FDA Cancer Recall
The United States Food & Drug Administration (FDA) announced a Zantac recall in September 2019 due to an increased risk of cancer. The FDA expanded the recall on April 1, 2020, to request that both Zantac and ranitidine, its generic form, be removed from the marketplace. This means that no form of this medication should be manufactured or sold, and that anyone who is taking it contact their doctor for advice on what to do next.
While Zantac and its generic ranitidine forms have been used by many people for over two decades, there were suspicions that it may have been linked to cancer since the 1980s. These suspicions were confirmed by private-laboratory tests and brought to the FDA’s attention, and this led to the September recall. The FDA then conducted further tests, which confirmed the link with cancer, and the drug is now banned from sale and use.
If you or a family member has been taking Zantac, you may be entitled to compensation through a lawsuit – whether or not you have been diagnosed with cancer. Depending on the circumstances, this may be a class action lawsuit, an individual lawsuit, or a wrongful death lawsuit if someone has died. The experienced drug injury lawyers at the Terry Bryant law firm provide a free evaluation to examine the facts of your individual situation and show you how we can help.
Call us today at (713) 973-8888 or toll-free 1 (800) 444-5000.
Zantac Recall and Cancer
The connection between Zantac and cancer is due to the presence of a contaminant known as N-Nitrosodimethylamine (NDMA). NDMA can cause cancer in humans because it can modify deoxyribonucleic acid (DNA), the substance in cells that contains our genetic code. This genetic code has instructions that tells cells how to do processes such as building the proteins in our body or dividing properly for reproduction. If there are errors in the code, cells can start reproducing widely, which is how cancer is created.
Human cells typically grow and divide to form new cells, according to the National Cancer Institute. When cells grow old or are damaged, they usually die or are destroyed by our immune system. New cells replace them.
If cancer develops, this process breaks down. As cells become more abnormal or old, damaged cells survive when they should not and new cells form when they are not needed. The extra cells can divide without stopping and form masses of tissue, called tumors. Cancerous tumors are malignant, which means they can invade nearby tissues. As they grow, some cancer cells travel to distant parts of the body and form new tumors far from the original one.
Zantac, made by Sanofi, is known as an H2 blocker. It treats ulcers and heartburn because it blocks the body’s signal to the stomach to produce acid. Low levels of NDMA may not do harm, but the levels found in recent laboratory tests were much higher than the FDA limits.
According to Harvard University, the FDA did not find unacceptable levels of NDMA in many of the samples they tested. However, when testing further, it was found that:
- The NDMA in some ranitidine products increases over time. The older a ranitidine product is and the longer the length of time since it was manufactured, the greater the level of NDMA.
- NDMA increases with higher temperatures. This includes temperatures the medication is exposed to during distribution to stores and storage in the home.
- NDMA levels increase in ranitidine even under normal storage conditions.
Consequently, based on new testing and the tests from outside laboratories, the FDA determined that the link to cancer is strong enough to pull ranitidine completely off the market.
Cancers said to be linked to NDMA are usually part of the gastrointestinal system that the drug is geared to and include cancers of the …
- Ovary and uterus
If you have been taking Zantac or ranitidine and are concerned about your cancer risk, call a dangerous drug lawyer at Terry Bryant to discuss your individual situation.
Call today at (713) 973-8888 or toll-free 1 (800) 444-5000.
Zantac Cancer Lawsuit
Now that the link between Zantac and cancer has been made public, people who have used the product, especially those who have cancer, may be entitled to receive compensation for the damages they suffered through a lawsuit. Some lawsuits have already been filed, claiming that Sanofi and Boehringer Ingelheim knew about studies showing a cancer link for decades but concealed this from the public so the companies could make more profits.
Ordinarily, because drugs always have the potential for side effects, drug manufacturers are not strictly liable for harm caused by taking them. However, it is different when manufacturers knew of and concealed dangers to the public. If the drug manufacturer failed to warn about risks, failed to provide information about risks to the FDA, or a safer alternative could be used, the manufacturer could be held liable in a lawsuit.
Zantac Lawsuits Related to Injuries from Taking the Drug
If you or a loved one has developed cancer after taking Zantac, you may seek compensation through an individual personal injury suit against the manufacturer. These are lawsuits that claim drug makers manufactured, marketed, and sold drugs contaminated with unsafe levels of NDMA and failed to disclose the risks to the government and public.
To win your lawsuit, your attorney would have to prove that the parties you are suing (the defendants) …
- Owed you a reasonable duty of care (such as to manufacture and sell a safe product)
- Breached that duty of care
- Caused you to receive injuries or damages as a result.
Compensation You May Receive in a Zantac Injury Case
While drug injury cases can become class actions, it is also possible to proceed with an individual drug injury lawsuit. In a successful personal injury lawsuit, you may receive compensation for both economic and non-economic damages. In some cases, punitive damages, meant to punish and make an example of a defendant, may be awarded as well. In drug injury cases involving large pharmaceutical companies, like Sanofi, punitive damages may send a warning to the company, and other drug manufacturers, that bringing products to market knowing that they can cause serious illness could result in really large settlements.
Economic damages are meant to reimburse you for monetary expenses, such as:
- Cost of medical, hospital, and nursing care resulting from injuries
- Loss of wages and earning capacity.
Non-economic damages are to compensate you for the negative effects on your life, such as:
- Pain and suffering, both physical and mental, caused by the injuries
- Loss of consortium and enjoyment of life.
You may file a personal injury lawsuit against any negligent party who might have been aware of the cancer-causing effects, including drug manufacturers, salespeople, distributors, pharmacies, and doctors. If the cancer resulted in the death of a loved one, there may be grounds for a wrongful death lawsuit. This is a type of personal injury suit where damages are paid to the family or estate of the person who has died.
Damages You May Receive in a Zantac Lawsuit
The amount of damages you may win in a successful lawsuit would depend on a number of factors, such as:
- The type and severity of cancer and how it affects your life
- Whether you will need long-term care and treatment
- Your age and earning capacity
- The skill and experience of your personal injury attorney.
Class Action Zantac Cases
When there are a large number of people who have similar injuries from taking the same drug, it may be best to pursue a strategy different from a typical personal injury claim. Many claimants, all with similar injuries, can join in a class action case. In the case of drug injuries, this approach may be the strongest legal option. When many people suffer from the same type of cancer after having taken Zantac, there is good opportunity for a Zantac class action case.
Are Zantac and Ranitidine the Same?
Ranitidine is a generic form of brand-name Zantac and is made by several companies. They are all required by the FDA to have the same active ingredients, in the same proportion, and the same warning as their brand-name counterpart. The FDA ban is on all forms of ranitidine, chemically known as ranitidine hydrochloride.
Both forms have been available over the counter and by prescription, depending on the strength involved. Some of the most common Zantac brands and generic ranitidine brand names are:
- Zantac 150 Tablets
- Zantac 150 Maximum Strength
- Zantac 75 Tablets
- Wal-Zan 150
- Wal-Zan 75
- Ranitidine for Heartburn Relief
- Ranitidine Acid Reducer, Acid Control, or Acid Controller
Ranitidine Recall by the FDA
The FDA announced two voluntary recalls of ranitidine-containing products in January, by Appco Pharma LLC and Northwind Pharmaceuticals, which sold prescription ranitidine tablets made by Glenmark Pharmaceutical Inc. The current ban is for all ranitidine products, which, since Zantac was introduced in 1981, had become the 50th most prescribed medication in the United States.
How Does the Zantac Recall Relate to a Cancer Risk?
NDMA is in water and foods, including meats, dairy products, and vegetables. The FDA has asked companies to recall products if their testing shows levels of NDMA above the acceptable daily intake (96 nanograms or 96 billionths of a gram).
Some of the ranitidine drugs tested by the FDA showed far more NDMA than that acceptable level, according to test results published in November 2019. NDMA found in one sample was nearly 30 times the acceptable daily intake. Most of the tested drugs were above that level of NDMA, making the Zantac recall and cancer fears more reasonable.
A Zantac cancer lawsuit could provide compensation for an individual whose cancer is caused by using the drug. Talk to a Zantac attorney at Terry Bryant law firm to find out if you have a case.
Call us at (713) 973-8888 today.
How Does NDMA Get into the Body?
You can ingest NDMA directly or indirectly in many ways, according to the Environmental Protection Agency (EPA), including:
- Eating smoked or cured meats and fish
- Eating food containing alkylamines (a chemical compound derived from fatty acid), which can cause NDMA to form in the stomach
- Drinking contaminated water
- Drinking malt beverages, such as beer and whiskey
- Using shampoos, cleaning, and cosmetic products containing NDMA
- Inhaling cigarette smoke
- Being exposed at workplaces such as tanneries, pesticide manufacturing plants, and rubber and tire plants.
The EPA states that there is no safe, permissible NDMA exposure or occupational limit. NDMA is regulated as a “potential occupational carcinogen.” Any exposure should be reduced to the lowest possible levels.
As a side effect of digesting ranitidine, NDMA might be created within the body, according to an article in Scientific American. A 2016 Stanford University study involved 10 healthy volunteers who took 150 milligrams of Zantac. When their urine was later tested, NDMA levels found in it exceeded 47,000 nanograms. The actual amount created in their bodies may have been much higher, because most of it would have been metabolized before reaching their urine. Sanofi claims that the study involved heating the sample drugs and adding other chemicals, either of which may have created NDMA.
What Alternatives Are There to Zantac and Ranitidine?
Now that the FDA has stated that people should stop using ranitidine, they should talk to a healthcare professional about other options. Alternatives, according to the University of Virginia Health System, include:
- Using a different H2 blocker, such as Pepcid (famotidine) or Tagamet (cimetidine)
- A proton pump inhibitor (Prilosec, Nexium, Protonix)
- Discontinuation of these medications (Patients may start using them and assume they need to continue, but that might not be the case. Long-term use carries some side effects.) ***Do not stop taking a prescription medication without first consulting with your doctor. Discontinuing a prescribed medication without your doctor’s advice can result in injury or death.***
- Eating smaller meals
- Not lying down after eating
- Losing weight if you’re overweight
- Not eating foods that make heartburn worse (fatty and spicy foods, tomato-based sauces, alcohol, carbonated beverages, caffeine, and chocolate)
- Elevating the head of your bed
- Wearing loose-fitting clothes.
A Zantac Cancer Lawsuit May Be the Right Option
Drug companies have billions of dollars at their disposal. Anyone who has been harmed by Zantac or ranitidine may be entitled to compensation, but you need to level the playing field by getting help from attorneys who can get results. The Houston-based legal team the accident & injury law firm of Terry Bryant has a history of successfully helping clients injured by dangerous drugs.
If you or a family member is in this situation, call us today at (713) 973-8888 or toll-free 1 (800) 444-5000 for a free consultation.