On April 1, 2020, the Food and Drug Administration (FDA) issued a nationwide recall on many over-the-counter (OTC) brands of ranitidine drugs such as Zantac. These drugs are commonly used to treat ulcers, heartburn and gastroesophageal reflux disease (GERD). The decision to recall them comes after determining consumers using these products may be exposed to extreme levels of the impurity nitrosodimethylamine (NDMA), which can lead to serious health risks including liver damage and cancer.
What is NDMA?
NDMA (not to be confused with the illegal party drug MDMA) is an environmental impurity that the human body can tolerate low amounts of without causing any damage. The impurity can be found in foods such as dairy, meat and vegetables, all of which are tested by the FDA to ensure that the amounts we are exposed to are low enough to be tolerated easily.
However, NDMA can be extremely toxic to the liver, and is known to be a “probable human carcinogen” (a substance highly likely to cause cancer) when consumed or exposed to higher levels of the chemical.
The End of a Lengthy FDA Investigation
In September, the FDA reported finding low doses of NDMA in many ranitidine products. Their initial laboratory tests did not find high enough levels of the substance to be seen as harmful.
However, more recent laboratory tests have shown storing or distributing ranitidine products under certain conditions can raise the levels of NDMA in these drugs to dangerous levels.
Conditions That Raise NDMA Levels in Ranitidine Drugs
- The longer Zantac and other ranitidine drugs are stored, the higher the level of NDMA you will be exposed to when consumed. People that have had Zantac-type medications in storage for long periods of time due to being no longer needed or wanted are at greater risk of being exposed to dangerous levels of NDMA, should they decide to consume these drugs at a later date.
- Higher temperatures increase the amount of NDMA found in ranitidine drugs. This means that ranitidine products that are stored or distributed in high temperature conditions place consumers at greater risk of harmful NDMA exposure.
What to Do if You are Currently Taking Zantac or Another Ranitidine Product
If you are currently taking a ranitidine prescription, the FDA recommends you take the following steps immediately to ensure the safety and wellness of you and your community:
Step 1: Consult with Your Doctor
Before you stop taking your medication, consult with your doctor, and ask for an alternative prescription that does not put you at risk of being exposed to high levels of NDMA.
The FDA recall includes a ban on all future prescriptions of Zantac and other harmful ranitidine medications. Fortunately, there are many safe alternatives available that may help you just as much as your current Zantac or other ranitidine prescription. Safe alternatives available now include:
- Pepcid (famotidine)
- Tagamet (cimetidine)
- Nexium (esomeprazole)
- Prevacid (lansoprazole)
- Prilosec (omeprazole)
Ask your doctor which ranitidine alternative is best for you.
Step 2: Stop Taking Your Current Ranitidine Product Immediately
To minimize your risk of being exposed to dangerous levels of NDMA, it is recommended that you immediately stop taking any OTC ranitidine drugs immediately after consulting with your doctor.
Step 3: Dispose of Your Ranitidine Product Properly
When disposing of a drug such as Zantac, it is crucial that you dispose of it in a way that is safe, legal, and harmless to your community.
The best way to dispose of Zantac and other similar ranitidine medications is through a Drug Take-Back Event. These events are hosted by the DEA to aid people in safely disposing their unwanted, expired or harmful medications. The best way to find out if an event is happening near you is to ask your local pharmacist.
If a Drug Take-Back Event is not occurring in your community, the best way to dispose of Zantac according to the FDA is to mix–DO NOT CRUSH–the pills with another unpalatable substance (think cat litter, or used coffee grounds), seal them in a sealed plastic bag, and toss it in the trash.
The FDA warns that flushing the pills down the sink or toilet can be extremely harmful to your town’s water supply, and could wind up exposing lives in your community to harmful chemicals. Do NOT flush Zantac or other ranitidine drugs, and keep your community safe.
If You Wish to Take Legal Action
If you or a loved one are taking Zantac or another ranitidine medication, and are experiencing symptoms regarding liver damage or cancer, then you may be eligible to file a lawsuit to help pay for any related damages.
If you live in New York’s Greater Hudson Valley area or the Bronx, call 845-468-7626 for a free consultation with an expert Defective Drugs Lawyer at Sobo & Sobo. The team at Sobo & Sobo has helped people who were harmed by defective drugs and household chemicals for over 50 years, from carcinogenic products including Roundup and talcum powder, to recalled hernia mesh devices.