TGA Warns of Miscarriage Risk with Over The Counter Medications

Therapeutic Goods Administration (TGA) is working towards all Pharmaceutical drug companies replacing the warnings on some their packaging to warn of the increase miscarriage risk.

TGA says that most Non -Steroidal Anti Inflammatory Drugs (NSAID’s) have warnings for use throughout pregnancy but not for those women who are trying to conceive but might not know they are pregnant, because it is not yet mandatory to alert women taking the medications.

Medications; Ibruprofen, Diclofenac, mefenamic Acid and Naproxen are popular over the counter medications taken to treat period pain. The more well-known names of Voltaren, Naprogesic and Nurofen are all made up of these drugs. All NSAID’s, excluding Aspirin are known to increase a woman’s risk of having a miscarriage but up to 80% says and American study of 1000 women.

A more recent study in Canada reviewed thousands of women and the outcome said that NSAID’s make them twice as likely to miscarry.

Therapeutic Goods Administration is working extremely hard with drug companies making these medications to make sure they are all compliant with three new warnings on their packaging including  the need to add a warning regarding the miscarriage risk.

Advisory committee on Safety Net of Medicines told the review last year “the most robust study did suggest an increased risk associated with timing of exposure”.  Also saying the issue is “of public health significance”.

TGA want to replace all the warnings on all Non-Steroidal Anti Inflammatory Drugs 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.”

Although the change wouldn’t take effect until late next year, the TGA website has this 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.