EMA Set To Discuss Safety Of Ranitidine
Follows US Announcement That Zantac And Generics Must Be Withdrawn
Following the announcement in the US that ranitidine drugs must be withdrawn from the market, the European Medicines Agency told the Pink Sheet it would decide on the fate of these medicines in the EU after wrapping up its own inquiry.
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EU Suspends Ranitidine Medicines
In addition to deciding to suspend ranitidine-containing medicines, the European Medicines Agency has issued recommendations on testing patients for DPD deficiency before they are treated with fluorouracil or related medicines.
Why The US FDA Requested Ranitidine Withdrawal; How Other Withdrawals Could Follow
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.
US FDA Requests Ranitidine Removals
FDA requests immediate removal of ranitidine OTC and Rx drugs after third-party testing finds contaminant NDMA increases during storage, especially at higher temperatures. CDER Director Janet Woodcock asks firms to reformulate products to be stable as the ingredient remains approved.