Warning issued to women taking popular over-the-counter anti-inflammatory drugs like Nurofen and Voltaren during early pregnancy.
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, reports The Age.
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.
Popular NSAIDs include ibuprofren, diclofenac, mefenamic acid and naproxen, commonly sold in Australia under the names Nurofen, Voltaren, Ponstan and Naprogesic.
The incidence of spontaneous abortion for clinically recognised pregnancies up to 20 weeks gestation is considered to be 8-20%. The incidence of subclinical pregnancy is higher, ranging from 22-26% as found in studies that assessed daily urinary human chorionic gonadotrophin levels.
‘Data suggested a 5- to 7-fold increased risk of miscarriage in women taking NSAIDs around the time of conception.’
‘However, once pregnancy is established, or if pregnancy occurs despite their use, they can be continued into the second trimester (up to 32 weeks) as there are no data suggesting increased fetal malformations.’
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.
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.
We recently shared an article warning pregnant women who take paracetamol are more likely to have children with behavioural problems. Scientists found an association between mothers who took the drug in the first and third trimester of pregnancy and hyperactivity and emotional problems in their seven-year-old children.
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