Zantac Injury Lawsuit

What is Zantac?

Zantac is the trade name for Ranitidine, a popular medication that reduces the body’s production of stomach acid. The medication is commonly used to treat and prevent ulcers of the stomach and intestines as well as gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, peptic ulcer disease, acid indigestion, and heartburn.

Ranitidine belongs to H2 (histamine-2) blockers class of drugs. OTC Zantac is most commonly used to relieve and prevent heartburn, while the prescription-strength drug is used to prevent more serious ulcers and conditions. The drug came into commercial use in 1981 and is now the 50th most-prescribed medication in the United States. 

Zantac Lawsuits

However, the makers of Zantac, are facing a numerous lawsuits claiming the drug contains unsafe levels of the cancer-causing substance N-Nitrosodimethylamine (NDMA).

Ranitidine was approved for mass markets in 1984. Researchers at Valisure said the drug’s potential risks were discovered in medical studies close to its inception. Valisure’s CEO, David Light, said the risk appears to be in the drug itself, instead of the manufacturing byproduct, and that the problem has been there since the 1980s. In a petition to the FDA, Valisure cited the 1987 study on the concerns of Ranitidine conducted by Glaxo Research Group, Zantac’s original research group which had alleged less accurate testing methods.

On 13th of September, 2019, the U.S. Food and Drug Administration (FDA) released a statement asserting the presence of carcinogenic contaminant, NDMA in Ranitidine, the active ingredient in Zantac, at levels between 3,000 to 26,000 times higher than FDA approved standards. In the past few weeks preceding the statement release, there have been generic Ranitidine drugs recalls from pharmacy shelves across the U.S amid growing concerns. 

Zantac FDA Warning

The FDA acceptable threshold of daily NDMA intake is earmarked below 100 nanograms. The plaintiffs cited a study that claims that a 150-milligram pill of Zantac contains over 2.5 million nanograms of NDMA. Over the counter, Zantac is typically sold in 150-milligram tablets; the recommended dosage to treat peptic ulcer disease for adults is 300 milligrams a night for four to eight weeks.

Several published studies have shown that Zantac users have a 400-fold increase of NDMA concentration in their urine. The suit attests that had consumers known the risks, they would not have purchased or consumed Ranitidine.

Zantac Cancer Risk

Zantac has been routinely used by heartburn sufferers for decades, leading consumers to question how the drug became a potential carcinogen. Zantac was prescribed more than 15 million times yearly without safety concerns prior to the FDA’s announcement. The FDA initially found no NDMA in other alternatives such as Pepcid, Tagamet, Nexium, Prevacid, and Prilosec.

The World Health Organization described NDMA as a chemical that is “clearly carcinogenic.” It is a potential hepatotoxic, and exposure has been linked to numerous complications and symptoms ranging from bladder cancer, stomach cancer, liver fibrosis and scarring, and tumors in the liver, kidneys, and lungs. Other symptoms of NDMA exposure include headaches, fever, nausea, jaundice, vomiting, abdominal cramps, dizziness, and reduced function of the liver, kidneys, and lungs.

The FDA is working alongside regulators and industry partners to discover the source of impurities in Ranitidine. Many chemists believe that Ranitidine is reacting with something else during manufacturing, finishing, or in storage. The Agency also asked pharmaceutical companies to examine if the drug’s ingredients are exposed to nitrites during manufacturing.

The FDA suggests patients who wish to discontinue prescription or regular use talk to their health care professional about alternative treatment options. 

Filing a Zantac Lawsuit Claim

If you took Zantac and have been diagnosed with health complications, we will work to seek the following damages for you:

• Medical expenses resulting from injuries.

• Pain and suffering, both physical and mental, caused by the injuries, treatment, and recovery period.

• Wage loss, loss of earning capacity.

• Loss of enjoyment of life resulting from damages.

• Punitive Damages.

A lawsuit can help protect the rights of those adversely affected by Ranitidine. If successful, it can help the victims recover the money spent on the Zantac medication while making a stronger litigation case against manufacturers. This can help ensure stronger future consumer protections, updated labeling, and recalls of drugs with hazardous levels of NDMA.

The Current situation

The FDA studied how Ranitidine reaction with stomach and intestine fluids and found no evidence that Zantac formed carcinogens. However, Valisure, an independent online laboratory, and pharmacy tested Zantac in stomach-like fluids with added nitrates commonly found in the body and in foods. With nitrates added, Valisure found one tablet of Zantac exceeded the FDA’s NDMA threshold 3,100 times.

Following the Agency’s announcement, many retailers and drugmakers took action. Health Canada stopped distributing the drug, Sanofi, a French drugmaker, recalled the drug from retail shelves and drugstores. Germany, Italy, and Switzerland did the same. Taiwan instituted a fine for any pharmacy with Ranitidine on its shelves, and Pakistan banned the drug’s distribution and manufacturing.

Despite the voluntary recalls, the FDA took a more measured approach, asking manufacturers to recall the drugs if NDMA exceeds standards after testing. There have been Zantac recalls and generic Ranitidine recalls from various companies.

Pennsylvania & New Jersey Unsafe Drug and Medical Device Attorneys

If you or anyone you know has suffered health problems, especially kidney disease, as a result of heartburn or acid reflux medication, please contact our attorneys immediately to discuss your legal rights toll-free at 215-462-3330 or via our online contact form.