After months of testing common heartburn drugs, the FDA said Nov. 1 that the levels of a cancer-causing substance in ranitidine products that prompted several recalls was no higher than what is found in common foods like grilled or smoked meats.
The agency first warned that some common heartburn drugs containing the active ingredient ranitidine may contain a possible carcinogen, called N-nitrosodimethylamine, in September.
Since then, the agency has conducted tests to simulate what happens to ranitidine after it is exposed to stomach acid with a normal diet and the results showed that no NDMA was formed. The agency also tested what happens if ranitidine is exposed to a simulated small intestine environment, and found no NDMA was formed.
"However, we still must test the drugs in the human body to fully understand if ranitidine forms NDMA," Janet Woodcock, MD, the director of the FDA's center for drug evaluation and research, wrote in a statement.
Dr. Woodcock added that although the NDMA levels found in the FDA's testing were significantly lower than what some third-party scientists found, some products did have an NDMA level above what the agency considers acceptable.
The agency said it still encourages drugmakers to test their ranitidine products and to send samples to the FDA for testing. If drugmakers or the FDA find an unacceptable level of NDMA, the FDA asks that the drugmaker voluntarily recall the product.
The FDA also asks drugmakers that manufacture nizatidine products, commonly known as Axid, to test and voluntarily recall their products if NDMA is found, as the chemical is similar to ranitidine.
The FDA did not find NDMA in common alternatives to ranitidine, such as Pepcid, Prilosec, or Nexium.
The agency also said it tested ranitidine syrup, which is used mainly for neonates and pediatric patients, and found some levels of NDMA higher than the acceptable amount, and some ranitidine syrups are being recalled.
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