The US Food and Drug Administration announced Wednesday that it is requesting manufacturers pull all prescription and over-the-counter ranitidine drugs, known by the brand name Zantac, from the market immediately.
The FDA noted that an ongoing investigation has determined that levels of a contaminant in the heartburn medications increase over time and when stored at higher-than-normal temperatures, poses a risk to public health.
The contaminant, N-nitrosodimethylamine or NDMA, is a probable human carcinogen and the FDA has been investigating levels of it in ranitidine since the summer of 2019.
The director of the FDA’s Center for Drug Evaluation and Research, Dr. Janet Woodcock, made the following announcement today:
We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. 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. 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.
According to the FDA’s announcement, letters are now being sent to all manufacturers of ranitidine requesting that they withdraw products from the market, and consumers are advised to stop taking any ranitidine tablets or liquid medications they currently have.
The FDA said to dispose of them properly and not buy more.
Due to the coronavirus pandemic, the FDA said don’t return your medicines to a “drug take-back location,” but rather follow disposal instructions in the medication guide or follow the FDA’s recommended safe disposal steps on its website.
The FDA urges consumers who wish to continue treating their condition to consider using other approved medications.
To date, the FDA has not found NDMA in some other products, such as famotidine or Pepcid, esomeprazole or Nexium, or omeprazole or Prilosec.
For patients taking prescription ranitidine, the FDA recommends speaking to your doctor about other treatment options before stopping the medicine.
“There are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA,” according to the FDA.
In September, CVS Pharmacy, Walgreens and Walmart all announced they would no longer sell Zantac and other over-the-counter ranitidine medications due to concerns they might contain NDMA.
Then in October, drugmaker Sanofi voluntarily recalled Zantac OTC sold in the United States and Canada. At the time, the company said it issued the recall “due to inconsistencies in preliminary test results.”
You should be able to trust that the medicines you purchase over the counter or through a prescription are safe when used as directed. Sadly, this is not always the case and when medications are deemed unsafe, the manufacturers of the drugs may be held liable for injuries caused by the medication. Our Florida Defective Drugs and Devices Class Action Attorneys at Whittel & Melton are committed to helping consumers who were harmed by dangerous drugs hold pharmaceutical companies accountable for their negligence. If you or your loved one has been diagnosed with cancer after regularly using over-the-counter Zantac or prescription Zantac, you may have a right to file a Zantac cancer lawsuit or join a Zantac class action lawsuit.
Our Zantac Lawsuit Attorneys at Whittel & Melton are currently reviewing potential legal claims involving Zantac. There are already several Zantac class action lawsuits underway that allege the manufacturers of Zantac, a pharmaceutical company Sanofi, were aware of the cancer risks associated with ranitidine, but failed to warn consumers of the risk. We are expecting many more claims to be filed.
What is Ranitidine?
Ranitidine is an over-the-counter and prescription drug better known by the brand name Zantac. Millions of Americans have used ranitidine as it is approved in over-the-counter medications to relieve heartburn related to acid indigestion and sour stomach. The medication is part of a class of drugs that decrease the amount of acid created by the stomach.
As this article shows, the FDA has confirmed that the brand name drug Zantac contains impurities that may cause cancer in humans. The impurity is called N-nitrosodimethylamine (NDMA), which can cause cancer after exposure to high doses of the compound over a long time period.
The following are a list of side effects of ranitidine:
- Stomach pain
- Itchy skin
- Liver damage
- Exposure to high levels of probable carcinogen
NDMA poisoning can cause stomach cramps, nausea and vomiting. It can affect the following organs:
Legal Liability for Zantac Drug Injuries and Illnesses
Drug makers have a legal duty to produce and market drugs that are safe and effective when used as directed. Manufacturers are required to warn the public of any known or potential risks associated with the products.