Ranitidine and the issues
Ranitidine is an acid-suppressant medicine that has been widely used. If you have been prescribed ranitidine previously, then you may be aware that it is currently unavailable in the United States. All ranitidine products have been discontinued until further notice due to contamination with a substance called N-Nitrosodimethylamine (NDMA). NDMA is a substance that is thought to cause cancer. It is found in very low amounts in foods, including roasted meats, cheese and beer and is safe to ingest at low levels. Studies are investigating whether NDMA has been produced from the breakdown of ranitidine and if this happens inside the body.
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Is it discontinued forever?
If findings show that ranitidine forms NDMA, chances are that it may be permanently discontinued due to safety concerns. Otherwise, more significant restrictions to license may be made (e.g., stricter storage conditions or shorter shelf life of product or reformulation to maintain stability). In the meantime, other alternatives can be used to treat the same conditions as ranitidine, which are widely available and safe to take.
I used to take ranitidine; should I be worried?
NDMA ingestion below 96 nanograms a day is considered within safe levels. Any levels above are therefore considered an unacceptable risk. The levels of NDMA found in ranitidine are around the same as you would see from smoked and grilled meats. You would need to take it every day for many years to have a very low chance of developing cancer. While the investigations are ongoing, the FDA estimated the risk is likely to be similar to another drug, valsartan, which in the past had concerns regarding NDMA contamination.
The estimate is that if 8,000 people took the highest dose of valsartan-containing NDMA every day for four years, there would be one additional case of cancer over the lifetimes of these 8,000 people.
What are the alternatives?
There are other medicines in the same class as ranitidine, like famotidine and cimetidine, which have not been linked to NDMA. Different types of medication, like proton pump inhibitors (e.g., omeprazole and lansoprazole), are also used to treat stomach acid, ulcers and indigestion. These are currently available on the market and safe to take. Speak to your doctor to advise on the best course of action.
The future of ranitidine and patient safety
The future of ranitidine remains uncertain as investigations into NDMA contamination continue. Patient safety is of utmost importance, and regulatory bodies are closely monitoring the situation to ensure appropriate measures are taken. If ranitidine is found to form NDMA, it may face discontinuation or stricter restrictions on its use. In the meantime, it is crucial for individuals who previously took ranitidine to stay informed and consult their healthcare providers for alternative options. Other medications within the same class as ranitidine, such as famotidine and cimetidine, can be considered as alternatives, along with different types of medication used to treat stomach acid and related conditions. Open communication with healthcare professionals will help guide patients towards the most suitable and safe treatment choices for their specific needs.
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