Australia's drug regulator has issued a warning about women taking popular over-the-counter anti-inflammatory drugs like Nurofen and Voltaren during early pregnancy due to increased risk of miscarriage.
The Therapeutic Goods Administration is already in talks with drug companies to ensure packaging labels contain warnings that include women who are trying to conceive but may not yet know they're pregnant.
![The drug regulator has proposed a new warning about taking anti-inflammatory drugs if you are planning a family.](/web/20161013200104im_/http://www.theage.com.au/content/dam/images/g/p/y/x/d/k/image.related.articleLeadwide.620x349.grzp2t.png/1476218814212.jpg)
Current warnings on packages only relate to women who already know they are pregnant and are not mandatory for products that target period pain.
"This is relevant, as the data suggests that the risk is greatest when the medicine is taken close to the time of conception," the TGA stated in a health advisory on Tuesday.
The moves come after a TGA review into non-steroidal anti-inflammatory drugs (NSAIDs) confirmed the link between the use of NSAIDs, with the exception of aspirin, and the increased risk of miscarriage.
Popular NSAIDs include ibuprofren, diclofenac, mefenamic acid and naproxen, commonly sold in Australia under the names Nurofen, Voltaren, Ponstan and Naprogesic.
In 2011, a large Canadian study of thousands of pregnant women found those taking NSAIDs were more than twice as likely to miscarry than those not taking the drugs. American researchers in 2003 had interviewed more than 1000 recently pregnant women and found that use of NSAIDs increased the risk of miscarriage by 80 per cent.
The TGA is working with pharmaceutical companies to implement three recommendations on the back of the review, which include harmonising warnings on products regarding the increased risk of miscarriage, and requiring period pain specific drugs to include the warning.
The Advisory Committee on the Safety of Medicines last year told the review that although the strength of evidence for a link between the drugs and miscarriage was weak overall, "the most robust study did suggest an increased risk associated with timing of exposure".
It also found that given the potential for large numbers of women to be exposed to the popular pain relief drugs, particularly those that are available other the counter, any small risk was "of public health significance".
But the committee advised that there was not sufficient evidence to change the current advice on the use of aspirin.
The TGA has proposed to replace warnings on all oral non-aspirin NSAIDs with: "Do not use if likely to become pregnant, or during the first six months of pregnancy except on doctor's advice. Do not use at all during the last three months of pregnancy."
The change would not be implemented until late 2018 if it passes consultation.
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Current TGA advice
Use of non-aspirin NSAIDs is known to be associated with an increase in the risk of miscarriage, particularly when taken close to the time of conception. There are many other individual factors that can increase the risk of miscarriage, including advanced age, smoking, obesity and other medical conditions.
If you are pregnant, think you may be pregnant or are trying to become pregnant, consult a health professional before using these products and consider using an alternative medicine.
If you use any over-the-counter medicine, always read the label and follow the instructions.
If you have any questions or concerns about this issue, talk to your health professional.