“Almost a yr in the past a 64cm blood clot nearly killed my wholesome 20-year-old daughter, Elanor, after she was prescribed an previous and harmful drug, Diane-35,” Hill mentioned in a speech to parliament on Tuesday evening.
Elanor complained of calf ache whereas the pair have been on vacation in Sri Lanka in January and self-diagnosed as having deep vein thrombosis (DVT) earlier than medical doctors at a hospital confirmed the clot in her leg.
“Since first speaking publicly of our expertise, I’ve been deluged with horror tales of life-threatening or deadly blood clots by households from throughout Australia.
“I’ve no hesitation in saying there are girls in Australia who needlessly die or are harmed as a consequence of this drug.”
Diane-35 (also referred to as Diane 35 and Diane 35 ED) can be obtainable beneath the commerce names Brenda-35, Juliet-35, Estelle-35 and Laila-35. It is registered in Australia by the Therapeutic Items Administration (TGA) for 2 points: idiopathic hirsutism (extra hair progress in girls) and zits.
It’s not registered as a contraceptive however is however it’s prescribed as an “off-label” (not on the Pharmaceutical Advantages Scheme) contraceptive.
Hill informed the parliament that his daughter was by no means suggested the medication was an off-label prescription, warned that the danger of blood clots was greater than different contraceptives, or educated about warning indicators.
“Within the case of Julian’s daughter’s DVT, if this blood clot had travelled up into the lung space it will trigger a pulmonary embolism and it will have been probably deadly,” Seidel informed BuzzFeed Information.
“The unwanted side effects we’re speaking about usually are not a little bit of an itch or a rash, we’re speaking about folks dying.”
In 2013, France’s medical authorities confirmed 125 girls had suffered “undesirable” and probably life-threatening side-effects, and that 4 deaths prior to now 25 years have been linked to the drug.
Seidel echoed Hill’s calls to ban the treatment.
“Diane-35 is usually prescribed to enhance pores and skin situations and as a contraceptive, however there are numerous different choices on the market which can be much better and safer for girls to think about within the 21st century,” he mentioned.
“There have to be a push to take this legacy treatment off the market and to make sure there are higher choices on the market for girls.”
Household Planning NSW medical director Dr Deborah Bateson mentioned all oral contraceptives elevated the danger of blood clots, however the danger was “very small” for most ladies.
“However drugs like Diane-35 have a better danger and ought to be reserved for girls with extreme zits, however even then these signs might be settled with a decrease danger tablet,” Bateson informed BuzzFeed Information.
“There may be anecdotal proof these kinds of drugs are over-utilised in Australia when there are many sorts of drugs available in the market with estrogen in them that are good for zits.”
Bateson warned Australians on Diane-35 to not “cease taking their tablet in a single day” and as an alternative discuss to their physician.
She additionally famous that lengthy haul flights would enhance the danger of clots for girls on oral contraceptives.
Diane-35 is bought completely in Australia by Bayer.
“Affected person security is of the utmost significance to Bayer and we’re at all times saddened to listen to of anybody experiencing an hostile occasion on any treatment.
“Diane-35 has a beneficial benefit-risk profile when used as directed, and this was confirmed by opinions performed by each the European Medicines Authority and the TGA in 2013,” she mentioned.
“Bayer repeatedly opinions the protection profile of its merchandise worldwide and collaborates with well being and regulatory authorities, sharing all related info.”
Additional security info associated to venous thromboembolism was added to the Australian product info after the TGA evaluation.