Since September 2019, Zantac and other ranitidine drugs have been undergoing investigation to determine if the levels of N-Nitrosodimethylamine (NDMA) in the medications are above the acceptable safety limit. After the U.S. Food and Drug Administration (FDA) announced NDMA was discovered in these drugs, retailers such as CVS, Rite Aid, Target, and Walmart have removed all prescription and over-the-counter (OTC) ranitidine drugs from their shelves. In October 2019, Sanofi, a pharmaceutical manufacturer, voluntarily recalled Zantac over-the-counter sold in the United States and Canada. During that time, Sanofi said it issued the recall “due to inconsistencies in preliminary test results.”
On April 1, 2020, the FDA announced that it is requesting that all ranitidine products, including Zantac, to be removed from the market immediately. This request for withdrawing Zantac and its generics from the market was determined necessary after laboratory tests found new results related to the effects of different storage scenarios for these products. Zantac and other ranitidine products will no longer be available for over-the-counter and prescription use in the United States.
FDA’s Earlier Findings
N-Nitrosodimethylamine (NDMA), the substance found in Zantac, is a probable human carcinogen and has the potential to cause cancer. Small amounts of NDMA are commonly digested in one’s normal diet as it is present in foods and water. On the other hand, highly regular and sustained levels of exposure to NDMA may increase the risk of cancer in humans.
During the FDA’s September 2019 testing, low levels of NDMA were found. At the time, the FDA was working with limited data and required more scientific evidence to determine the true dangers of Zantac. The agency could not confidently recommend whether patients should stop or continue taking Zantac and other ranitidine drugs. The risk of cancer from occasional usage of Zantac was not expected to be high, but the FDA warned the public to be aware of the potential health risks and to consider alternative products.
“We didn’t observe unacceptable levels of NDMA in many of the samples that we tested,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in Wednesday’s announcement.
New Test Results Show Increased NDMA Levels & Cancer Risk
Recent reports and tests from third-party laboratories and the FDA have brought to attention the effects of storage and time on NDMA levels in ranitidine drugs. It was found that NDMA levels will increase in the medications even when they are stored in normal conditions. This means that any Zantac that patients keep in their medicine cabinet at home could have increased levels of NDMA. The new tests also discovered that the NDMA will significantly increase when stored at higher temperatures. This includes the high temperatures the medications may be exposed to while they are being manufactured, distributed, and then handled by patients.
Not only will NDMA levels increase in regular storage and with high temperatures, but also with time. The tests also found that the older a ranitidine product is, the higher the level of NDMA it will have. All of these factors have the potential to raise NDMA levels in the ranitidine product to a dangerous limit above what is acceptable for daily intake.
“However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,” said Woodcock. “The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”
The FDA is planning to notify all manufacturers of ranitidine that they must remove their products from the market.
Recommendations From The FDA
All consumers should immediately stop using any type of over-the-counter ranitidine tablet or liquid in their possession and should no longer buy these medications. Ranitidine medications should be disposed of properly to avoid environmental harm. Those who need heartburn medication should consider using alternative over-the-counter drugs approved to treat their condition.
All patients who take prescription ranitidine drugs should consult their health care professional to determine the best alternative treatment options before they completely stop taking the medication. The FDA notes that there are many other medications that are approved for similar uses as ranitidine and do not have a risk of cancer from NDMA exposure. These drugs include:
- Cimetidine (Tagamet)
- Esomeprazole (Nexium)
- Famotidine (Pepcid)
- Lansoprazole (Prevacid)
- Omeprazole (Prilosec)
The FDA is recommending consumers and patients to not visit a drug take-back location, due to the dangers and necessary precautions for the current coronavirus (COVID-19) pandemic. Instead, consumers and patients should follow the specific disposal instructions in the medication guide or follow the agency’s online steps on how to dispose of the medications at home safely.
More Zantac Plaintiffs Will Emerge
This Zantac removal announcement will encourage more patients and consumers to seek legal action against drug manufacturers such as Sanofi-Aventis and Boehringer Ingelheim Pharmaceuticals. Claims against these negligent pharmaceutical companies will be based on the fact that these companies knew or should have known that their ranitidine products were dangerous and may cause cancer from NDMA exposure. Patients who were diagnosed with cancer and have been taking Zantac or other ranitidine drugs, over-the-counter or prescription, for at least 12 months will be eligible to file a Zantac Lawsuit.
Connect With Qualified Zantac Plaintiffs
Broughton Partners helps personal injury attorneys connect with signed Zantac lawsuit plaintiffs who are seeking legal representation. Our in-house experts ensure that these qualified retainers are the correct fit for your firm before connecting them to your firm.
Contact us today at (855) 463-1735 for your free consultation.