A Labor MP is calling for a ban or restriction on an acne treatment which is often prescribed off-label as a contraceptive
Julian Hill, member for Bruce, has started a petition to the TGA asking it to “Save women’s lives: ban the dangerous Diane-35 drug”.
At the time of writing the petition has gathered 527 signatures.
Mr Hill began the campaign after his daughter Elanor was prescribed Diane-35. She suffered a large blood clot while overseas, which he believes was as a result of taking the medication.
He told Sky News’ Samantha Maiden that he had been “scratching into” the medication as well as drug safety regulation in Australia.
Mr Hill’s daughter Elanor had been prescribed Diane-35 “to regulate her irregular periods,” he said, but at the time they did not know that she had a genetic blood disorder which increases her risk of blood clots.
“The same GP who put her on this pill did the travel vaccinations for long-haul flights and she went overseas on long-haul flights, even though the product safety information for this drug says ‘Don’t get on long-haul flights if you’re on it’,” he told Ms Maiden.
When Elanor experienced a blood clot in Sri Lanka, it was “from her hip down to her ankle,” he said.
He said he has met with stakeholder groups including the Pharmacy Guild, PSA, NPS MedicineWise, TGA, RACGP and Royal Pharmaceutical Society about his concerns.
“Everyone understands this drug is a problem,” he told Sky News. “In Australia this drug has never been approved as a contraceptive pill. It’s only listed by the TGA for a couple of things, acne in certain circumstances or hirsutism, excess body hair in the case of androgyny.”
Women aren’t told that prescription for contraception is off-label, he says.
“I’m calling on the TGA to intervene and review the availability of this drug and if it is to remain available I proposed a range of options for tougher restrictions.”
These could include a pack warning, requiring an authority to prescribe or “a mandatory set of blood tests to rule out genetic factors”.
He also suggested a clear pack warning should state that the medicine is not approved in Australia as a contraceptive.
“If consumers know that then pharmacists are able to do some more education for symptoms to look out for at the front counter, currently they have no idea why It’s being prescribed,” he told Ms Maiden.
Bayer sent a statement to the AJP in which it said that “Bayer Australia Ltd is aware of the media coverage on its anti-acne medication, Diane®-35 ED (cyproterone acetate/ethinylestradiol).
“Patient safety is of the utmost importance to Bayer and we are always saddened to hear of anyone experiencing an adverse event on any medication.”
The company says it continuously reviews the safety profile of its products worldwide and collaborates with health and regulatory authorities and shares all relevant information.
“Diane-35 has a favourable benefit-risk profile when used as directed and this was confirmed by reviews conducted by both the European Medicines Authority and the Therapeutic Goods Administration (TGA) in 2013,” Bayer says.
“Further safety information related to Venous Thromboembolism was added to the Australian product information after the TGA review.
“Diane-35 is registered for the treatment of signs of androgenisation in women, such as severe acne (involving inflammation or nodularity or risk of scarring) where prolonged oral antibiotics or local treatment alone have not been successful, or idiopathic hirsutism of mild to moderate degree. Diane-35 ED will also provide effective oral contraception in this patient group.
“Diane-35 has been available in Australia since 1992 and cyproterone acetate/ethinylestradiol products have been used across the world for more than 20 years and by several million women in this time.”
More stakeholders have weighed in, with the sexual health service SHINE SA saying that people who have concerns should speak to their doctor before stopping any oral contraceptive.
“Cyproterone acetate pills, commonly known as Diane-35 appear to be associated with a higher risk of deep venous thrombosis (DVT) than levonorgestrel (LNG) containing pills, although the overall risk is still very low for most people,” said its CEO, Jill Davidson.
“For those who choose combined pills, we recommend as first choice the pills with lowest risk: those containing levonorgestrel or norethisterone as their progesterone.
“However, the other progestogen choices, which all carry a small increased risk of DVT compared to LNG, may be utilised if specific added benefits are required. Health professionals can review over time the experience individuals may have with their contraceptive choice.
“Cyproterone acetate can be used as treatment for signs of androgenisation in people such as severe acne (involving inflammation or nodularity, or risk of scarring) where prolonged oral antibiotics or local treatment alone have not been successful, or idiopathic hirsutism of mild to moderate degree.
“The oral contraceptive pill containing cyproterone acetate can also provide effective oral contraception in this patient group.”