FDA Recalls All Zantac (Ranitidine) Heartburn Drugs
As of April 2020, Zantac and ranitidine-based heartburn generics are no longer available in American stores. The Food and Drug Administration (FDA) recently announced a complete recall of the medication and urged its consumers and patients to ask their doctors about other treatment options.
The drug, which has been on the market for nearly 40 years, was found to be contaminated with cancer-causing chemical N-nitrosodimethyalmine (NDMA). After an independent research lab found evidence of NDMA contamination and blew the whistle on Zantac last year, the FDA funded its own studies to see if they could replicate the results. The lab’s allegations were proven correct: Active ingredient ranitidine is unstable and, in certain conditions, separates into various component molecules. One of them is NDMA.
The Gaps in the FDA Approval Process
If a drug naturally decays to produce a dangerous chemical, how did it even make it to the marketplace? Unfortunately, though the FDA is responsible for making the final decision on whether a drug is safe enough for consumers to use, the agency relies on tests conducted by drug makers to guide its judgement. This leaves plenty of room for unethical pharmaceutical companies to omit unfavorable results or even fudge data completely. Drug companies are aware of their leverage and tend to deliver trial information that may read more like a persuasive packet than a scientific document.
Zantac is not the only drug to slip through one of these loopholes. Kaiser Health News found thousands of drug recalls are made each year. Most of them do not happen before the drug has been stocked in pharmacies and prescribed widely. Not all recalls are of the same severity, of course—some just require changes to packaging and/or marketing so consumers are fully aware of what the drug does and does not do. However, drugs that are removed from the market are sold for a median of 5 years before the FDA publishes a recall, according to the Physicians for a National Health Program. For drugs like Zantac that are far over the median, it’s hard to say how many people used the dangerous drug for enough time they might experience the effects.
The Cancer Hazards Facing Zantac (Ranitidine) Users
Though anyone who used Zantac for a short period is likely not at risk of NDMA-caused cancer, those who used the medication for chronic conditions may have been exposed to dangerous levels of the molecule. Unfortunately, there is no way to determine the amount of NDMA individual patients were exposed to because the decay of the medication was variable. However, lab tests have shown ranitidine could break down if it was:
- Exposed to environments that were room temperature or higher
- In contact with water
Higher temperatures increase the rate of decay, and the length of time between the drug’s manufacture and use also contributed to the variability in NDMA levels. This is why researchers are cautioning anyone who used the drug regularly. They could have been exposed to dangerous amounts of NDMA.
Theoretically, NDMA can be linked to most any kind of cancer. After ingested, it would enter the patient’s bloodstream and travel throughout the body. This molecule is dangerous because it can cause random DNA mutations. A change in the wrong base pair can be all that’s needed to start a cancerous growth. If you used Zantac or another ranitidine-based drug and then developed one of the following cancers, you may be eligible to sue:
- Multiple Myeloma
- Nasal Passage
- Non-Hodgkin’s Lymphoma
- Small Intestine
Even if you are not sure about the link between a cancer diagnosis and your history of Zantac use, come visit our firm. In a free consultation, we can help you understand and explore your legal options.
We Have Experience with Medical Law
Our team has won over $500 million for clients across the nation in the 27 years since Peterson & Associates, P.C. was founded. Over this time, we have built our experience with dangerous drug cases like those involving Zantac. It’s essential to have a knowledgeable team like ours behind you in a case like this.
Taking pharmaceutical companies to court isn’t easy—aside from the seemingly endless resources they put into cases, they will also come armed with complex scientific arguments. You need to be able to fight back on their level. Our team has a wide network of trusted medical professionals who can provide care and/or testify in support of your case. The first step in any dangerous drug claim we take is to learn the science completely so we can build a strong case for the client. Then, we will aggressively pursue compensation, even against a multinational corporation. We are not afraid to fight when justice is on the line.
Call our team at (816) 298-8708 or contact us to schedule a free case evaluation if you took Zantac for an extensive time and then developed cancer. Our defective drug attorneys can help you start a case.