Zantac, a medication used to treat heartburn and acid reflux, has been linked to severe health problems.
The Food and Drug Administration has issued a warning about the potential health risks associated with Zantac. These risks include cancer, birth defects, and other serious health problems.
If you have taken Zantac and have experienced any health problems, you may be entitled to compensation.
Our personal injury attorneys at Rosenfeld Injury Lawyers, LLC, are ready to fight for your rights and get you the compensation you deserve. Contact our dangerous drug lawyers toll-free today at (888) 424-5757 for a free consultation.
OTC Ranitidine and Its Health Effects
Zantac is a medication often used to relieve heartburn and gastroesophageal reflux (GERD). It is an antacid medication that blocks the production of stomach acid. Zantac is available over-the-counter (OTC) for heartburn relief. It is also available by prescription.
Common side effects of Zantac are:
- Stomach pain
- Dry mouth
- Rash (with itching)
- Hives (with itching)
- Growths on the skin (skin tags)
- Lip swelling or cracking
- Tongue discoloration
- Stomach or intestinal ulcers
Medical Research on Zantac
Zantac is in the Food and Drug Administration Pregnancy Category B. This means that Zantac did not cause an increased risk of birth defects in animal studies, but no adequate, well-controlled studies in pregnant women have been conducted.
It is not known whether Zantac will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
Dangerous drugs can often get a free pass from the Food and Drug Administration. But Zantac has been going through a tough time lately, with doctors and patients alike questioning its safety.
Prescription Zantac Treats the Following Illnesses
- Ulcers, prevent ulcers caused by NSAIDs
- Treat gastroesophageal reflux disease (GERD)
Zantac is a medication that reduces acid in the stomach. It does not contain aspirin or other salicylates. If you have any questions about whether Zantac is suitable for you, ask your doctor before taking it.
Forms of Zantac Medications
- Zantac tablets cause fewer side effects than other anti‑ulcer medicines.
- Ranitidine hydrochloride capsules, also known as Zantac, are an acid suppressor on the World Health Organization’s List of Essential Medicines.
Prescription ranitidine hydrochloride is an ulcer medication that blocks acid production in the stomach. Zantac’s acceptable daily intake limit was limited to 125 milligrams per kilogram of body weight.
Ranitidine tablets manufactured by GlaxoSmithKline are used to reduce the amount of acid in the stomach. This is done by blocking histamine, an inflammatory hormone.
Zantac is manufactured by:
- Mylan pharmaceuticals
- Appco Pharma LLC
- Precision Dose Inc.
While many Zantac manufacturers exist, Roche Laboratories, Inc. and Glaxo Wellcome, Inc. are the top Zantac manufacturers globally.
Zantac Recommended Dosage
Zantac has been available in both 150 and 300 mg capsules. The standard dosage for treating acid reflux is one pill every 6-8 hours as needed.
The typical dosage for treating heartburn is one pill every 12 hours as needed. The maximum recommended dose is two pills a day.
Efficacy of Zantac Drug
Zantac does not cure acid reflux disease. It only treats the symptoms of heartburn, nausea, etc. Not treating your condition could result in serious health problems, such as cancer.
Zantac is not meant to be used long-term. Once your symptoms have disappeared, you should stop taking the drug.
Zantac Inception and Launch
Ranitidine products have been available since the 1980s. Zantac is a brand name for the H2 receptor drugs manufactured by GlaxoSmithKline.
In 1982, after a series of clinical trials, Boehringer Ingelheim introduced Zantac in India and Japan. Zantac was introduced in the US market in 1984 and became the best-selling prescription drug for over a year.
Zantac Drug Companies Effort to Prevent Generic Production
The drug companies that make Zantac have been against cheaper generic versions of the popular acid blocker since its patent expired in 2007.
While these drug companies have not succeeded thus far, the companies are still trying to stymie generic alternatives for Zantac, one of the best-selling drugs worldwide.
The heartburn drug, Zantac, has been found to cause cancer in laboratory rats and mice. However, this evidence was not deemed convincing enough to ban the drug.
Zantac is an antacid that reduces stomach acid levels by inhibiting histamine H2 receptors.
In 1991, the Food and Drug Administration issued a warning about Zantac’s cancer-causing capabilities because of data from animal studies.
However, the Food and Drug Administration did not feel that this evidence was strong enough to obtain a warning label for Zantac. Animal studies have found that Zantac causes cancer of the thyroid, lung, colon, liver, and mammary glands.
The Food and Drug Administration required further testing and required all of the data to be submitted on January 31, 1993. As a result, Zantac is the best-selling drug in its class.
The next step for the Food and Drug Administration is to review the data that has been submitted and then make a decision.
Zantac lawsuits have been filed by several people who experienced organ failure and liver damage after taking ranitidine.
Cancer Risks Emanating for Zantac Use
Zantac is a medication that has been used for several decades to treat a variety of diseases. It remained on the market because it has been an effective treatment for conditions such as ulcers, gastritis, and reflux disease.
One of the more severe side effects of Zantac is that it has been shown to increase the risk of different types of cancer, such as stomach and esophageal cancer. The increased risk may occur with or without additional risk factors present.
A recent review of clinical trials has shown that Zantac increases cancer risk in different people who take the medication. The U.S. Food and Drug Administration (FDA) has included cancer risks as a specific side effect of Zantac.
The Food and Drug Administration has also explained that cancer exposure depends on a person’s overall risk of developing cancer. In addition, other factors may affect an individual’s risk of developing cancer.
People who have a history of stomach or esophageal problems should be especially wary about using Zantac because of the potential cancer exposure.
The Food and Drug Administration Advice to Patients Using OTC Ranitidine Drugs
The U.S. Food and Drug Administration (FDA) advises consumers not to purchase or use over-the-counter (OTC) Zantac products. These products are used in adults for the short-term (4 to 8 weeks) treatment of frequent heartburn.
While these products may be available without a prescription, they are drugs that require careful use. The Food and Drug Administration provided this information in a public health advisory on April 9, 2009.
The agency has found that OTC ranitidine drugs are not generally recognized as safe and effective. The Food and Drug Administration’s advice to patients taking Zantac is to immediately seek emergency medical attention if they experience symptoms similar to an allergic reaction.
Patients who have developed cancer or experienced problems with stomach bleeding should tell their doctor before using Zantac.
Compensation for Zantac Victims
The makers of the drug Zantac have been ordered to pay out a settlement for $3.35 million. The amount is one of the largest pharmaceutical settlements in Food and Drug Administration history.
The settlement was made on May 2, 2014, after a 7-year investigation by the United States government. The settlement is for Zantac injuries after 1999 when the Food and Drug Administration had first approved the drug for use.
The settlement covers those who suffered from ulcers, internal hemorrhaging, and other issues resulting from taking the medication. The makers of Zantac, GlaxoSmithKline, released a statement that they will not admit fault or guilt in agreeing to the settlement.
In 2013 the Food and Drug Administration had approved a new warning label for Zantac, stating that it can cause acute interstitial nephritis. Symptoms of this condition include swelling of the tissues in the kidneys, leading to a loss of kidney function that can result in hospitalization or death.
On April 1, 2020, the Food and Drug Administration announced it was asking for a voluntary recall of Zantac meds and products due to an increased risk of cancer.
The agency began investigating the side effects of Zantac after new studies showed an association between the ingredients and certain types of cancers, including stomach and esophageal cancer.
The recall also affects prescription Ranitidine HCL, which is used for conditions such as gastroesophageal reflux disease (GERD).
Food and Drug Administration Safety Communication
The agency has asked manufacturers to recall the products by May 1, 2020. The agency first issued a safety communication asking manufacturers to reconsider their use of the drug back in April 2019.
There are approximately 300 million products currently being sold worldwide. However, the agency does not have complete information for all the products. Patients should be aware that ranitidine recall does not appear on the agency’s list of recalled drugs for 2020.
People who are currently using prescription ranitidine should talk to their doctor about safer alternatives before making any changes to their medication regimen.
The agency is also advising healthcare professionals and patients to report any adverse effects related to the drug to the agency’s Adverse Event Reporting System.
Do You Suffer From Zantac Poisoning? For Assistance, Contact Us
Has Zantac injured you or a loved one? If so, you may be entitled to compensation.
Rosenfeld Injury Lawyers, LLC is dedicated to helping the victims of defective drugs and medical devices. We have the experience and resources necessary to fight for your legal rights.
Contact us today toll-free at (888) 424-5757 for a free consultation!