Zantac will be back on the market when the manufacturer, Sanofi, can confirm to the U.S. Food and Drug Administration (FDA) that the NDMA levels in the drug are stable and do not pose a threat to consumers. Only then will the FDA “consider” making Zantac and other ranitidine products available.
The FDA recently issued a recall for ranitidine, the active ingredient of histamine blockers such as Zantac that are used to treat stomach ulcers and acid reflux. If the stomach produces too much acid, it can make its way up the esophagus, causing irritation, inflammation, and ulcers. Excess acidity in the stomach can also eat away at the lining of the stomach, causing stomach ulcers and leading to bowel issues.
However, due to the FDA’s recall, Zantac is not expected to be back on the market until further testing confirms its safety.
Why Zantac Was Recalled
Lab tests have shown that, over time, ranitidine may lead to unacceptably high levels of NDMA in the body. According to the Mayo Clinic, NDMA is a toxic chemical that occurs in small amounts in nature. However, ranitidine can contain well above the safe daily intake level of 96 nanograms of NDMA.
The FDA recalled all ranitidine products because the NDMA level in ranitidine can increase over time and if it is stored in higher temperatures than room temperature. This might make the drug dangerous when taken very often, or for a long time.
Zantac will only be back on the market if the manufacturer can show, using scientific testing data, that it is safe and stable. The manufacturer must also conclusively prove that NDMA levels in the ranitidine that is used in Zantac do not increase to unsafe levels at different temperatures or for any other reasons. If there are any links to NDMA contamination of Zantac at overseas suppliers, those issues must be addressed as well.
For now, anyone who used Zantac or ranitidine products will not be able to buy it until the FDA reapproves it once more–if it reapproves it at all–and reaffirms it is safe for public consumption. In the meantime, you can take other acid reflux drugs that the FDA has deemed safe.
Why Zantac Was Not Recalled Earlier
Some people may wonder why Zantac was not recalled sooner if it contained, was thought to contain, or was thought to produce harmful toxins in the body. The answer to this is that drug manufacturers and the FDA itself both learn new things about chemicals and drugs and how they work over time.
Advancements in medicine also shed new light on the action of drugs and medications in the body. Better and more sophisticated testing allows the FDA to test drugs for issues that were not identified in the past.
How the FDA Handles NDMA Contaminants
The FDA, working with drug manufacturers, regularly assesses the quality and standards of pharmacological agents on the market to make sure they comply to set safety and effectiveness standards. A recent slew of drug recalls as a result of NDMA contamination may not indicate new issues with drug production.
Thanks to better and more effective testing, the FDA is better able to identify and trace toxins in medicines that are available to the public, and it can take remedial action as needed.
Important Next Steps
If you took it in the past, Zantac will not be back on the market anytime soon, but there are alternatives you can use if you suffer from heartburn, indigestion, stomach ulcers, or acid reflux. Speak to your doctor to discuss your options.
You should also make sure to speak with your doctor if you notice any changes in your health or suffer from vomiting, nausea, jaundice, abdominal pain, or notice blood in your stool or urine.
These symptoms may indicate NDMA poisoning and can also indicate cancer. Your past use of Zantac, your predisposition to NDMA poisoning, your occupation, and other factors can be used to determine whether or not you likely ingested enough NDMA to become sick from it.
Finally, you can also consult an attorney. The care costs for the symptoms of NDMA poisoning can be substantial, and cancer treatments are prohibitively expensive as well. If your health ailments were caused by a product manufacturer, you might have grounds for a product liability claim. Contact a member of the Pintas & Mullins Law Firm team at (800) 794-0444 to discuss your case.