A federal MP has called for a contraceptive pill known as Diane-35 to be banned in Australia, claiming it caused a blood clot that nearly killed his 20-year-old daughter. He says that since he shared his daughter’s story, he’s been “deluged with horror stories” from other women, who were similarly unaware of the medication’s potentially life-threatening risks.
Speaking in Parliament last night, MP for Bruce Julian Hill told his daughter Elanor’s story, which he now believes illuminates a more widespread problem in Australia. In January this year, Hill and his daughter were on holiday in Sri Lanka when Elanor began to experience severe pain in her leg. As she worked as a medical receptionist, she recognised the symptoms of deep vein thrombosis, and urged her father to drive her to a hospital.
Elanor was right — it turned out that she had developed a 64-centimetre, life-threatening blood clot in her leg. She spent the next week in hospital, and the next year on blood thinners, having blood tests and scans every few days, and wearing a full leg compression stocking.
While the clot has now cleared, many of the consequences may be lifelong: she still experiences swelling, vein damage and intermittent pain. She cannot take oestrogen-based medication again, and faces higher insurance premiums.
It was only after the life-threatening scare that Elanor discovered that Diane-35, the contraceptive she had been prescribed, raised her risk of blood clots — more so than other, newer contraceptive medication. She said her doctor never warned her of the risks involved, nor that the medication should not be taken on long-haul flights. She also discovered she has a pretty common genetic variation (affecting 1 in 20 women) which increased her risk of blood clots further, but was never tested for this before the pill was prescribed.
“I have no hesitation in saying there are women in Australia who needlessly die or are harmed due to this drug,” Hill said. A spokesperson for Hill told Junkee that the number of women approaching the MP’s office to share similar stories was in the hundreds.
Why Is This Drug Still Being Prescribed?
Part of the problem, Hill said, is that warnings about the dangers of the drug aren’t being adequately heeded. “This drug has never been approved for use in the USA and was actually banned in Europe in 2013 after too many women died from blood clots, and only reintroduced with tough restrictions,” he told Parliament.
“Yet it’s routinely prescribed to Australian women without proper warnings, education or consideration of safer, modern alternatives.”
The Australian Therapeutic Goods Administration (TGA), which is responsible for ensuring medication used in Australia is safe, only registers Diane-35 (also marketed as Brenda-35, Carolyn-35, Chelsea-35, Estelle-35, Ginette-35, Juliet-35, Katie-35, Laila-35 and Dermapil) as medication for two conditions: hirsutism (or abnormal hair growth) and acne. While it can also be an effective contraceptive for people with these conditions, it is not recommended as a contraceptive for people without these conditions.
Despite this, Hill said “unknown thousands of Australian women are prescribed it ‘off-list’ or – ‘off-label’ – because a side effect of this drug is it’s an effective contraceptive even though it’s not registered in Australia for this purpose.”
“The reality is that despite this drug not being approved as a contraceptive in Australia, Doctors and pharmacists think of it as one. It’s listed under contraceptives in pharmacy manuals and stored with them.”
Hill told the Parliament that after speaking to the TGA, the Pharmacy Guild, the Royal College of GPs, the Pharmaceutical Society of Australia, and the National Prescribing Service, he was convinced that off-list prescription of drugs like Diane-35 are a huge problem.
“Everyone I’ve spoken to has admitted this drug is a problem,” Hill said. “A refreshingly direct statement came from my meeting with Dr. Bastian Seidel, President of the Royal Australian College of General Practitioners who told me he doesn’t think Diane-35 should be available any more in Australia. He wisely observed that the real issue is that it is an old drug: but we don’t de-list legacy drugs, even when there are newer and safer alternatives.”
That’s exactly what Hill’s trying to do now. He told Parliament he’s seeking to have Diane-35 either banned or seriously restricted in Australia, and has started a petition to that effect.
“It is clear to me that we need to improve Australia’s overall pharmacovigilance regime – or in plain English, our drug safety systems that minimise harm,” he said.
Hill’s calls for the TGA to investigate Diane-35 and review its status in Australia were backed by the Royal Australian College of General Practitioners, the peak body for GPs in Australia. RACGP President Dr. Bastian Seidel told Junkee that while doctors are well aware of the risks involved and are well placed to communicate them to patients, “what we are looking for is the concept of radical transparency — we need to be sure patients understand the risks of any drug”.
While the TGA did not confirm whether it would be looking into Diane-35, it told Junkee that “health professionals are encouraged to use caution when considering ‘off-label’ prescribing and to clearly communicate the potential risks and benefits with patients and/or their carers before deciding on a treatment.”
“Off-label prescribing may be clinically appropriate in some circumstances, but [the TGA] recommends that such use only be considered when other options are unavailable, exhausted, not tolerated or unsuitable.”
Bayer, the manufacturer of Diane-35, told Junkee that “patient safety is of the utmost importance to Bayer”, and that the company “continuously reviews the safety profile of its products worldwide and collaborates with health and regulatory authorities, sharing 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”, noting that the risks are outlined in the product information.