A second lab is pushing the U.S. Food & Drug Administration (FDA) to remove Zantac and all other ranitidine-containing heartburn drugs from the market, after new testing suggested a potentially cancer-causing contaminant can form while the medications are being stored.
The online pharmacy Valisure first petitioned the FDA for a Zantac recall in September, reporting that its testing had detected excessive levels of N-Nitrosodimethylamine (NDMA) – a probable human carcinogen –in every sample of ranitidine it tested. The company asserts that the contamination resulted from the instability of the ranitidine molecule, which purportedly degrades when subjected to conditions that mimic human digestion.
So far, the FDA has declined to recall any Zantac or ranitidine products, even while admitting that its own testing detected NDMA at levels that ranged from safe to dangerously high. However, a growing number of drug makers have announced voluntary Zantac recalls and various retailers have opted to remove all ranitidine-containing antacids from their store shelves.
Last week, California-based Emery Pharma filed a second Zantac recall petition with the FDA, after its own round of testing found that ranitidine appears to produce unacceptably high levels of NDMA when exposed to heat for as little as five days, even after the drug has been packaged.
“Our preliminary data indicate that NDMA accumulates in ranitidine-containing drug products on
exposure to elevated temperatures, which would be routinely reached during shipment and during storage,” the company’s petition states. “More importantly, these conditions occur post-lot release by the manufacturer. Hence, while NDMA levels in ranitidine may be acceptable at the source, they may not be so when the drug is purchased and subsequently at the time of consumption by the consumer.”
Emery is asking that the FDA suspend all Zantac and ranitidine sales, recall all such products already on the market, and require stability testing before they can be sold in the future.
“Manufacturers should have a strong warning on the label that if the product has been heated above a certain temperature, they shouldn’t use it,” Emery CEO Ron Najafi said in a telephone interview with Bloomberg News. “Or else you may be exposing yourself to large quantities of this cancer-causing agent.”
An FDA spokesperson declined to comment on the substance of Emery’s petition, but told Bloomberg hat the agency would review the request and respond directly to the company. In the meantime, the FDA is continuing its Zantac investigation and has asked manufacturers to test all lots of the medication, inform the agency if any are found to contain more than 96 nanograms of NDMA, and ensure they are not put on the market.
The FDA has also advised consumers using over-the-counter Zantac and other ranitidine-containing drugs to consider switching to an alternative heart burn treatment. However, those taking prescription versions should not stop treatment without first talking with their doctor, as doing so could greatly worsen their condition.
More than a dozen Zantac cancer lawsuits have been filed in U.S. courts since the FDA launched its investigation in September. However, legal experts believe the litigation will eventually grow to include hundreds of similar claims. On January 30th, the U.S. Judicial Panel on Multidistrict Litigation (JPML) will hear oral arguments on a proposal to centralize all such federal lawsuits in a single jurisdiction for coordinated discovery and other pretrial proceedings.