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# Panel Shoots Down Pfizer Arthritis Drug REMS
- URL: https://www.fdaweb.com/panel-shoots-down-pfizer-arthritis-drug-rems/
- Published: 2021-03-25T12:00:00.000Z
- Updated: 2026-09-14T16:52:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148974

A 3/25 FDA advisory committee voted 19 to 1 that a Pfizer-proposed Risk Evaluation and Mitigation Strategy (REMS) in its BLA for osteoarthritis drug tanezumab subcutaneous injection does not ensure that the drug’s benefits outweigh its risks. FDA reviewers told panel members that the REMS was not sufficient to mitigate joint risks. They also noted that discontinuing the drug after patients develop joint damage “does not appear to be effective in preventing further damage to the joints.”  

In a [briefing document](https://www.fda.gov/media/146867/download?ref=fdaweb.com) released in advance of the meeting, agency reviewers said superior efficacy was not demonstrated over non-steroidal anti-inflammatory drugs (NSAIDs), and two serious toxicities — joint destruction and neuropathy — caused by tanezumab have been identified. Reviewers further said the “trajectory of incidence of joint events in patients with more than one year of treatment is unknown. Most of the joint safety events were detected towards the end of the treatment and during the follow-up period after the cessation of treatment.”