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Lotronex REMS’ Verification Process Should Be Electronic, FDA Panel Says

 
• By Sue Sutter

Drug Safety and Risk Management Advisory Committee overwhelmingly favors elimination of paper-based sticker system to verify prescriber enrollment and documentation of safe use conditions under Prometheus’ REMS for the irritable bowel syndrome drug.

The Risk Evaluation and Mitigation Strategy for Prometheus Laboratories Inc.’s irritable bowel syndrome drug Lotronex (alosetron) should retain elements to assure safe use (ETASU) restrictions but shift to an electronic verification system at the point of dispensing, FDA’s Drug Safety and Risk Management Advisory Committee said July 10.

Thirteen of 18 panelists voted to update the current REMS to include integration of e-pharmacy management systems to verify prescriber...

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