The National Medical Products Administration (NMPA) has released 10 notifications regarding revisions to package inserts for 11 drug varieties, impacting 47 products in total. The updates include changes to sections on adverse reactions, contraindications, and precautions. Marketing Authorization Holders (MAHs) are mandated to update the package inserts and labels within nine months after the regulatory filing.
Drug Varieties Affected and Manufacturer Impact
The varieties involved in the revisions are Jinwugutong capsule, total glucosides of peony, adenosine cyclophosphate, tofacitinib, diisopropylamine, Zhuanggu Zhitong capsule, piracetam, XiaoErKeChuanLing, meglumine diatrizoate, ribavirin, and human interleukin-11, affecting over 100 manufacturers. The majority of these revisions are necessitated by post-market detection of adverse reactions or related events, with some modifications informed by news or literature reports.
Specific Revisions and Black Box Warnings
Piracetam, for instance, has seen new content added regarding its use in pregnant and lactating women, children, the elderly, and in relation to drug interactions. Notably, ribavirin and tofacitinib have had black box warnings added to their labels. These warnings highlight serious and potentially life-threatening risks associated with the use of these medications.-Fineline Info & Tech
