More prescription-strength and hospital-used ranitidine, sold over the counter under the brand name Zantac, has been recalled for having too much of carcinogen NDMA. Though the run of recalls on the heartburn drug continues, FDA testing should calm some stomachs.
“Through our testing so far, we have found levels of NDMA in ranitidine that are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats,” wrote Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
According to results released by the FDA, most of the eight lots of 75mg Zantac tested as having NDMA within levels the FDA considers “reasonably safe for human ingestion based on lifetime exposure.”
That range is 0.32 parts per million (ppm) or 0.096 micrograms of NDMA per day. The 75mg Zantac tested 0.10 to 0.55 parts per million and 0.01 to 0.04 micrograms. The eight lots of 150mg Zantac tested at 0.07 to 2.38 ppm and 0.01 to 0.36 micrograms.
Brand name Zantac is made by Sanofi Pharmaceutical. Other companies make over-the-counter ranitidine sold under the company name or as store brands. The other OTC ranitidine tested, from Cardinal Health, came in at 1.02 ppm and 0.15 micrograms, both over the FDA’s limits.
“We also conducted tests that simulate what happens to ranitidine after it has been exposed to acid in the stomach with a normal diet and results of these tests indicate that NDMA is not formed through this process,” Woodcock continued. “Similarly, if ranitidine is exposed to a simulated small intestine environment, NDMA is not formed.
“However, we still must test the drugs in the human body to fully understand if ranitidine forms NDMA.”
One of the prescription drugs tested that came in over was Aurobindo’s 300mg capsules, part of this week’s recalls. Aurobindo recalled 21 batches of 150mg tablets and capsules, 13 batches of the 300mg capsules and four batches of 15mg/ml syrup. To check if your batch number was included, click here for the list.
American Health Packaging pulled its 150mg/10ml syrup made for hospital usage, lot Nos. 18373; 194278;187652; 177874; 178413; 183449; 184445; and 186563.
“In our testing of ranitidine syrup, primarily used in neonates and pediatric patients, some samples yielded levels of NDMA above the acceptable daily intake level in some lots,” Woodcock said. “Medicines with unacceptable levels are being recalled. We understand the concern we’ve been hearing from parents and pediatricians, and we’ll continue to investigate. Testing of ranitidine for injection is still ongoing.”
The FDA is also asking drug makers to recall nizatidine, also known as Axid, if it tests as having NDMA above the levels set for ranititidne. Patients taking prescription level drugs that have been recalled need to talk to their doctor about other options.