If you or someone in your family takes Zantac (ranitidine hydrochloride), you may have heard that some generic manufacturers have issued generic Zantac recalls. While more disturbing Zantac news is coming in every day, here’s what you should know.
Which Zantac Has Been Recalled?
According to the news media, three drug manufacturers—Apotex, Sandoz (Novartis), and GlaxoSmithKline (GSK)—have recalled generic Zantac sold at Rite Aid, Walgreens, and Walmart. Some versions of generic Zantac (ranitidine hcl) have been recalled in Canada and Europe.
Did the FDA Issue a Zantac Recall in 2019?
The U.S. Food and Drug Administration (FDA) is warning consumers that testing of the popular heartburn medication Zantac (generic ranitidine) revealed a known cancer-causing chemical, N-nitrosodimethylamine (NDMA) at more than 3,000 times the legal daily intake limit. In a statement issued in October of 2019, the FDA noted, “To date, the agency’s early, limited testing has found unacceptable levels of NDMA in samples of ranitidine.”
While the FDA is investigating the cancer link, the agency has not yet issued a formal Zantac recall 2019 notice. Despite the FDA’s reluctance to issue a recall for Zantac, retail outlets like Walgreens, Walmart, Rite Aid, CVS and others are pulling the popular medication from shelves; generic drug makers like Sandoz (a division of Novartis), GSK, and Apotex have issued generic Zantac recalls; and nearly two dozen countries have taken action to stop or restrict sales of the popular medication.
What is the Problem with Zantac?
Connecticut-based online pharmacy Valisure tests medications for consistency and quality issues. During testing, the company discovered extremely high levels of NDMA “in every lot tested, across multiple manufacturers and dosage forms of the drug ranitidine.”
NDMA is a chemical that the FDA, Environmental Protection Agency (EPA), and World Health Organization (WHO) all classify as a substance capable of causing cancer.
Valisure’s finding was consistent with studies from Stanford University and elsewhere, which found that NDMA in Zantac was likely due to the “inherent instability” of the ranitidine molecule.
“There’s no acceptable cancer risk for a drug like this,” said David Light, CEO of Valisure.
Valisure reported its findings to the FDA in June of 2019, and three months later, the company petitioned the FDA to issue a Zantac recall and suspend all sales:
“Combined with other data from Valisure and the scientific works of Stanford University and others, the evidence presented shows this instability and the resulting NDMA occurs in the conditions representative of those in the human body and builds a compelling case for ranitidine being a likely human carcinogen.”
What is Zantac Used for?
Glaxo Laboratories (now GlaxoSmithKline, or simply GSK) developed Zantac (ranitidine hydrochloride), and it was first used commercially in 1981. In the years since, Pfizer, Johnson & Johnson, Boehringer, and Sanofi have controlled the over-the-counter Zantac rights.
People commonly use Zantac for heartburn, acid reflux, and other stomach, throat and gastrointestinal issues. Others use Zantac for allergies to supplement their treatment regimen. Zantac dosage varies between 75 and 150 mg tablets, though some patients take a once-daily Zantac 300 mg dosage.
Zantac belongs to a class of drugs known as histamine-2 (H2) blockers. Designed to decrease the production of stomach acid, H2 blockers are approved by the FDA for several conditions, including:
- the treatment of gastroesophageal reflux disease (GERD)
- the treatment of erosive esophagitis (inflammation of the esophagus)
- short-term treatment of active duodenal ulcers (ulcers on the upper part of the small intestine (duodenum)
- maintenance therapy for duodenal ulcers
- treatment and maintenance therapy for gastric ulcers (ulcers on the inside of the stomach)
Other drugs in the H2 blocker group include Pepcid and Tagamet.
2018 Valsartan NDMA Recall
In 2018, some companies issued recalls after the discovery of high levels of NDMA in multiple generic forms of the blood pressure drug valsartan. The levels of NDMA in these products, however, paled in comparison to that of Zantac.
The 2018 recalls were reportedly linked to NDMA that formed during manufacturing after active ingredient suppliers in India and China sold components of the medication to generic drug makers. Government officials have not commented on how NDMA ended up in the drugs.
Zantac Cancer Lawyers Call for FDA Ranitidine Recall
While the FDA investigation into this serious public health issue is a necessary step, the Zantac cancer lawyers at Baum, Hedlund, Aristei & Goldman believe the agency is downplaying the true danger of the Zantac cancer risk by claiming the amount of NDMA found during testing is low.
Regulators outside of the United States caution patients against taking Zantac, noting the availability of safer alternatives. The FDA, on the other hand, is dragging its feet on issuing a Zantac recall. Simply put, by telling consumers that they do not need to stop taking Zantac or Zantac OTC generics, the FDA is confusing the American public, not protecting it.
Free Zantac Lawsuit Review
If you or a member of your family took ranitidine (Zantac) and developed cancer, you need an experienced personal injury attorney on your side. The Zantac cancer attorneys from the law firm of Baum, Hedlund, Aristei & Goldman have years of experience holding big corporations accountable for concealing the dangers of consumer products.
“Having represented people whose lives were turned upside down by the deception of a corporate giant like Monsanto, I can say with 100% certainty that if these cancer-stricken people were told, if they were given the choice to avoid a product that could cause them to develop cancer, they would never have taken Zantac,” says R. Brent Wisner, award-winning trial attorney at Baum, Hedlund, Aristei & Goldman.
Brent served as co-lead trial counsel in two cases against the Monsanto Company that resulted in verdicts worth $289.2 million and $2.055 billion. The jury verdicts in these cases were hard-earned legal victories that will have a lasting impact for our clients, their families, and public health.
Since 1973, our firm has obtained more than $4 billion in verdicts and settlements on behalf of clients across all areas of practice. The firm’s track record of success speaks for itself: we know how to win big cases against big companies.
For a free Zantac lawsuit review, click here to fill out our contact form or call us at 800-827-0087.