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Raleigh Zantac Lawyers

Ranitidine contains NDMA

Some widely used antacids and heartburn medications have been recalled because they contain unacceptably high levels of a probable carcinogen. Have you been diagnosed with cancer of the bladder, colon, stomach, kidney, testes or rectum after taking Zantac? You may be entitled to claim compensation from the manufacturer. Contact a knowledgeable drug injury lawyer for a free case review.

Hardison & Cochran is representing people in Zantac cancer lawsuits. People should be able to trust that the medicines they take are safe when used as directed. When the medicines have critical defects and are unsafe, the manufacturers may be held liable for injuries caused by the medication. Our attorneys are committed to helping injured consumers hold pharmaceutical companies accountable for dangerous drugs. If you or your loved one has been diagnosed with cancer and you regularly took 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.

At Hardison & Cochran, we are reviewing potential legal claims involving Zantac. Several Zantac class action lawsuits are underway, alleging that the manufacturers knew about the cancer risks associated with ranitidine, but failed to warn consumers of the risk. We expect many more claims to be filed. We consider it a privilege to use our legal skills to serve people who turn to us for legal assistance. Call to find out how we can help.

What is Ranitidine?

Ranitidine is an over-the-counter and prescription drug known by the brand name Zantac. It is used by millions of Americans. Ranitidine 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.

Prescription strength versions of Ranitidine are approved for multiple uses including treatment and prevention of ulcers in the stomach and the intestines, and treatment of gastroesophageal acid reflux disease (GERD), which can cause heartburn and injury to the windpipe.

Zantac was initially developed by Glaxo and approved for prescription use by the FDA in 1983. It became the best-selling drug in history and remains one of the top 10 antacid tablets. It was allowed for over-the-counter use in 1996.

The pharmaceutical company Sanofi-Aventis U.S. has held the rights to sell over-the-counter Zantac in the United States since 2017. Another company, Boehringer Ingelheim Pharmaceuticals, Inc., manufactured and distributed over-the-counter Zantac from 2006 to 2017.

Multiple companies sell generic versions of over-the-counter and prescription ranitidine.

FDA Recall of Ranitidine

In September 2019, the U.S. Food and Drug Administration warned that some medicines commonly known by the brand name drug Zantac contain impurities that may cause cancer in humans.

The impurity is called N-nitrosodimethylamine (NDMA). A known environmental contaminant, NDMA is classified as a probable cause of cancer in humans based on the results of laboratory results. NDMA may cause cancer after exposure to high doses of the compound over a long time period. NDMA is also found in some foods such as grilled meats, dairy products and vegetables.

The FDA announcement came after Connecticut-based online pharmacy and laboratory Valisure informed the FDA that its testing had detected extremely high levels of NDMA in multiple ranitidine products. Valisure said that indications of the drug’s potential risk can be found in multiple medical studies published since the 1980s. For example, researchers at Sanford University did urine tests of 10 people who took a 150-milligram tablet of Zantac and found NDMA levels higher than the FDA’s daily limits.

The FDA said Valisure’s testing methods may have raised the levels of NDMA in ranitidine test samples. The FDA’s own testing detected low levels of NDMA in ranitidine products that nonetheless exceeded the FDA’s daily threshold limits. The FDA is working with international regulators and pharmaceutical companies to try to determine the source of the impurity in ranitidine and assess the risk.

Recently, researchers at Emery Pharma, a California laboratory, reported that their testing indicated NDMA is being formed by the drug ranitidine itself as a result of the heating of the medication. For example, prolonged exposure to heat during the shipping of the drug to stores, or leaving Zantac in a car in the summer, is going to generate NDMA, the researchers said.

The FDA has asked all drug companies that produce ranitidine to test the products for NDMA. The FDA has advised the drug companies to recall their ranitidine medications if lab results showed the levels of NDMA above the daily intake limits. Many manufacturers have issued voluntary recalls of ranitidine medications.

Sanofi announced in October 2019 a voluntary recall of all Zantac over-the-counter products Including Zantac 150®, Zantac 150® Cool Mint, and Zantac 75®. Sanofi told CBS News in January 2020 that testing of its brand name Zantac is ongoing, and its voluntary recall of the product remains in effect.

Dr. Reddy’s Laboratories issued a nationwide recall in October of its 75 mg, 150 mg and 300 mg ranitidine medications that were sold at a number of major retail chains.

Apotex Corp., which manufactured ranitidine tablets sold at Walmart and Walgreens, has recalled the drugs. Walmart, the nation’s largest retailer, Walgreens, and CVS, the largest pharmacy chain, announced that they were suspending the sale of Zantac until further notice.

The FDA said that patients who are taking Zantac or generic equivalents may want to discuss with their doctor whether to continue or switch to another medication.

Ranitidine Side Effects

The side effects of ranitidine include:

  • Constipation
  • Diarrhea
  • Nausea
  • Vomiting
  • Stomach pain
  • Itchy skins, rashes
  • Pneumonia
  • Liver damage
  • Exposure to unacceptable levels of probable carcinogen

The organs potentially affected by NDMA include:

  • Bladder
  • Kidneys
  • Liver
  • Lungs
  • Pancreas
  • Stomach.

NDMA poisoning can cause stomach cramps, nausea and vomiting.

Who is Liable for Zantac Drug Injuries?

Drug makers have a legal obligation to produce and market drugs that are safe and effective when used as directed. Manufacturers are required to warn adequately of any known or foreseeable risks associated with the products.

When drug makers release unsafe products or fail to warn adequately of potential cancer risks or other harmful side effects, the manufacturers may be legally liable when consumers are harmed.

Despite scientific studies linking ranitidine to the production of unacceptable levels of NDMA, neither Sanofi-Aventis U.S. nor Boehringer Ingelheim Pharmaceuticals, Inc., during the years it had the rights to manufacture and distribute over-the-counter Zantac, has not included any warnings about the NDMA cancer risks on the drug’s label.

How Can a Raleigh Zantac Lawyer Help?

If you or your family member has received a cancer diagnosis and you suspect Zantac was the cause, you won’t know what really happened without the help of a knowledgeable attorney who investigates unsafe drug injury claims.

The first step is to contact a knowledgeable Zantac attorney at Hardison & Cochran as soon as possible to review the situation. You want to work with a reputable law firm that has the resources to pursue these complicated product liability cases against drug manufacturers.

Hardison & Cochran, Attorneys at Law has been in business more than 30 years in North Carolina. Our mission is advocating for people in North Carolina harmed by the negligence of others, including those harmed by dangerous drugs such as Zantac and its generic versions. Our lawyers have a strong record of success in both settlements and courtroom cases.

If we believe that you have a valid Zantac cancer lawsuit, we will offer to handle your claim on a contingency fee basis. You will not have any out-of-pocket costs to pursue a ranitidine cancer claim.

Our law firm has offices in Raleigh, Durham, Greensboro, Fayetteville, Dunn, Southern Pines and Wilmington.

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