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Updated product warnings for Diane-35


Paul Hayes


17/01/2018 2:08:05 PM

Anti-acne medication Diane-35 has received a number of amended warnings detailing an increased risk of blood clots after concerns were raised about its use as an off-label contraceptive.

Federal MP Julian Hill (left) called for greater pharmacovigilance following his daughter Elenor’s near fatal experience with off-label prescribing.
Federal MP Julian Hill (left) called for greater pharmacovigilance following his daughter Elenor’s near fatal experience with off-label prescribing.

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



Eileen Gourley   19/01/2018 12:01:07 PM

As previously highlighted when Mr Hill brought this “issue” to light- the risk is from the medication not from lack of pharmacovigilance or controls. It is usual for a GP to explain risks and benefits of any new medication. If his daughter wasn’t taking Diane for contraception then presumably she would have been taking another equally “risky” pill (still less than the risk of clot in pregnant mind you). Off label or not medication have risks and it’s naive of any patient to presume they don’t, and poor practice for any GP to not discuss them as we aim to reduce risk as much as possible. I’d much prefer our politicians were looking at the health system problems rather than attempting to apply clinical judgement to one minor area of health care.


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