Recently, multiple ranitidine and Zantac manufacturers recalled their products due to concerns that they contain high levels of NDMA, a likely carcinogen.
On April 1, 2020, the FDA requested that all Ranitidine (Zantac) products be removed from the market.
If you or a loved one were diagnosed with bladder, colon, kidney, rectal, stomach, and another cancer after taking Zantac, contact the Zantac Recall Lawsuit Lawyers today for a free case review.
Zantac (ranitidine), the popular over-the-counter heartburn medication, has recently been at the center of several newly filed lawsuits because of concerns about contamination with a cancer-causing chemical. Recently, two class-action lawsuits were filed against Zantac manufacturer Sanofi-Aventis LLC and Boehringer Ingelheim Pharmaceuticals, who previously held rights to Zantac, with plaintiffs claiming that the companies knowingly put patient health at risk.
Zantac, the most popular brand of ranitidine, is used to help reduce stomach acid. The medication is commonly prescribed to treat ulcers, gastroesophageal reflux disease (GERD), chronic indigestion, and Zollinger-Ellison syndrome. It comes in both over-the-counter and prescription strengths that may be taken by mouth or administered via injection into a muscle or vein.
Ranitidine belongs to a class of drugs known as H2 blockers that work by reducing the amount of acid the stomach produces. H2 receptors are present on the cells in the stomach lining. A histamine chemical normally stimulates these receptors to produce acid to the body help digest food. Ranitidine blocks these receptors, and prevents histamine from producing its normal effect, which causes the stomach to produce less acid.
N-nitrosodimethylamine (NDMA) is a probable carcinogen. It is an industrial waste product, yellowish in appearance with a faint, distinctive odor. Found in cured meats and tobacco smoke, it is a common environmental contaminant. This substance has also been used as a stabilizer in industrial lubricants as well as an ingredient in rocket and jet fuel.
NDMA may also be formed as a by-product of other manufacturing processes. According to the Centers for Disease Control and Prevention (CDC), humans can be exposed to NDMA through a wide variety of sources, including:
NDMA can even form in the stomach during digestion of alkylamine-containing foods and has been detected in small amounts in breast milk. In addition to WHO and IARC, NDMA has been classified by the Environmental Protection Agency (EPA) as probably carcinogenic to humans, because it can modify DNA. Studies have shown the chemical to increase cancer risk in animal experiments.
According to a toxicology review from the World Health Organization, NDMA induces cancer through a process known as biotransformation, interacting with a certain enzyme in the liver. This causes DNA mutation, which is known to be a precursor to the formation of malignant tumors.
As of October 2019, neither the FDA or drug manufacturers had received any adverse event reports associated with NDMA in ranitidine. A class action lawsuit filed in San Francisco in September claims that defendants Sanofi and Boehringer Ingelheim were aware of the danger and failed to warn patients. More recently, a Zantac lawsuit was filed in Florida by a plaintiff who claims his prostate cancer was the result of taking Zantac over a seven-year period.
Types of injuries associated with Zantac and generic forms of ranitidine may include:
Some plaintiffs have already filed lawsuits against the makers of Zantac and of generic ranitidine, and more are expected to be filed in the future. In September 2019, for example, five plaintiffs joined together to file a class-action lawsuit against Zantac manufacturer Sanoti-Aventis LLC and former owner of the rights to Zantac, Boehringer Ingelheim, which manufactured and distributed the drug between October 2006 and January 2017.
The plaintiffs claimed that the defendants failed to warn healthcare providers and the public about the dangers of taking Zantac, and did not reveal that Zantac could produce NDMA in the human body.
If you or a loved one took Zantac or generic ranitidine and suffered a serious cancer injury, you may be eligible to file a Zantac lawsuit to recover damages. Shamis & Gentile, P.A. is now investigating these cases and invites you to call today at 305-479-2299 or fill out a form here and our team of Zantac Recall Lawsuit Lawyers will review your information and will be in contact.
If you or one of your loved ones have received a cancer diagnosis in connection with your use of Zantac, you could qualify to file a Zantac cancer lawsuit against the manufacturer of the drug.
In April 2020, the Food and Drug Administration (FDA) ordered all wholesalers and retailers to stop selling the heartburn medication, Zantac. It also urged consumers to cease using any Zantac they may already have in their homes and throw it away immediately. The announcement came after the FDA announced its findings in September 2019 that the medication contains a carcinogen called N-nitrosodimethylamine, or NDMA – or, at least, has a tendency to form NDMA as a result of the chemical breakdown of the product during long periods of storage.
NDMA has the ability to alter the structure of human DNA. If it is consumed at levels beyond the recommended daily intake of .096 micrograms per day, this contaminant has been shown to put consumers at considerable risk of contracting cancer. After testing ranitidine, the active ingredient in Zantac, the FDA published results indicating that the medication contains NDMA levels ranging from .01 to.36, placing the users of the product at very high risk of developing cancer.
It is uncertain at this stage whether the formulation of Zantac is faulty or if NDMA seeps into the drug during the manufacturing process. Zantac is one of several commonly used, over-the-counter medications found to have unacceptably high quantities of the chemical. It has been suggested, in an article published in Scientific American, that such contamination may result from side reactions during the synthesis of certain drugs, the manner in which unstable drug compounds break down, and contamination from recycled manufacturing solvents.
There are large-scale research efforts currently underway to determine exactly how NDMA has been allowed to reach such unacceptable levels in these common medications.
Short- and medium-term exposures ranging from five days to 12 weeks are associated with liver damage in several different species. In other animal studies, the drug has been linked to gastrointestinal hemorrhage and harmful effects in the kidneys, lungs, spleen, and myocardium following several weeks of administration. Rodent studies also demonstrate a consistent carcinogenic effect of NDMA. The effects of lifetime exposure to NDMA in rats’ drinking water were described in a dose-response study, in which the incidence of liver tumors was increased and survival rates decreased, in a dose-dependent manner. In humans, overexposure to NDMA has been linked to a variety of symptoms, including nausea, vomiting, abdominal cramps and diarrhea, headache, fever, enlarged liver, and jaundice. Sustained exposure to levels higher than the .096 recommendation has been linked to severe liver damage. Other potential symptoms of overexposure include headache, fever, nausea, vomiting, abdominal cramps, enlarged liver, dizziness, and reduced function of the liver, kidneys and lungs.