Why you should warn women about non-aspirin NSAIDS
Women need to be told of the association between non-aspirin NSAIDs and spontaneous abortion when they’re pregnant or planning pregnancy, says the TGA.
The regulator says a review of the medical literature shows that on balance the epidemiological data supports a link, particularly when the drug is taken close to the time of conception.
In a safety review report released on Tuesday, the TGA says all OTC non-aspirin NSAIDs, including those exclusively indicated for dysmenorrhoea, should include an advisory statement on their packaging about the miscarriage risk.
There is insufficient evidence to support a causal association between aspirin use and miscarriage, the regulator says.
The TGA wants to see standardised PI warnings for systemic and ophthalmic non-aspirin NSAIDs as currently only five of the drugs - ibuprofen, mefenamic acid, piroxicam, celecoxib, and parecoxib – include a