You may recall reading about the massive Zantac recall that made headlines in September 2019. Several major drug manufacturers recalled Zantac and generic ranitidine products after the U.S. Food and Drug Administration (FDA) became aware that the products may be contaminated with a probable human carcinogen. In the months since, the FDA has continued to investigate the potential for contamination, and now is calling for all Zantac and ranitidine products to be removed from the market.
At MedMalFirm.com, we want our readers to be informed about changes in the healthcare environment. In today’s post, our Houston medical malpractice attorney discusses the Zantac recall, the FDA’s call for removal and what you need to know as a consumer.
Zantac Recall Background
In 2019, the FDA was made aware that independent laboratory tests found N-Nitrosodimethylamine (NDMA) in ranitidine products. NDMA is a probable human carcinogen and environmental hazard. NDMA is the same contaminant that was found in blood pressure medications, which resulted in massive recalls of those products as well.
Ranitidine is the generic name for the popular antacid medication, Zantac. Available in both over-the-counter (OTC) and prescription varieties, millions of people have taken Zantac since it was approved by the FDA. Some people have taken daily doses for many years, which is one of the concerns given the presence of a human carcinogen.
After being informed about the possible contamination, the FDA issued a statement to healthcare providers and patients about the possible risk. Several manufacturers responded by voluntarily recalling their ranitidine or Zantac products. Many retailers took matters in their own hands and removed all related products from their shelves without a formal Zantac recall. Wal-Mart, Walgreens, CVS and Rite-Aid were among the retailers that completely removed products after the initial recall.
Naturally, the antacid recalls and removals have caused concern among consumers who rely on the medication. Now they must find alternative treatment methods.
FDA Calls for Product Removal
In an FDA News Release in April 2020, the FDA requested that all manufacturers withdraw OTC and prescription varieties of Zantac and ranitidine from the market. The FDA has determined that NDMA levels in ranitidine products increase over time, especially when stored at temperatures higher than room temperature. As a result, consumers may suffer exposure to higher than acceptable levels of the substance.
The FDA notes that it is difficult to determine how long certain medications have been in storage, and where they are stored before distribution. Also, warehouses and distribution facilities may not maintain average room temperature, which can put the product at risk for increased contamination at any point during the distribution process.
The FDA further notes that the older a ranitidine product is, the greater the chance for significant increases in NDMA levels. This further raises the possibility that consumers taking the medication could be at an elevated risk for certain cancers.
Zantac Recall and Removal Long Overdue
Many people believe that the Zantac recall and removal from the market is long overdue. For decades, researchers have proven the link between NDMA and ranitidine. There are even decades-old lawsuits arguing that NDMA levels increase in the body after taking Zantac. These arguments have continued since the 1980’s.
Since the 1980’s, studies have found that when someone consumes ranitidine, it comes in contact with nitrites in the body and has the potential to form NDMA inside the body. Other studies suggest that NDMA could form in the body after drinking chlorine-treated water. Another study suggests a link between NDMA formation and pH levels inside the body. Studies have shown that study participants have excreted NDMA in urine at significantly increased levels.
Lawsuits against drug manufacturers argue that consumers were not properly warned about the possible danger of NDMA. Furthermore, despite research showing a link between NDMA and health complications, manufacturers continued to market the product as safe, without warning consumers about the presence of NDMA at all.
Does Zantac Cause Cancer?
The contaminant, NDMA, is classified by the World Health Organization (WHO) as a probable human carcinogen. In small doses, NDMA likely will not cause health complications. NDMA naturally occurs in the environment, and human exposure is extremely small.
However, prolonged exposure to NDMA, such as through medications, may increase the risk of certain types of cancer. Those types of cancer include:
Unfortunately, researchers do not yet know how significantly the risk of these cancers increases through NDMA exposure. Furthermore, current studies are inadequate to assess how NDMA exposure effects consumers over time. The FDA continues to investigate the link between NDMA, Zantac and cancer. For the time being, safety officials believe it is best to pull products from the market in an effort to prevent exposure.
Information for Consumers about Zantac Recall and Removal
If you regularly take Zantac or generic ranitidine, the FDA urges you to stop taking it immediately and dispose of any leftover medication. Due to COVID-19 concerns, the FDA asks consumers not to take medications to a drug take-back facility, but rather to dispose of them at home. Their recommendation for disposal includes:
The FDA also urges consumers to talk to their healthcare providers about alternatives to Zantac or ranitidine. There are many medications available to treat heartburn, indigestion or gastro esophageal reflux disease. The FDA notes that Nexium, Tagamet, Pepcid, Prevacid and Prilosec are all FDA-approved, and none of these medications have tested positive for NDMA. Your healthcare provider can certainly direct you on the best alternative to treat your symptoms.
If you take Zantac or ranitidine and experience adverse events, you can file a report with the FDA. When consumers file reports with the FDA, they are providing valuable information that helps the FDA focus their investigation. You can file a report through the MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Zantac and Your Legal Rights
If you take Zantac, or have previously, it is natural to be concerned about your health. It is also natural to consider your legal rights as they relate to the Zantac recall and removal. As a consumer, you trust that the products you buy are safe. When a manufacturer fails to disclose a hazard, you may feel that your trust is misplaced. You may also suffer harm or illness as a result of the hazard.
In these cases, it is more than reasonable to contact a medical malpractice attorney to discuss your legal rights. Numerous lawsuits are pending against drug manufacturers related to Zantac. Certainly, the best way to determine your legal rights and any possible legal action you qualify for is to work with a skilled attorney.
At MedMalFirm.com, we help clients with all types of medical malpractice. This includes medical mistakes, medication and pharmaceutical errors and defective products. To request a free consultation with one of our attorneys, call us toll free at 877-887-4850. You can also reach out to us online via the contact form on our website.