In the United States, about 15 million prescriptions are written for the heartburn drug, Zantac, each year. A portion of these go to people who are pregnant and newborns, who may often be prescribed drugs like Zantac (ranitidine) to treat issues such as heartburn and acid reflux.
Newborns frequently experience acid reflux issues in early life—an observation that is typically attributed to the underdevelopment of certain muscles and other physiological factors. Medical treatment, such as the use of Zantac, can often be prescribed to help ease the pain and discomfort of infant reflux.
However, the safety of drugs like Zantac for babies has been hotly debated among doctors and medical researchers. This debate has become even more urgent following the recent discovery of NDMA, a cancer-causing chemical, in Zantac and ranitidine products, as reported by the U.S. Food and Drug Administration (FDA) in September 2019.
This discovery has created a great deal of alarm among parents of babies who have taken Zantac, as well as mothers who took Zantac while pregnant. Understanding the potential side effects and dangers of Zantac (ranitidine) in babies may be important as you consider alternative treatments for your baby and whether you wish to join others in taking legal action against Zantac manufacturers.
Side Effects Of Zantac (Ranitidine) In Babies
Zantac belongs to a class of drugs known as histamine-2 (H2) blockers, which works by reducing the production of stomach acid in the body. Zantac is a brand name for the generic drug, ranitidine, which is commonly prescribed for the treatment of heartburn, gastroesophageal reflux disease (GERD), ulcers, and related health conditions.
Zantac (ranitidine) is available in both tablet and syrup form, but is generally prescribed to babies in the form of an oral syrup for severe reflux issues. All prescription drugs in the United States are required to undergo rigorous evaluation and testing to determine drug safety before they can be prescribed to patients.
Less is known, however, about the side effects of drugs like Zantac in babies, who can react to drugs differently than adults observed in clinical drug trials.
According to medical experts, side effects of Zantac (ranitidine) in babies may include:
Reflux issues are very common in babies and are expected to improve in time through natural development. When giving drugs like Zantac to babies, it’s important to determine with your doctor whether the benefits of using Zantac for reflux outweigh the potential side effects and health risks.
Is Zantac (Ranitidine) Dangerous For Babies?
If you look at the warning label on Zantac and ranitidine products, you’ll see they come with a disclaimer that the safety and efficacy of treating newborns with these drugs has not been established.
Despite the widespread prescribing of Zantac and ranitidine to babies, multiple studies have indicated that there are several potential risks and dangers of treating babies with anti-reflux drugs. The longer a baby is treated with a drug like Zantac, the greater the risk.
According to research on the effects of Zantac in newborns, potential dangers of giving Zantac to babies include increased risk for:
- bone fractures
- food allergies
- medication allergies
- GI and respiratory infections
- changes in gut bacteria
Evidence of these potential dangers has been known for years. However, more recently, there has been a new wave of concern among parents of babies who have taken ranitidine due to major recalls of Zantac and ranitidine products.
Since September 2019, over a dozen pharmaceutical manufacturers have issued recalls of their Zantac and ranitidine products after they were found to contain toxic amounts of NDMA. This chemical has been linked to several types of cancer and poses the greatest danger to individuals who have been taking ranitidine for months or years on a regular basis.
Stores and pharmacies such as CVS Pharmacy, Target, and Walgreens have also pulled name-brand and generic Zantac products from their shelves to prevent further exposure to this cancerous chemical.
Zantac Recalls And Cancer: Are Babies At Risk?
The U.S. Food and Drug Administration (FDA) released a statement on September 13, 2019 alerting doctors and patients of a discovered contaminant—a carcinogen known as NDMA—in certain Zantac and ranitidine products.
This discovery was made by the independent pharmaceutical research company, Valisure, which detected unsafe levels of NDMA in ranitidine during routine testing.
Overexposure to NDMA over a long period of time may cause or significantly increase a person’s risk for cancer, as well as other health issues such as liver disease and reduced kidney function.
Types of cancer linked to the NDMA in Zantac include:
- stomach cancer
- bladder cancer
- lung cancer
- liver cancer
- kidney cancer
- esophageal cancer
- respiratory tract cancer
- cancer of the blood
- breast cancer
- colorectal cancer
As a drug that is commonly given to babies suffering reflux, one of the biggest questions coming from parents following this recent FDA alert is whether their babies are at risk for getting cancer after being given ranitidine.
Are babies who have been given ranitidine at risk for developing cancer? It’s uncertain at this time. According to medical and scientific experts, NDMA is unlikely to cause cancer unless a person has been exposed to high doses over a long period of time.
However, it may be more difficult to determine the effects of NDMA in babies, who can be more sensitive to drug effects and may be at greater risk for harm. New mothers who took Zantac while pregnant may have also unknowingly exposed their babies to NDMA while in the womb.
If you took Zantac regularly while pregnant, or have given your baby ranitidine to treat reflux, you may be eligible to file a lawsuit against the manufacturers of Zantac products to seek compensation.
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Zantac Cancer Lawsuits
Thousands of lawsuits across the country have been filed against the primary manufacturers of Zantac and ranitidine products on account of their failure to detect NDMA in their products and warn consumers of serious health risks associated with the use of their drugs.
Plaintiffs filing these lawsuits are suing on behalf of themselves, deceased family members, or their babies who were exposed to the NDMA in Zantac. These lawsuits allege that taking Zantac directly caused the development of serious health issues—including various cancers and liver and kidney problems—as a result of the NDMA in Zantac and ranitidine products.
Recent test results of Zantac and ranitidine products showed each tablet containing 3,000 to 31,000 times the FDA-recommended daily limit of NDMA. The oral syrup and liquid forms of ranitidine, which are the forms typically given to babies, have also been found to contain unsafe amounts of NDMA.
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Find Help Filing A Lawsuit Against Zantac (Ranitidine) Manufacturers
If your baby has developed health problems after being given Zantac (ranitidine), or you’re concerned about your baby’s risk for health issues, you may be eligible to file a lawsuit against the drugmakers who failed to warn consumers of all potential dangers of using their drugs.
At Florin|Roebig, our experienced pharmaceutical lawyers can determine whether you have a case to sue Zantac drugmakers and seek compensation for damages.
Call the offices of Florin|Roebig today to schedule a free case evaluation with one of our attorneys to determine your eligibility for filing an individual or class action lawsuit.