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What Does the FDA Say About Zantac?

The Food and Drug Administration (FDA) issued a formal request for companies to pull Zantac from their shelves in April of 2020 after discovering “unacceptable amounts” of the NDMA carcinogen in the medication. Adhering to the directives of the FDA, dozens of companies have voluntarily issued a Zantac recall.

Important Information from the Food and Drug Administration

Belonging to a class of drugs known as H2 blockers, Zantac (ranitidine) was introduced in the 1980s primarily to treat and prevent heartburn. The drug first came to the FDA’s attention as potentially dangerous in the 1980s.

At that point, testing began demonstrating a link between the NDMA found in ranitidine (Zantac’s active ingredient) and cancer. Concerned consumers started looking to see what the FDA said about the drug. As testing has continued, the FDA has responded accordingly.

FDA Findings and Statements:

  • Laboratory tests and evaluations performed by third-party laboratories show that while levels of NDMA in ranitidine increase in nearly all storage conditions, the increase is notably higher when the drug is stored at higher temperatures that mirror those associated with distribution and handling of the drug.
  • NDMA levels increase over time—making older samples riskier than newer samples.
  • In 2019, the FDA warned the public about possible cancer risks associated with Zantac.
  • The following year, the FDA issued a statement directing manufacturers to remove all prescriptions and over-the-counter prescriptions from the market while investigations into the drug’s safety continued.
  • Manufacturers are continuing to work to increase the drug’s safety. Once the product can prove itself stable and safe, the FDA will consider reintroducing Zantac to the market.

If you (or a loved one) have taken Zantac for a prolonged period of time and have received a cancer diagnosis, our Zantac lawsuit attorneys can advise you on your legal rights.

Known Carcinogens Found in Zantac

Ranitidine hydrochloride acts as the active ingredient in Zantac. Once ingested (in either pill or liquid form), ranitidine converts into NDMA—making NDMA a natural by-product of the drug. The World Health Organization (WHO) and Environmental Protection Agency (EPA) list NDMA as a “probable human carcinogen.”

Additional Effects of Long-Term Zantac Use

  • Problems with liver and kidney functioning (including enlargement of the organ, reduced levels of organ function, and organ failure)
  • Cardiac complications that include irregular and rapid heartbeats
  • Complications with the nervous system
  • Jaundice
  • Gastrointestinal complications that include cramping, constipation, and diarrhea

If you have used Zantac for an extended period of time (whether prescribed by a doctor or taken in its over-the-counter form) and have experienced any of these physical ailments, you may have legal grounds for bringing a claim against the makers of Zantac.

You May Qualify for a Zantac Lawsuit

Given the fact that a single dose of Zantac exceeds the maximum daily amount of safe NDMA consumption, anyone who has used the drug for any length of time has likely ingested dangerously high levels of this carcinogen.

Criteria for Qualification:

  • You have taken Zantac regularly for a minimum of six months.
  • You have used the drug as it was intended to be used.
  • You have been diagnosed with liver, bladder, stomach, breast, intestinal, esophageal, or colorectal cancer.
  • The labeling on the drug failed to properly warn you of the risks associated with usage.

Documentation that can be used to prove your case includes pharmaceutical records and medical records demonstrating a doctor’s prescription for the medication and any medical conditions that have developed as a result.

Damages You May Be Able to Claim:

  • Medical Bills: Doctor visits, emergency room and hospital stays, surgical procedures, rehabilitation services, chemotherapy and radiation services, medications, and more
  • Lost Incomes: Current lost wages, reduced earning capacity, and any change in income resulting from your injuries or illness
  • Pain and Suffering: Mental anguish, mental health counseling services, and medication for depression, anxiety, PTSD, and more

In order to build a successful case, you will need to prove that your case meets the prescribed criteria and you have suffered an injury or illness as a direct result. Our attorneys can review your case and work with you to gather the appropriate documentation before bringing your case before a judge.

Work with Our Lawyers to Hold Manufacturers Responsible

If you are facing an uphill medical battle caused by your use of Zantac, you are not alone. The Zantac lawsuit lawyers at Chalik & Chalik Injury Lawyers will get to the bottom of your case and fight for the compensation you deserve. The first call is free, and the time to act is now. Call (855) 529-0269 today to speak with a member of our team for free.