According to the World Health Organization, exposure to high levels of NDMA can cause cancer, including gastric or colorectal cancers. NDMA can also cause severe liver damage and internal bleeding. NDMA can harm the liver even if an individual is only exposed to the substance in small amounts.
Common Reasons for Exposure to NDMA
Nitrosamines, such as NDMA, are carcinogens that can be found in grilled and cured meats, vegetables, dairy products, and water, according to the U.S. Food and Drug Administration. The FDA reported that the low levels of NDMA found in food and water are not thought to increase people’s risk of developing cancer.
Some medications have nitrosamines. They may be present because of a drug’s chemical structure, the process used to manufacture it, or the packaging and storage conditions of the medication. The human body can also form nitrosamines as it processes food and drugs. People with exposure to levels of nitrosamines that exceed acceptable limits over a long period of time may have an increased risk of developing cancer.
NDMA has been found in Zantac, a histamine-2 blocker that goes by the generic name of ranitidine. That class of medications reduces the amount of acid produced in the stomach and treats conditions such as ulcers and gastroesophageal reflux disease, or GERD.
The U.S. Food and Drug Administration is working to identify the source of NDMA in ranitidine. The FDA found NDMA in both finished Zantac and the active pharmaceutical ingredients used to manufacture it. When the FDA performed tests to simulate conditions in the human digestive system, it found that NDMA was not produced when Zantac was broken down in the body. According to a report from USA Today, it appears that NDMA is found in Zantac because of the drug’s “unstable nature,” not the manufacturing process.
The U.S. Food and Drug Administration has worked with other organizations to set internationally-recognized standards for acceptable daily limits for nitrosamine intake. Individuals who take Zantac may unknowingly be exposed to unsafe levels of the carcinogen.
The amount of NDMA in ranitidine can increase if the medication is exposed to high temperatures, which can occur while it is being transported or while it is in storage. According to the U.S. Food and Drug Administration, its testing confirmed that levels of NDMA in ranitidine can increase significantly at higher temperatures. The amount of NDMA in Zantac may also rise due to the passage of time under normal storage conditions
Steps by the FDA to Protect the Public From NDMA in Zantac
In April 2020, the FDA asked manufacturers to immediately withdraw all prescription and over-the-counter forms of ranitidine from the market. Although the FDA did not detect unacceptable levels of NDMA in samples of Zantac it tested, it was concerned that levels could rise due to storage conditions and could endanger consumers.
The FDA recommended that people who were taking over-the-counter ranitidine stop taking it, dispose of any medication they had left, and take a different over-the-counter drug that did not contain NDMA. Patients who were taking prescription Zantac were advised to ask their doctor if they should continue taking it or switch to a different medication.
How Unsafe Medications Receive Approval in the First Place
People take medications assuming that they are safe, but in many cases that is not true. Drugs that have been prescribed or sold over the counter for years or decades are sometimes later found to be unsafe. Some even cause life-threatening medical problems.
The U.S. Food and Drug Administration may give in to pressure from pharmaceutical companies that want to quickly bring new drugs to market. If thorough medication research to make sure they are safe, unsuspecting members of the public may be exposed to drugs that can put their health in jeopardy.
What to Do If You Believe NDMA in Zantac Is Responsible for Your Injuries
Pintas & Mullins Law Firm handles cases for different types of personal injuries, including unsafe medications. If you believe that NDMA caused your cancer, you have the right to seek financial justice. If you seek representations from a member of our team, we will fight for compensation for economic and noneconomic damages, such as medical expenses and emotional distress.
Although you do not need a lawyer if you want compensation for your injuries, hiring an attorney can offer peace of mind as members of our team handle the various aspects of the case. You may find the legal process overwhelming and confusing, but you can hire a lawyer so you can focus on your health.
Our firm works on a contingency basis. That means that if you hire us to represent you, you will not have to pay us anything up front. We will only receive a fee if we secure a financial settlement for your injuries. Call our office at (800) 635-1144 to talk to a member of our staff about what you have experienced and to explore your legal options.