Zantac Class Action Lawyer: Tim Misny

Zantac Recall

The Food and Drug Administration (FDA) reported that some heartburn or acid-reducing medications contain a cancer-causing ingredient. Ranitidine is the medication, and it is available by prescription and sold over the counter by the brand names Zantac and Tritec.

The probable cancer-causing ingredient is N-nitrosodimethylamine (NDMA). According to the FDA, Zantac contains 26,000 times more of this ingredient than the FDA allows.

Ranitidine – Medications Also Known as H2 Blockers

Ranitidine is a medication that belongs to the class of drugs known as H2 blockers. It is primarily used to reduce the production of stomach acid in the body. The drug works by blocking the action of histamine, a substance that stimulates the secretion of acid in the stomach.

Ranitidine is commonly prescribed to treat various conditions related to excess stomach acid production, such as peptic ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome. It can help alleviate symptoms like heartburn, acid indigestion, and stomach pain.

The medication is available in both prescription and over-the-counter forms. In prescription strength, ranitidine is typically taken orally in the form of tablets or capsules. For over-the-counter use, lower-dose versions of the drug are available as tablets, chewable tablets, or syrups.

Medications Containing Ranitidine

Zantac

Zantac is one of the most well-known brands of ranitidine. It was commonly used to relieve symptoms of gastroesophageal reflux disease (GERD), such as heartburn and acid indigestion. The benefits of taking Zantac included reducing the production of stomach acid, alleviating symptoms of GERD, and promoting healing of esophageal and stomach ulcers. Possible side effects could include headache, dizziness, diarrhea, constipation, and, rarely, more serious adverse reactions.

I have been helping clients with their Zantac cancer lawsuits, and their product liability claims. Pharmaceutical giants need to held accountable, to push for change in the pharmaceutical industry, so no one else is harmed by simply talking a pill that was supposed to help you. If you’ve taken Ranitidine in the past and have been diagnosed with cancer, call me. You may be able to join the class action Zantac lawsuit.

Ranitidine Tablets

Generic ranitidine tablets were available under various names and were used to treat conditions like peptic ulcers, Zollinger-Ellison syndrome (a rare condition characterized by excessive stomach acid production), and GERD. The benefits of taking genetic ranitidine tablets were identical to Zantac, including reducing stomach acid levels and providing relief from associated symptoms. There is even prescription ranitidine available. Side effects included gastrointestinal disturbances, headache, dizziness, fatigue, and in rare cases, more severe reactions like blood disorders or liver problems.

Ranitidine Syrup

Ranitidine syrup, also available under various brand names, was commonly prescribed for infants and young children with GERD or acid reflux. The syrup formulation made it easier to administer to young patients. Side effects included diarrhea, constipation, dizziness, and allergic reactions.

Acid Reducing Medications

Acid reducing products containing ranitidine were available as over-the-counter medications to provide temporary relief from heartburn, acid indigestion, and sour stomach. The benefits of using these products were quick relief from relatively mild symptoms associated with excess stomach acid.

Ranitidine Injection

Ranitidine was also available as an injectable medication. Primarily used in hospital settings to treat conditions like bleeding ulcers or severe cases of GERD where oral administration was contraindicated. The benefits of using ranitidine injection included rapid onset of action and the ability to control stomach acid production in critical situations. Possible side effects were similar to other forms of ranitidine, including headache, dizziness, and gastrointestinal disturbances.

What is NDMA?

N-Nitrosodimethylamine (NDMA) is a chemical compound that belongs to the group of nitrosamines. It is classified as a probable human carcinogen by various regulatory agencies, including the United States Food and Drug Administration (FDA) and the International Agency for Research on Cancer (IARC). NDMA is not intentionally added to medications but can be formed as an impurity or byproduct during certain manufacturing processes or under specific conditions.

NDMA has been found to be potentially harmful to human health due to its carcinogenic properties. In the context of medicine, NDMA contamination has been a concern when it is detected in certain medications, particularly those that contain ranitidine. Ranitidine is an H2 blocker used to reduce stomach acid production and alleviate conditions like peptic ulcers and reflux disease. However, some ranitidine products were found to contain trace amounts of NDMA above acceptable levels.

NDMA contamination in medications may occur due to the breakdown of certain ingredients or the presence of precursors that can react to form NDMA under specific conditions. In the case of ranitidine, it has been suggested that NDMA could be formed when the drug is exposed to high temperatures, such as during storage or distribution. The exact mechanisms of NDMA formation in ranitidine products are still under investigation.

Various regulatory authorities, such as the FDA and other health agencies worldwide, have taken action to address the issue of NDMA contamination in medications. These actions have included recalls, market withdrawals, and restrictions on the use of certain ranitidine products. Manufacturers have been required to conduct testing and implement measures to prevent or minimize NDMA formation in their products.

Individuals who have taken medications affected by NDMA contamination were prescribed or purchased ranitidine products or other medications that were found to contain NDMA. The specific demographics can vary, as ranitidine and other medications are commonly used by people of different ages, for gastrointestinal disorders.

The potential side effects of NDMA exposure are primarily associated with its carcinogenic properties. Prolonged exposure to NDMA may increase the risk of developing certain cancers, such as liver, kidney, lung, and gastrointestinal cancers. It is important to note that the risk of developing cancer from NDMA exposure is generally associated with long-term use of contaminated medications or high levels of exposure.

However, it’s crucial to highlight that the level of NDMA in medications can vary, and the risk posed to an individual depends on multiple factors such as the duration and dosage of medication use. Not everyone who has taken NDMA-contaminated medications will develop cancer, as individual susceptibility can vary.

If you’ve taken ranitidine drugs and were diagnosed with cancer, it is imperative that you call me as soon as possible. These circumstances are devastating, and my heart goes out to everyone who is suffering. Pharmaceutical companies must be held accountable, and I’ll Make Them Pay!®

Why is NDMA Harmful?

This chemical was originally developed for the production of rocket fuel. After high levels were found in the air, water and soil samples of nearby manufacturing plants, its use was halted. 

NDMA is known to leach into the soil, runoff and contaminate nearby water. It enters the body when someone eats food made with or drinks water contaminated with NDMA.

Those who took Ranitidine (Zantac) regularly should monitor themselves for symptoms of overexposure to NDMA.

 Symptoms include:

• Fever
• Nausea
• Vomiting
• Jaundice
• Dizziness
• Abdominal cramps

If you experience any of these symptoms and/or recently received a cancer diagnosis after taking Ranitidine regularly, call me today and I’ll Make Them Pay!®

Cancer and NDMA

N-nitrosodimethylamine (NDMA) containing medications have been linked to cancers including:

• Bladder
• Colorectal
• Esophageal
• Intestinal
• Kidney
• Liver
• Ovarian
• Pancreatic
• Stomach
• Testicular
• Uterine

Other types of cancer may also be linked to Zantac.

Process Pharmaceutical Manufactures Make to Ensure A Drug Is Safe for Consumer Use

Research and Development

Pharmaceutical companies invest significant resources in researching and developing new drugs. This involves identifying potential drug candidates, conducting laboratory experiments, and evaluating their efficacy and safety profiles. The Zantac lawsuits are important because the safety of the consumer has been compromised.

Preclinical Studies

Before testing on humans, drugs undergo preclinical studies using in vitro (test tube) and in vivo (animal) models. These studies assess the drug’s pharmacological activity, toxicity, and potential side effects. Data from preclinical studies are submitted to regulatory authorities for approval to proceed to clinical trials.

Clinical Trials

Clinical trials involve testing the drug on human subjects in carefully monitored phases. Phase I trials assess the drug’s safety and dosage range in a small group of healthy volunteers. Phase II trials expand the study to a larger group to determine efficacy and to further evaluate safety. Phase III trials involve a larger population to confirm effectiveness, monitor side effects, and compare the drug against existing treatments. Data from clinical trials are submitted for regulatory approval.

Regulatory Approval

Regulatory authorities, such as the FDA in the United States or the European Medicines Agency (EMA) in Europe, review the accumulated data from preclinical and clinical studies. They evaluate the drug’s safety, efficacy, manufacturing processes, and labeling information to determine whether the drug can be approved for market authorization.

Good Manufacturing Practices (GMP)

Pharmaceutical manufacturers adhere to stringent GMP guidelines to ensure the quality, safety, and consistency of their drug products. GMP covers various aspects of manufacturing, including facility design, equipment validation, personnel training, documentation practices, and quality control testing. Regular inspections are conducted to verify compliance.

Post-Marketing Surveillance

After a drug is approved and marketed, ongoing monitoring takes place to detect and evaluate any potential adverse effects that may arise in larger populations. Reports of adverse reactions from healthcare professionals and patients are collected and analyzed to identify any safety concerns. Regulatory agencies closely monitor the drug’s safety profile and may take appropriate action if needed, such as issuing warnings or recalls.

Pharmacovigilance

Pharmaceutical manufacturers have pharmacovigilance systems in place to continuously monitor the safety of their drugs. They collect and analyze safety data, conduct risk-benefit assessments, and communicate any significant findings to regulatory authorities, healthcare professionals, and the public. Adverse event reporting systems are established to facilitate the reporting of any suspected side effects by healthcare providers and patients.

These processes collectively aim to ensure that pharmaceutical drugs are safe for human use. The Zantac cancer risk has only recently been discovered, and for many, it is too late. I want to help. You may have medical bills piling up, or have been unable to work because of treatment. I am here for you, and to get you the help you need.

Can Pharmaceutical Manufacturers Be Held Accountable?

When you take medication, you entrust the pharmaceutical company to ensure its safety. If you, or someone you love were taking Zantac or another variation of Ranitidine and were diagnosed with cancer, call me right now and I’ll Make Them Pay!®

Products containing Ranitidine may still be available, however, most companies have removed their ranitidine medication from the market to avoid liability claims. Product removal does not mean they aren’t responsible for your injury!

Even when a drug receives FDA approval, it does not protect the drug manufacturer from litigation. Drug companies cannot hide behind FDA approval. It can take years before the potential for harm is identified despite numerous studies and testing.

FDA Rules On NDMA

The FDA has established acceptable daily intake (ADI) limits for NDMA, which determine the maximum amount of NDMA exposure considered safe over a person’s lifetime. These limits are based on scientific assessments and take into account potential cancer risks associated with NDMA exposure.

When it comes to medications, the FDA has set specific thresholds for the presence of NDMA. If the level of NDMA detected in a medication exceeds these thresholds, regulatory actions can be taken. The thresholds may vary depending on the medication and its intended use.

In the case of ranitidine, the FDA has issued warnings and taken regulatory actions due to the presence of NDMA in some ranitidine products. The agency has advised patients to stop taking any ranitidine products and requested manufacturers to recall and withdraw ranitidine products from the market.

The FDA has also provided recommendations for patients who were taking ranitidine and require alternative treatments. They advise consulting healthcare professionals to explore alternative medications or therapies that can effectively manage the conditions for which ranitidine was prescribed.

It is important to note that the FDA continues to evaluate the potential risks associated with NDMA and takes necessary actions to protect public health. These rules and guidelines are subject to change as new information emerges and scientific assessments evolve.

Call Tim Misny With Your Zantac Cancer Lawsuit

Manufacturers of Zantac and other Ranitidine-containing medications will face numerous lawsuits. Pharmaceutical litigation is a complex process, and requires the help of an experienced litigation attorney. I have helped hundreds of clients recover significant monetary damages for their product liability claims.

If you were taking a heartburn or antacid medication containing Ranitidine and now have cancer, you may be entitled to receive significant compensation. Don’t wait – call me as soon as possible!