Australia Plans Stronger Warning Labels for NSAIDs

Tuesday, February 17, 2015

Source: FDA News

Australian regulators are calling for labels on six types of nonsteroidal anti-inflammatory drugs to include strong warnings about cardiovascular and liver risks associated with excessive or prolonged use.

Labeling for flurbiprofen, ibuprofen, ketoprofen, mefenamic acid and naproxen would have to state that using the drugs increases the risk of heart attack or stroke. Makers of diclofenac would need to include that warning as well as a warning about possible liver damage, according to a consultation published by the Therapeutic Goods Administration.

The agency is seeking comments on proposed wording for the warnings, to be included in the next update of Required Advisory Statements for Medicine Labels. The TGA also wants to know how the proposed changes would impact the industry. Sponsors would have 12 months to amend their labels.

Last October, the TGA sought feedback on proposed actions arising from safety reviews on NSAIDs, including diclofenac, naproxen and ibuprofen. Those comments generally supported the need for additional cardiovascular safety statements, as well as liver safety statements for diclofenac.

The RASML already includes statements warning users of all six NSAIDs not to take them for more than a few days at a time unless under doctor’s orders, not to exceed the recommended dose and that excessive use may be harmful.

A new edition of the manual, due to take effect Dec. 12, will add statements warning users not to take these drugs if they have impaired kidney function or heart failure.

View All News »