Consistent information in product information and on OTC product labels are needed to clearly communicate the increased risk of miscarriage associated with all non-aspirin NSAIDs, a TGA review has concluded.
The Pharmacovigilance and Special Access Branch found that the risk of miscarriage is discussed in Australian PI for only five of 14 non-aspirin NSAID molecules.
Most of the products without warnings in Australia had cautionary statements included in some international PI documents.
It recommended that the increased risk should be specifically included in the PIs for all systemic and ophthalmic preparations of non-aspirin NSAIDs.
Warnings on labels for over-the-counter NSAIDs state that the product should not be used except during the first 6 months of pregnancy except on a doctor’s advice, and not at all during the last 3 months of pregnancy.
“This advisory statement does not address the use in women who have just conceived and are therefore unlikely to be aware that they are pregnant,” the review stated.
“The increased risk of miscarriage with non-aspirin NSAID use suggests that the risk is greatest when…taken at the time of conception.”
Clearer statements about the risks are needed, it said. It would also be helpful if all product labels said they should not be used “if pregnant or likely to become pregnant”.
These steps, backed up by continuing education of health professionals and consumers, would allow the risk to be adequately communicated to patients and facilitate an individual benefit-risk assessment.
The review noted that products labelled as being for dysmenorrhoea are, paradoxically, not currently required to carry warnings about use in pregnancy.
“It is possible that a woman planning to become pregnant, who has conceived but is not yet aware of the pregnancy, may pre-emptively take non-aspirin NSAIDs indicated exclusively for dysmenorrhoea and not be cautioned about the use during pregnancy,” the review said.
The review did not detail the extent of the risks associated with NSAID, but said it was a well-accepted relationship and “on balance” the epidemiological data supported a link with spontaneous abortion.
Aspirin, given its very long history pre-dating rigorous pharmaceutical regulation, has no approved PI at all, except when in combination with clopidogrel or dipyridamole. The review said there is insufficient evidence to support a causal role for aspirin in miscarriage.