to other similar prescriptions.
Additionally, the FDA intervened after the initial voluntary recall of Zantac. The FDA demanded that all Zantac medicines, including brand-name and generic, be taken off the market right away until the contamination’s source could be identified and contained in April 2020.
Should I discard my medication in light of the Zantac recall?
The FDA emphasizes the significance of adhering to a treatment plan up to a replacement that can be located by a pharmacist or doctor, despite the fact that Zantac recalls may be frightening. The agency, as always, advises patients to discuss any concerns they may have with their healthcare team rather than changing their treatment plan in response to recalls.
Is Zantac subject to a recall? Yes, however, it’s crucial to remember that, to reduce unnecessary risk, adjustments to your treatment should always be approved by your doctor.
However, you might wish to discuss viable alternatives with your doctor. Testing of Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), and Prilosec (omeprazole) samples, according to the FDA, has not revealed any NDMA contamination. Ranitidine, which is also sold in prescription strength to treat ulcers, heartburn, and acid reflux issues, has all of these over-the-counter substitutes.
Zantac was tainted in what way?
Why is Zantac being recalled when NDMA has not been identified in the products, some people may be wondering? According to The Deseret News, a recent study has shed light on how the medicine might have initially become infected. According to a study by Emery Pharma, Ranitidine may produce NDMA if it is overheated. “NDMA in this circumstance… is not a contaminant in the medicine; it is being generated from the drug itself,” says chemist Ron Najafi.
According to CBS News, the FDA’s permissible daily limit for NDMA is 96 nanograms. According to a recent study, after being stored at ambient temperature for 12 days, the ranitidine’s NDMA content increased to 25 nanograms, which is still considerably below the FDA’s limit. However, when heated to 158 degrees, the ranitidine’s NDMA content increased to 142 nanograms, which is far more than the FDA’s limit. According to CBS News, if the drug was, for instance, left in a warm automobile during the summer, it wouldn’t take long for the temperature to reach 158 degrees. It seems likely that NDMA will develop at this temperature.
There are still unsolved questions despite the study’s fresh information; Dr. Janet Woodcock, the FDA’s director of drug assessment and research, provided the explanation. According to reports, it has not yet been determined if ranitidine must be kept cold to prevent the drug from turning into NDMA.
According to CBS News, the FDA is also looking into whether the medication can turn into NDMA after consumption and why some batches of ranitidine contained more NDMA than others. Name-brand Zantac manufacturer Sanofi has instituted a recall and is testing its goods. Other pharmaceutical companies have called back generic versions of Zantac.
According to the Deseret News, NDMA has also been discovered in valsartan, a blood pressure medication. Later, losartan and irbesartan were added to the valsartan recall.
What reactions are consumers having?
In October 2019, Newsweek opined that the Zantac recall might result in a class action lawsuit. Experts considered what that might entail.
Recalls have been caused by the finding that NDMA may also have contaminated other medications. According to Newsweek, class action lawsuits are being considered in these instances. Because these medications are manufactured in large quantities, a class action lawsuit may be an effective approach to seek justice for many and maybe help those who need it.
In light of recent reports that Zantac may have been tainted, specialists now question whether the same thing will transpire. According to Newsweek, it is yet too early to know, says Katharine Van Tassel, a visiting professor of law at Case Western Reserve University School of Law.
She doesn’t believe there is sufficient proof to prove that the NDMA found in ranitidine (Zantac products) can cause cancer. Others in the field are said to concur, including Wake Forest University School of Law Professor Michael D. Green. In order to assess whether there is enough of the contaminant in the medication to put patients at risk, he concluded by noting that “the dose makes the poison” and that it is “essential to figure out what the amount is.”
Dr. Van Tessel continued by outlining the potential difficulties in asserting a Zantac claim. She pointed out that it would be the patient’s responsibility to provide evidence linking their cancer to their use of Zantac rather than to some other aspect of their lives. According to her, in some circumstances, this necessitates attributing 51% of the reasons in their situation to the usage of Zantac rather than to other factors.
Despite Dr. Van Tessel’s skepticism, a number of individual and class action lawsuits have been brought by patients who assert that taking tainted generic Zantac over an undetermined period of time increased their chance of developing cancer and caused them to get bladder or liver cancer.
A victim and his wife’s Zantac complaint claims that the drug makers may have known about the possible contamination for years. Plaintiff Douglas R. claims that the makers of ranitidine may have been aware of the hazards connected to the carcinogen contaminant but neglected to alert the FDA to these risks when he filed his lawsuit against numerous ranitidine manufacturers in April.
He alleges that Sanofi prioritized money over people for years and may have exposed millions of victims to carcinogenic substances. After taking Zantac on a regular basis, Douglas was diagnosed with a rare type of bladder cancer.
After contracting illnesses like stomach cancer, bladder cancer, colorectal cancer, kidney cancer, prostate cancer, and esophageal cancer, a number of additional plaintiffs in places like Illinois, Ohio, New Jersey, and Colorado have also filed cases against the medication manufacturers.
In these cases, the plaintiffs are suing the manufacturers for additional punitive damages, damages for their injuries, pain and suffering, and medical costs.