Ranitidine contamination: FDA recommends more accurate NDMA test

  • FDA
  • 02.10.2019

  • von Craig Hicks
  • Clinical Essentials
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Takeaway

Why this matters

  • Results reported by 1 laboratory are based on a method the FDA recommends for assessing contamination in angiotensin II receptor blockers (ARBs); when applied to ranitidine, this method boosts NDMA levels and skews test results.

What manufacturers should do

  • The agency asks ranitidine manufacturers to test their products using the LC-HRMS method and to send product samples to FDA scientists for additional testing.

What FDA is doing

  • The FDA first alerted patients and providers to ranitidine-NDMA contamination in mid-September 2019, and by the end of that month had announced voluntary recalls of prescription capsules distributed to wholesalers and retail pharmacies, as well as over-the-counter tablets sold nationwide by Rite Aid, Walgreens, and Walmart stores.
  • The agency continues testing ranitidine products from multiple manufacturers and assessing potential risks to patients exposed to the drug; the agency will provide more information as it becomes available.