NSAIDs and the Risk of Miscarriage

08 September 2011

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The Australian Self-Medication Industry (ASMI) today commented on a nested case-control study published in the Canadian Medical Association Journal1. The study included 4,705 women who had experienced a spontaneous abortion and 47,050 matched controls.

The authors of the study found that the use of nonaspirin NSAIDs taken during early pregnancy was associated with a statistically significant risk (2.4 fold increase) of having a miscarriage and concluded that nonaspirin NSAIDs should be used with caution during pregnancy.

ASMI Regulatory and Scientific Affairs Director, Steven Scarff noted that the risks associated with NSAID use during pregnancy were already known and that over the counter NSAIDs available in Australia (such as diclofenac, ibuprofen and naproxen) already carried mandatory label warnings as a result. These warnings instruct consumers that the products are only to be used in the first six months of pregnancy on a doctor's advice, and that the products were not to be used at all during the last three months of pregnancy.

Although the study had some limitations, it provides additional information about a known topic and will be of use to healthcare professionals in assessing the risks and benefits of NSAID use during pregnancy.

Mr Scarff noted that the case-control design of the study meant that although the authors found the association described above, they were unable to show a cause and effect relationship between the use of nonaspirin NSAIDs and miscarriage. Also the exposure data in the study was based on filled prescriptions rather than actual medication use.

Despite this, the study provides an opportunity to remind consumers that NSAIDs, like all other medicines, should only be used during pregnancy on the advice of a healthcare professional.

Consumers should always read the label carefully and follow the directions and warnings. Significant care has been taken with the labelling of these medications and it is important that consumers follow the instructions.
Consumers should discuss their use of NSAIDs with their doctor or pharmacist if they have any concerns.

Over the counter NSAIDs are safe and effective for the temporary relief of pain and inflammation.
About ASMI: The Australian Self-Medication Industry (ASMI) is the peak industry body for the Australian self care industry representing consumer healthcare products including over-the-counter medicines and complementary medicines. ASMI's mission is to promote better health through responsible self-care. This means ensuring that safe and effective self-care products are readily available to all Australians at a reasonable cost. ASMI works to encourage responsible use by consumers and an increasing role for cost-effective self-medication products as part of the broad national health strategy. www.asmi.com.au

Media contact: Bob Bowden, Foresight Communications (02) 9241 2811, 0412 753 298

1 Nakhai-Pour HR et al. Use of nonaspirin nonsteroidal anti-inflammatory drugs during pregnancy and the risk of spontaneous abortion. CMAJ September 6, 2011 cmaj.110454; published ahead of print September 6, 2011, doi:10.1503/cmaj.110454