THE Therapeutic Goods Administration (TGA) is reviewing the wording of advisory statements to create more consistency around the effects of NSAIDs in connection with miscarriage or spontaneous abortion.
The move follows a review of the Product Information (PI) documents and package warnings for all NSAIDs, including comparisons of Australian and international PIs, published literature and therapeutic guidelines and an analysis of case reports from the TGA Adverse Drug Reactions System database.
The TGA seeks comments from interested parties on the wording of an additional advisory statement for the NSAID range of medicines, namely diclofenac, flurbiprofen, ibuprofen, ketoprofen, mefenamic acid and naproxen for oral use, proposing the inclusion of the statement 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 in the last 3 months of pregnancy.
The Australian Self-Medication Industry responded to the NSAIDs review, saying it was not prompted by new evidence, but rather aims to achieve consistency among label warnings for NSAIDs.
Consequently the label warnings will apply to period pain-specific NSAID products, which are currently not required to carry a warning about using them if likely to become pregnant.
In addition, the TGA is similarly consulting on proposed new Required Advisory Statements for Medicine Labels for combinations of paracetamol and ibuprofen.
Both consultations have a closing date of 22 Nov, with submissions able to be uploaded online or submitted in hardcopy by post.
For more info see tga.gov.au.
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