FDA Committee Finds NSAID Study Unreliable

An advisory committee of the FDA has concluded that data from a meta-analysis study, which suggested that naproxen carries a lower cardiovascular risk than other nonsteroidal anti-inflammatory drugs (NSAIDs), is not reliable.

Furthermore, the advisory committee reviewed the 2005 FDA labeling rules that require NSAID pain medication to carry a heart warning. The panel voted (16-9) against allowing naproxen to change its label, saying the available data didn’t support the conclusion that naproxen was safer for the heart.
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The FDA does not have to follow the recommendations of the advisory committee, but generally does so.

The panel also addressed a secondary question on the labels of NSAIDS. Currently, the NSAID labels imply the risk of heart issues is not substantial when the drugs are taken for a short amount of time. The panel voted 14-11 that the labeling language should be reconsidered in light of new studies.

The Take-Home Message: Physicians need to be aware of all pain medications that their patients may be taking and account for the drugs from the start of therapy.

Reference:

1. Briefing document for US Food and Drug Administration Advisory Committee meeting. 2014 Jan 10. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM383181.pdf. Accessed Feb 12, 2014.