What is Zantac?The U.S. Food and Drug Administration (FDA) announced on September 13, 2019, that low levels of N-nitrosodimethylamine (NDMA) were detected in Zantac. NDMA is a carcinogen, and was found in many drugs over the past few years. Most recently, high levels of NDMA were found in a diabetes drug, Metformin, leading to a recall in October 2020. Patients regularly took ranitidine, often referred to by its brand name, Zantac, to relieve and prevent heartburn. Zantac was available both over the counter and by prescription. Heartburn patients used over the counter strength Zantac, typically in 150-milligram tablets. However, prescription strength Zantac treated and prevented serious ulcers in the stomach and intestines, and doctors typically prescribed 300 milligrams of Zantac per night for four to eight weeks. The most common Zantac products that contained ranitidine included:
- Zantac 150 Tablets
- Zantac 150 Maximum Strength
- Zantac 150 Maximum Strength Cool Mint
- Zantac 75 Tablets
- Wal-Zan 150
- Wal-Zan 75
- Heartburn Relief
- Acid Reducer
- Acid Control.
Zantac, Side Effects and CancerIf you or a loved one has suffered from the negative side effects of Zantac containing NDMA, you may want to pursue a claim. Additionally, stop taking Zantac and speak to a doctor about alternative medications you can use to help ease your condition. If you feel any of the following symptoms while taking Zantac, consult a medical professional, as these are common cancer symptoms:
- Unintentional weight loss
- Poor appetite
- Nausea or vomiting
- Bloody or tarry stools
- Light-colored or greasy stools
- A change in bowel habitats
- Symptoms of anemia such as fatigue, dizziness, and weakness
- New abdominal pain unrelated to heartburn
- Back pain
- Yellowing of the skin or eyes
- Dark urine
- Blood in the urine
- Urinary urgency or incontinence
- Painful urination
- Itchy skin.
- The individual took Zantac and developed cancer afterwards due to the NDMA contained within the medication
- The individual took Zantac and was unaware of the risks posed by the medication.
- Medical expenses from your injuries
- Future medical expenses resulting from the injuries
- Pain and suffering caused by the injuries, treatment, and recovery
- Loss of income
- Loss of life
- Punitive damages against the manufacturer.
The Zantac Recall and NDMANMDA can form through industrial processes, such as the chlorination of wastewater or drinking water. However, NDMA can also form through a natural process. The active ingredient in Zantac, ranitidine, contains nitrite (“N”) and dimethylamine (“D”), which are two elements required to form NDMA. The presence of nitrite and dimethylamine in ranitidine makes Zantac vulnerable to creating NDMA when patients take it. While people may consume low levels of NDMA in their everyday diets, high levels can expose humans to an increased risk of cancer. Valisure Online Pharmacy recently conducted an independent study to investigate how Zantac produced NDMA. Valisure imitated the conditions that the human stomach exposes Zantac to once patients take it. This study found that Zantac produces an alarming amount of about 304,500 nanograms (ng) of NDMA, which is much higher than the FDA-approved acceptable amount of NDMA of 96 ng per day, when exposed to the gastric fluid and sodium nitrites in the stomach. Other studies have also found that a Zantac user typically has a “400-fold increase of NDMA concentration in their urine.”
Risks of NDMA Exposure Through Ingestion of ZantacNDMA is classified as a B2 carcinogen by the EPA, which means that it is a “probable human carcinogen.” Since human studies are limited, multiple NDMA studies were run on rats and mice. From these studies, the researchers found that the animals developed tumors in their livers, respiratory tracts, and blood vessels after NDMA exposure. This study is significant since it is believed that NDMA is a probable carcinogen to both humans and animals. Thus, the U.S. Department of Health and Human Services has reasonably anticipated that NDMA is a human carcinogen. NDMA exposure can lead to prostate cancer, leukemia, multiple myeloma, colon cancer, stomach cancer, intestinal cancer, pancreatic cancer, lower esophageal cancer, or non-Hodgkin's lymphoma. In addition, anecdotal evidence links Zantac to breast cancer. A 2008 study found “that ranitidine and Zantac increased the risk of ductal carcinoma by more than two-fold.” The increased risk of ductal carcinoma, the most common type of breast cancer in the United States, occurred in both men and women. Additionally, lawsuits have alleged that Zantac causes breast cancer. Further research has also found that even small amounts of NDMA can lead to liver damage. Additional symptoms of NDMA exposure include fever, headaches, abdominal cramps, jaundice, vomiting, nausea, dizziness, and reduced functioning of the liver, kidneys, and lungs.
Initial Investigations and the Zantac RecallThe FDA first knew that an independent laboratory found NDMA in Zantac during summer 2019. Following this, the FDA conducted its own laboratory tests and found low levels of NDMA in Zantac. However, this did not provide enough scientific evidence for the FDA to recommend that people should not continue to take Zantac. Instead, the FDA chose to continue its investigation. Instead of halting distribution, the FDA only suggested that the public consider alternative over the counter treatments and prescription medications. While the FDA continued its investigations, Canada, France, Germany, Italy, and Switzerland immediately halted the distribution of drugs containing ranitidine. Following the FDA's recommendations, numerous pharmaceutical companies, including Sandoz Inc., Apotex Corp., Dr. Reddy's Laboratories Ltd, and Sanofi-Aventis US LLC, began voluntarily recalling Zantac products. Throughout fall 2019, multiple retailers, including Walmart, CVS, and Rite Aid stopped selling Zantac, and CVS even offered refunds to customers who had recently purchased Zantac or other ranitidine drugs. In January 2020, the FDA also revealed that Appco Pharma LLC and Northwind Pharmaceuticals voluntarily recalled their prescription ranitidine medications. The FDA continued to investigate the link between Zantac and NDMA and confirmed that the NDMA levels did increase in Zantac, even under normal storage conditions. When Zantac samples were stored at higher temperatures, the NDMA levels significantly increased. Distribution and customer handling increased the chances of exposing Zantac to higher temperatures. FDA testing and evaluation further found that older Zantac products contained greater levels of NDMA. Unfortunately, it is almost impossible to know whether the Zantac you purchased from a retailer was stored at room temperature or in a warehouse with high temperatures, or whether the drug was on the shelf for months or whether it was stocked in the past few days.
The FDA's Press Release and Following Zantac RecallOn April 1, 2020, the FDA sent out letters to ranitidine manufacturers and requested that they withdraw their products from the consumer market. As of April 1, 2020, the FDA has officially advised consumers to stop taking any over the counter Zantac medications and to not buy any more. The FDA recommended that individuals who wish to treat heartburn symptoms take other approved over the counter medications. Following the FDA's news release, manufacturers of Zantac, including Teva Pharmaceutical Industries Ltd., Mylan Inc., and Novartis AG, immediately withdrew their products from the market. In June 2020, the U.S. Department of Justice and the U.S. Attorney's Office for the Eastern District of Pennsylvania gave notice of their investigation into Sanofi and GlaxoSmithKline LLC. As of August 2020, the U.S. Department of Justice was still investigating the two pharmaceutical companies over the cancer-causing effects of Zantac. Sanofi's half-year financial report noted that the inquiry will investigate claims that the pharmaceutical manufacturer violated the False Claims Act, 31 U.S.C. § 3729, by failing to disclose the presence of NDMA in Zantac. Sanofi's half-year report also notes that the New Mexico Attorney General filed a complaint against Sanofi in June 2020, alleging that the company violated the New Mexico Unfair Practices Act, the New Mexico False Advertising Act, the New Mexico Public Nuisance Act, and committed common law public nuisance and negligence. In addition to the lawsuits Sanofi faces in the U.S., the company is also confronting lawsuits in Canada, in both the British Columbia Supreme Court and the Ontario Superior Court. GlaxoSmithKline LLC also discussed the DOJ's investigation in its second-quarter 2020 earnings filing, and noted that they are cooperating with the DOJ's request for their records and information. GlaxoSmithKline LLC is also a defendant in the New Mexico Attorney General's lawsuit.
Zantac LitigationAs of February 6, 2020, a multidistrict litigation (MDL) lawsuit against the manufacturers of Zantac joined 15 separate actions. The MDL was brought in the U.S. District Court for the Southern District of Florida. Of the 15 claims, nine are personal injury claims, whereas the remaining six are “brought on behalf of putative classes of consumers seeking refunds and other economic damages stemming from their purchases of Zantac.” In addition to these 15 actions, 126 related actions are pending in 21 different districts. The court allowed the centralized proceedings to proceed, and to include “both the related personal injury actions, in which plaintiffs allege that they developed cancer as a result of NDMA formed from Zantac, and the related consumer MDL, in which plaintiffs allege that they suffered economic losses as a result of defendant's alleged concealment of the NDMA-associated dangers posed by Zantac.” The plaintiffs in these lawsuits claim that the distributors of Zantac, including Sanofi, Boehringer Ingleham, and other defendants, knew about the dangers of NDMA and its presence in Zantac, but failed to properly warn the public. Plaintiffs claim that if they knew that Zantac contained NDMA, they would have never used the medication. As of September 16, 2020, the Zantac litigation was still in early discovery stages and the litigation will continue to progress as we move into 2021.
Seek an Experienced Zantac Lawsuit AttorneyIf you or a loved one have regularly used Zantac or ranitidine medications and have developed one of the aforementioned cancers then do not hesitate to contact Dolman Law Group Accident Injury Lawyers, PA about the possibility of seeking compensation for damages you may have suffered. Dolman Law Group Accident Injury Lawyers, PA offers free consultations to those who believe their cancer is linked to Zantac use. You do not have to suffer through your illness lying down while those that may be responsible count their dollars. If your injuries can be connected to the use of Zantac then you may be able to file a defective medication lawsuit against Sanofi to get the compensation you not only need but deserve as well. Our attorneys are ready to speak with you about what they can do to help get you that compensation and what legal options may be available to you depending on the details of your case. Dolman Law Group Accident Injury Lawyers, PA specializes in holding these groups accountable for their negligence and recovering settlements for those that have suffered because of this negligence. Dolman Law Group Accident Injury Lawyers, PA has served the people of Florida for years by providing award-winning legal representation that has earned us a long history of successful cases both settled out of court and hard-won at trial. Contact us today to get the compensation you deserve from a Zantac Lawsuit. You can reach our office by either calling (833) 606-DRUG  or fill out a contact form online
Dolman Law Group Accident Injury Lawyers, PA 800 N Belcher Rd Clearwater, FL 33765 (727) 451-6900 https://www.dolmanlaw.com/zantac-injury-compensation/