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Non-aspirin NSAIDs linked with miscarriage

By News team

Pregnant women have been advised by researchers to be cautious about using non-aspirin non-steroidal anti-inflammatory drugs, after research linked the drugs with a risk of miscarriage.

Published yesterday (6 September 2011) in the Canadian Medical Association Journal, the study suggests the use of non-aspirin NSAIDs during pregnancy more than doubles the risk of miscarriage compared with no use of the drugs (see Panel).

The study’s authors, from the University of Montreal, said: "We consistently saw that the risk of having a spontaneous abortion was associated with gestational use of diclofenac, naproxen, celecoxib, ibuprofen and rofecoxib alone or in combination, suggesting a class effect."

Prostaglandins are thought to play a role but the mechanism of action remains unclear, they say, calling for further research.

Jane Bass, consultant pharmacist in women’s health and pregnancy at Guy’s and St Thomas’ NHS Foundation Trust and the Royal Pharmaceutical Society’s spokeswoman for women’s health, said: "This study reinforces the message that women should be advised to avoid NSAIDs in pregnancy and that paracetamol is the safest analgesic to take at any stage of pregnancy."

She added: "The availability of general sale list and pharmacy packs means that the message to the general public as to which drugs are NSAIDs needs to be reinforced."

Limitations of the study included lack of data about over-the-counter non-aspirin NSAID use and information about the reasons women were taking the drugs.

Study method and results

The nested, case-controlled study compared the non-aspirin NSAID use of each of 4,705 women who had miscarried within 20 weeks’ gestation with that of ten randomly-assigned, pregnant control cases (n=47,050).

Controls were pregnant women who did not have a miscarriage at the same gestational age of their matched case, but who were at risk of having one and so had similar probabilities of being exposed to medication.

Exposure was defined as having filled at least one prescription for any type of non-aspirin NSAID during, or immediately before, pregnancy.

Use of the drugs during pregnancy was associated with an increased risk of miscarriage compared with no use (odds ratio 2.43, 95% confidence interval 2.12–2.79).

The highest risk was seen among women who used diclofenac (OR 3.09, CI 1.96–4.87) and the lowest with rofecoxib use (OR 1.83, CI 1.24–2.70). No dose-response relationship could be established.

Citation: The Pharmaceutical Journal URI: 11083639

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