FDA Requests Removal of All Ranitidine Products (Zantac) from the Market
- FDA Advises Consumers, Patients and Health Care Professionals After New FDA Studies Show Risk to Public Health
On September 13, 2019, the U.S. Food and Drug Administration (FDA) reported that they had discovered a cancer-causing chemical N-nitrosodimethylamine (NDMA) in brand-name Zantac (ranitidine) and generic heartburn medications.
Doctors and health care providers have prescribed Zantac more than 15 million times a year, which has been available for decades.
Although NDMA can cause harm in large amounts, the levels the FDA is finding in Zantac is extremely low, barely exceeding the amounts you would find in common foods. That said, NDMA has been linked to a number of cancers, including:
If you or someone you love took Zantac or a generic version of the drug for a year or more and has since developed one of the cancers listed above, you may be eligible to participate in the lawsuit against the drug manufacturer. To find out whether you are eligible to participate in the litigation, contact Cordisco & Saile LLC at (215) 642-2335.
What We Know About NDMA
The ranitidine molecule, the key ingredient in Zantac and other generic versions of the drug, reacts to nitrates and forms carcinogens like NDMA.
NDMA is a contaminant that can form naturally or through chemical processes. It is found in various sources, including water, smoked or cured fish and meats, shampoo and other cosmetic products, and cigarette smoke.
This is not the first time a drug has been recalled because NDMA was detected. In 2018, the FDA recalled different drugs that contained valsartan, an ingredient used to treat heart failure and high blood pressure.
A 2015 analysis of 49 studies found that a high dietary level of NDMA consumption increased the likelihood of developing gastric cancer. Researchers discovered that people who had a high intake of NDMA were approximately 34% more likely to develop this type of cancer. Another study, published in 2019, found NDMA was associated with an increased risk of pancreatic cancer.
NDMA and Zantac Complications and Symptoms
In addition to potentially causing cancer, NDMA is a hepatotoxin. Exposure to high levels of NDMA may cause:
- Liver damage
- Reduced liver, kidney, and lung function
- Abdominal cramps
- Enlarged liver
Animal studies that tested exposure of NDMA in various species, including mice and rats, found that it caused tumors of the liver, respiratory tract, blood vessels, and kidneys.
Some symptoms that have also been associated with taking Zantac include
- Risk of pneumonia
- Liver failure
- Vitamin B-12 deficiency
- Nervous system disorders
- Irregular or rapid heartbeat
For a free review of your case, call Cordisco & Saile LLC at (215) 642-2335 today.
Should You Stop Taking Zantac
You should always talk to your physician before stopping or starting any medication. It is also important to note that the FDA has not currently called for the public to stop taking Zantac or other ranitidine products.
From a statement release by the FDA on September 13, 2019, the FDA did not recommend that people stop taking ranitidine, but rather, the FDA suggested that people talk to their doctor first about treatment options if they wanted to stop taking the drug. The FDA also suggested talking to your doctor about using other over-the-counter drugs that would provide the same or similar effects as ranitidine.
That said, the drug was intended as a short-term heartburn solution, and patients should not be taking it longer than the package recommends. If you are concerned, you should speak with your doctor to find other treatment options for relieving heartburn.
Manufacturer’s Knowledge of the Risks
Ranitidine has been studied since its release in the 1980s. The product was approved in 1984 and used worldwide since. The warning about probable contaminants came after Valisure, an online pharmacy and laboratory, discovered NDMA in several different forms of the drug. The company reports that evidence of the potential risks associated with the drug can be traced to studies published since the 1980s.
In fact, Valisure said that Zantac’s originator, Glaxo Research Group, conducted a study in 1987 after a number of other studies had issues about the safety of ranitidine. While the study found no significant increase in NDMA within 24 hours of taking Zantac, Valisure CEO David Light said that the study’s testing methods were less accurate and that the researchers involved in the study discarded stomach samples that contained ranitidine.
Recoverable Damages in Zantac Lawsuits
If you took Zantac and have received a diagnosis of cancer and other complications linked to NDMA, you may be entitled to compensation for your damages. Some damages sought for victims include:
- Past and future medical expenses associated with your injuries
- Past and future lost wages as a result of time away from work or lost earning potential
- Pain and suffering caused by the illnesses, treatment, and recovery process
- Loss of enjoyment of life
- Punitive damages, if appropriate
A Zantac Lawyer in Bucks County Can Help
As you can see from the studies that go back as far as the 1980s, the pharmaceutical company either knew or should have known about the link between Zantac and cancer. They failed to sufficiently study the medication and research the possible side effects that could come from prolonged exposure. They also failed to warn physicians or patients about possible complications associated with taking the drug.
Because of the widespread use of this drug since its introduction in the 80s, many people may have possible claims.
A Zantac lawyer can examine your case and determine whether you are eligible to participate in the lawsuit against the manufacturer. For a free, no-risk review of your case, contact Cordisco & Saile LLC at (215) 642-2335.