FDA And EMA Evaluate Claims As Nitrosamine Worries Turn To Zantac
Pharmacy petitions for recalls after finding ‘inherent instability’ in antacid that could pose carcinogenic risk.
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Agency worried what might happen beyond expiry or room temperature to generate carcinogenic impurities in ranitidine; will guide assessment of nitrosamine risks in other drugs.
EU regulators say that sponsors must complete their nitrosamine-related risk evaluations for all EU medicines containing chemically-synthesised active substances within the six-month timeframe.
Ranitidine no more carcinogenic than grilled meat, says FDA drug center director Janet Woodcock. Agency finds NDMA levels in ranitidine drugs well below those claimed by Valisure, online pharmacy asking FDA to order drug off US market.