On April 1, 2020, the U.S. Food & Drug Administration (FDA) requested that manufacturers withdraw ALL prescription and over-the-counter ranitidine drugs immediately. Here is how the FDA began its announcement:
The U.S. Food and Drug Administration today announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.
What is ranitidine? You may know this medication as Zantac, its brand name.
What is Ranitidine?
Zantac was introduced to patients in the early 1980s. The drug soon became a blockbuster, best-selling antacid drug. By 1986, Zantac reached $1 Billion in sales. By 1988, Zantac became the world’s best-selling blockbuster medication.
For decades, Ranitidine has continued to be one of the world’s most popular medications. Ranitidine works by decreasing the amount of acid produced in the patient’s stomach.
Zantac became available without a prescription in 1996. Other drug makers quickly entered the market. Prescription-strength Zantac remained available for patients with problems including severe heartburn or stomach ulcers. In America, the demand for antacids is especially high.
Why Is Ranitidine Harmful?
To understand how and why ranitidine is harmful, you need to be familiar with the chemical NDMA. NDMA is a N-nitrosamine and is an unstable organic chemical. It is carcinogenic.
Many years ago, NDMA was commercially produced for use making rocket fuel. Now, it is only produced commercially for purposes of scientific research.
The research is overwhelming. The Environmental Protection Agency (EPA) classifies NDMA as a probable human carcinogen. The Center for Disease Control (CDC) notes the cancer-risks of NDMA even at low dosages. In its April 2020 announcement, the FDA specifically stated:
NDMA is a probable human carcinogen (a substance that could cause cancer).
How do we get from ranitidine to the carcinogen NDMA? NDMA is a byproduct of the ranitidine molecule itself. That is, NDMA in pills may increase as the medicine ages or undergoes chemical reactions.
Research indicates ranitidine interacts with nitrites and acids in the human stomach to form NDMA as a byproduct. Research also indicates ranitidine interacts with enzymes in other human organs to create NDMA as a byproduct. In other words, research indicates NDMA is created in the human body as a byproduct of normal ranitidine use.
Research indicates NDMA is a probable human carcinogen for multiple cancers. These cancers include:
More and more studies are linking NDMA exposure to specific cancers. We are continuing to gather and study the research related to NDMA and cancers.
How Are Zantac Cancer Claims Proceeding?
A growing number of Zantac cancer injury cases are being filed across the United States. In February 2020, the number of common cases reached the point that all pending Federal Court cases were consolidated for pre-trial purposes. That means a single judge will oversee all pre-trial issues and discovery involving Zantac cancer cases.
The process of consolidating large numbers of defective drug and device cases is commonly referred to as multi-district litigation (or MDL). Federal Courts will often assign a specific judge to handle pre-trial and discovery issues. The idea is that a single judge aids efficiency and consistency. Individual claims that do not settle are eventually returned to the Federal Court in the geographic area where originally filed for trial.
In past years, we have actively been involved in other MDL cases. We have worked other MDL cases, including developing experts, working with treating doctors, and preparing for trial.
A Few Final Words
We are looking closely at Zantac cancer injury claims in Alabama. Like other bad drug and medical device claims, I believe injured consumers need a lawyer who is experienced in all the following: (1) appearing before Federal Courts across the US in these cases; (2) developing key medical and scientific evidence; and, (3) working with local physicians who actually examined and treated the injured person. We have worked on numerous multi-district injury cases for our Alabama clients.
If you have questions, let us know. We are happy to provide answers. If you want to read more, I would recommend reading the full Zantac article I wrote and published on the Hot Topics section of our law firm website: Hot Topics — Zantac Cancer Lawsuits.
From its office in Huntsville, the Blackwell Law Firm handles serious personal injury cases across Alabama. Consultations are always free and confidential.