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TGA Consults on NSAID Label Changes

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November 9, 2016

Australia’s Therapeutic Goods Administration (TGA) has started a public consultation on its proposed changes to the labels of non-steroidal anti-inflammatory drugs (NSAIDs) to reflect miscarriage risk.

The change specifically adds a line stating NSAIDs must not be used by women who are “likely to become pregnant.” The current labeling requirement for ibuprofen and other NSAIDs states that these drugs should not be used in the first six months of pregnancy, unless it was advised by a doctor.

Comments may be submitted until November 22, 2016.

Source URL: Consultation: Non-steroidal anti-inflammatory drugs: proposed additional advisory statement