NSAID Changes

Medsafe has launched a public consultation on a proposed change to the warning statements on labels of non-steroidal anti-inflammatory drugs (NSAIDs) available without a prescription.  The move follows a recent meeting of the Medicines Adverse Reactions Committee which discussed the risk of spontaneous abortion in pregnant women taking the medications.

The Committee recommended that Medsafe update the Label Statements Database to amend the warning statements regarding use in pregnancy for oral medicines containing NSAIDs available without a prescription. In particular, the proposed revised statements add a new warning not to use NSAIDs if trying to become pregnant or during the first six months of pregnancy, except on the advice of a doctor.

The expanded warning would also apply to all oral dose forms (solid and liquid) of ibuprofen, diclofenac, naproxen, mefenamic acid, flurbiprofen and benzydamine. The current warning statement only applies to diclofenac and ibuprofen sold as OTC medicines for oral use.

Feedback is sought by close of business on 15 Sep 2017. Medsafe noted that if the proposal was accepted the move would result in harmonised package labelling for New Zealand and Australia, which may be desirable for both consumers and industry to reduce confusion.

Source: pharmacydaily.com.au, Monday 24 July 2017