We take prescription and over-the-counter medications to ease symptoms and cure, halt, or prevent disease. We know many drugs can cause side effects that make us feel ill. But we don’t imagine that medications can contain harmful impurities. However, it can happen.
For example, recently, the heartburn and acid reflux drug Zantac — known as ranitidine in its generic version — was recalled from pharmacy shelves as it may contain unacceptable amounts of potentially cancer-causing compounds.
On April 1, 2020, the FDA asked manufacturers to withdraw all ranitidine products from the market. The recall was prompted by test results showing these medicines may contain unacceptable amounts of the substance N-Nitrosodimethylamine (NDMA), classified by the International Agency for Research on Cancer and the World Health Organization as possibly carcinogenic to humans.
NDMA can cause:
- Liver cancer
- Kidney cancer
- Gastric cancer
- Colorectal cancer
- Leukemia or
- Non-Hodgkin’s Lymphoma.
Tests performed by FDA and third-party laboratories also showed that the presence of the carcinogenic substance in the drug isn’t the result of poor manufacturing practices, but the molecular makeup of ranitidine itself. When exposed to heat — especially when transported or stored for long periods — the molecular makeup breaks down and forms NDMA.
Many people relied on Zantac for heartburn relief. First introduced in 1981, it was the world’s biggest-selling prescription drug, the first with global annual sales exceeding $1 billion. It then became available for over-the-counter use and several more effective medications eclipsed it, but it was still widely used and less expensive than other drugs.
If you took Zantac before the big recall you might be wondering how worried you should be. Maybe you stored the medicine weeks or months prior to taking it and now you read that storing it for long periods makes it even more dangerous. What should you do?
What Happens After You Find Your Medication Was Recalled?
As millions of people have taken Zantac for decades, there’s a high number that is potentially affected. Zantac side effects may be mild or severe, but regardless, they should be looked into by your doctor.
If you took ranitidine before the recall came out and you have symptoms, such as kidney and bladder pain, the next step is to contact your doctor immediately. A physician can test you and determine whether you are suffering side effects associated with the recalled drug. You’ll also discuss alternative medications for your condition.
Because, like you, your doctor was not adequately warned by drug manufacturers, they may have prescribed you the drug without knowing there would be adverse side effects.
If you have medical expenses because you took Zantac, you can join the consumers who are holding the manufacturers accountable as drugmakers have a legal responsibility to warn the public of any dangers associated with their products.
How Can Risks to Human Health Go Unnoticed for Decades?
Ranitidine has been widely used for 40 years. How could the risk to human health have gone unnoticed for so long? It’s unbelievable that the FDA can just be finding out now that ranitidine has such dangerous side effects.
Valisure, the online pharmacy company that first detected concerning levels of NDMA in ranitidine during routine testing and filed a detailed citizen petition to the FDA, alleges that there were some limitations in the first safety studies involving the drug.
Zantac’s original manufacturer, Glaxo — currently GlaxoSmithKline — published some studies in the ’80, but these appear not to have looked for NDMA or looked for it with a detection method designed for food products, that does not directly measure the toxin.
NDMA is a possible human carcinogen even at low levels. The longer the exposure to this carcinogen, the higher the chances are for developing several different types of cancer and other side effects such as abdominal cramps, dizziness, fever, headaches, nausea or reduced liver, kidney, and lung function.
That’s why various drugmakers, including Sanofi and Boehringer Ingelheim, are now being accused of manufacturing Zantac with the carcinogenic contaminant. Injured consumers are filing lawsuits across the country arguing that the manufacturers knew or should have known about the health risks.
About the author:
Miguel Leyva is a case manager at Atraxia Law. Miguel works alongside an expert team to assist consumers injured by defective drugs, helping them properly understand the source of injury and assisting in the process of recovering compensation.