health

Elanor was overseas when her leg began to throb. She never thought the pill would be to blame.

In January, Elanor’s leg began to ache.

It was an ache pronounced enough for her to notice, but an ache quiet enough for her to keep moving. It was a dull, consistent ache that, before long, wasn’t so dull anymore.

“In the beginning, [the pain] was enough for me to not want to walk much. I didn’t feel like I could walk as far as usual, and dad and I, especially when we’re on holidays, really like to walk,” the 20-year-old told Mamamia.

Her holiday was in Europe and her father is Labor MP Julian Hill. In the space of two weeks, that dull ache became a cramping, “throbbing”, “shooting” sensation, and that holiday had moved on to Sri Lanka.

She was “cramping for an hour” one night. On another, it took her ten minutes to walk to the shower from her bedroom.

“The only way I can describe it is that I felt funny, really off. I didn’t feel like I could concentrate and I definitely didn’t feel well. I couldn’t put any pressure on it.

“I said to dad, ‘I think I have a blood clot’. I think at that point he thought I was being a little dramatic,” she says.

But as it happens, she wasn’t being dramatic at all, but it would take them a few more hours to know that for sure.

“We went straight to the local hospital which was 20 minutes away. They told me it was a muscle injury from when I fell over – even though I had never fallen over – bandaged it, and said it would be fine. They wouldn’t do an ultrasound for eight hours.”

After driving four hours to find another hospital – ignoring the “flawed medical advice” of the regional hospital – the results immediately settled their guessing game. Doctors at the second hospital confirmed she had deep vein thrombosis, a 64cm blood clot that had found a home in her leg.

By this point, death was a very real possibility.

Mercifully, Elanor survived the ordeal, but not unscathed. She remains on blood thinners, has regular blood tests, will have to wear a full leg compression stocking for two years and it’s very likely she will never be able to take the contraceptive pill again.

According to Elanor and her federal MP father, this blood clot was entirely avoidable, and a direct result of the 20-year-old being prescribed an acne drug called Diane-35 as a contraceptive pill just four weeks before. The drug in question has never been approved in the United States and was temporarily suspended in France.

Now, the father and daughter are campaigning for tougher regulations on the prescribing of Diane-35 and other similar drugs, with Hill penning an impassioned letter to The Therapeutic Goods Administration (TGA).

The drug, which has the same active ingredients as nine other brands (Dermapil, Estelle-35 ED, Juliet-35 ED, Brenda-35 ED, Chelsea-35 ED, Jene-35 ED, Carolyn-35 ED, Katie-35 ED and Laila-35 ED), is approved in Australia to treat severe acne and the excessive hair condition hirsutism. However, under regulation from the TGA, the drug is not to be prescribed as a first-line contraceptive pill.

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In Elanor’s case, there appears to be either a form of miscommunication between doctors and current regulation, or there’s confusion about how severe those symptoms must be in order for Diane-35 to be prescribed.

Labour MP Julian Hill and his daughter Elanor. Picture: Micromoments Photography.

"I walked into the doctor because I have polycystic ovary syndrome (PCOS) so it [Diane-35] was for irregular periods. The side effects of PCOS can be acne and excessive hair growth, but I didn't have either of those things. If I had those symptoms, I would understand, but I didn't have them, so it doesn't make sense."

A spokesperson for the TGA confirmed current regulations around the prescribing of Diane-35 to Mamamia, saying, "This issue is not new as there has been an established causal link between oral contraceptives and the occurrence of blood clots for some time.

"Information about this link is publicly available from a number of sources...in order to ensure that health professionals and consumers are able to make an informed choice and take steps to mitigate any risks associated with the use of oral contraceptives," the spokesperson said.

In fact, the TGA has been clear, time and time again, that Diane-35 and others like it should not be used solely for contraception, and has been transparent about its potential side effects. At the end of 2016, the TGA published the outcomes of a 2016 review about the risk of blood clot disorders in certain oral contraceptive pills.

The drug's manufacturer Bayer concurred with the TGA, telling Mamamia first and foremost, Diane-35 should be used to treat "signs of androgenisation in women". It can, in the treatment of these things, provide "effective oral contraception".

"Patient safety is of the utmost importance to Bayer and the Company is always saddened to hear of anyone experiencing an adverse event on any medication. Bayer continuously reviews the safety profile of its products worldwide and collaborates with health and regulatory authorities, sharing all relevant information," a spokesperson said.

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Image: Getty,

And so it would appear patients are increasingly reliant on the discretion of the prescribing doctor to either follow or reject current regulation.

According to Dr. Tony Bartone, the Vice President of the Australian Medical Association, the reason doctors would prescribe something like Diane-35 off-label comes down to weighing up the risks and side effects of certain other pills.

He says there may be "a desire a potential to leapfrog other side effects" that would lead to some doctors believing Diane-35 would be the best alternative for any given patients. In short, doctors would be weighing up whether this pill in question would provide less side effects than others. After all, we know all pills come with some varying levels of side effects.

"I am confident with the advice, information and material that is circulating, the prescribing that's happening outside the regulation will become less and less," he told Mamamia.

He added "patients should feel empowered" to ask their doctors for alternatives or about the risks of different kinds of medication.

But for someone like Elanor, who did not know the combination of Diane-35 and an overseas flight could prove near fatal, asking those kinds of questions could be considered futile. After all, you don't know what you don't know.

For that reason, she argues that the onus should never be on the patient. And that's exactly why Julian Hill is taking this to the TGA: to make sure the regulations are clear, and the opportunity for them to be tougher gets its time in the limelight.

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