Updated product warnings for Diane-35

The Therapeutic Goods Administration’s (TGA) product and consumer medicine information on the drug now includes significantly more detail about contraindications and the risk of arterial thromboembolism (ATE).
 
‘The risk of arterial thromboembolic complications in CHC [combined hormonal contraceptive] users increases in women with risk factors. DIANE-35 is contraindicated if a woman has one serious or multiple risk factors for ATE that puts her at high risk of arterial thrombosis. If a woman has more than one risk factor, it is possible that the increase in risk is greater than the sum of the individual factors – in this case her total risk should be considered. If the balance of benefits and risks is considered to be negative a CHC should not be prescribed.’
 
The changes come after Federal Labor MP Julian Hill late last year outlined his daughter’s near-fatal experience with a blood clot using Diane-35 as an off-label contraceptive. In an impassioned speech to Federal Parliament in December, Minister Hill called for greater pharmacovigilance in Australia, with patients given more information when prescribed a drug for a purpose other than that for which it is TGA-approved.
 
Minister Hill has welcomed the updated product information.
 
‘This is one step to help prevent other Australian women from developing life-threatening blood clots, and steer people towards safer choices for contraception,’ he said. ‘More needs to be done, however, including consumer awareness, stronger warnings on packaging and access to blood screening tests before higher risk drugs are prescribed.’

Diane-35 Julian-Hill off-label-prescribing TGA