Online Pharmacy Stirs Ranitidine Controversy With Petition To Halt Sales
After its tests showed ranitidine forms a nitrosamine impurity that is a probable carcinogen, Valisure asks FDA to suspend sales of antacid products containing the API. In citizen petition firm, online pharmacy also advises FDA to publish regulations requiring independent chemical testing, verification of drugs.
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FDA should recall dozens of hand sanitizers found to contain benzene, a known human carcinogen, says Valisure, the compounding pharmacy that raised initial alarm about ranitidine in OTC heartburn drugs, leading eventually to withdrawals of the products.
Sedgwick reported US OTC drug recalls in 2020 doubled to 61 driven by methanol contamination and GMP deviations in hand sanitizers. Once FDA resumes full inspection schedule, enforcement will be “more frequent, penalties will be harsher and cross-agency collaboration” will be welcome.
JAMA study found under simulated gastric conditions a standard tablet of ranitidine yielded NDMA to three orders of magnitude beyond established exposure limits. Rapid formation of NDMA appears to continue for extended periods in gastric conditions, say researchers from Memorial Sloan Kettering and Valisure.