Since the recalls of products containing ranitidine began last year, the Food and Drug Administration, along with consumers here in Ohio and elsewhere, pharmaceutical companies and researchers have been asking why N-nitrosodimethylamine was found in unsafe concentrations in the popular heartburn medication. Now, there could finally be some clues as to why the Zantac debacle occurred. Emery Pharma’s initial reports may provide promising answers, which could ultimately reveal how to make the medication safe again.
Researchers at Emery Pharma believe that heat is the problem. During the manufacturing process, the medication does not reach significant heat levels, which keep the NDMA at a minimum. However, if the product is in an environment in which the heat rises to at least 158 degrees, the medication’s NDMA levels skyrocket.
This would mean that the manufacturing process does not create unsafe levels of the human carcinogen. Instead, the drug could produce higher levels of NDMA during transport where temperatures can rise on cargo ships and truck trailers. By the time the medications reach their destination, they could cause harm to consumers. Moreover, if a consumer leaves a bottle of ranitidine in a place where the temperature could rise to at least 158 degrees, such as inside a car in the summer, the drug will create the harmful chemical.
Emery Pharma has contacted the Food and Drug Administration, requesting a recall of all remaining ranitidine on the market. Researchers also recommend that any product manufactured from this point on ship under temperature-controlled conditions in order to help prevent the chemical reaction before the product reaches the consumer. Many heartburn sufferers here in Ohio and elsewhere would probably be glad to hear that the Zantac debacle may have a rather simple solution, but that does not erase the fact that many people ended up with cancer because no one took the time to do this same research before now.