An osteoporosis drug’s warning label may be tightened after a Dandenong man’s sustained campaign to the Federal Government.
Dr Wayne Caldow’s mother Evelyn, 88, collapsed soon after her second injection of Evenity at a Dandenong clinic in 2021.
She was “active and engaged” and a “fighter” despite a previous stroke in 2009.
Days after taking the second Evenity dose, she suffered a brain haemorrhage and subsequently died.
Since then, Dr Caldow has campaigned for two years to strengthen the “seriously deficient” Evenity warning label – in line with warnings in the US, Canada, UK and EU.
He claims the Therapeutic Goods Administration’s approval is an “aberration” compared to overseas.
“In its approval of Evenity, the TGA deleted all the clinical trial data about cardiovascular death. It concealed the worst possible effect of this drug.
“It has downplayed the cardiovascular risks throughout its documentation.
“I am not arguing against the efficacy of Evenity but it needs to carry clear warnings in line with overseas regulators so that more people do not unnecessarily suffer heart attacks and strokes or die.”
Dr Caldow has been backed by Bruce MP Julian Hill in his thoroughly-researched investigation into the drug’s approval, which points to international clinical trials reporting at least 50 serious cardiovascular events including 17 deaths.
In the US and Canada, a black box warning states Evenity may increase the risk of stroke, heart attack and cardiovascular death.
Health bodies in the EU and UK took steps to limit Evenity to only sufferers of severe osteoporosis. As in Canada, they advise it cannot be used in people who previously had a stroke or heart attack.
However in Australia, the warnings are “buried in the fine print”, Caldow says.
On the Australian product information (PI) document, there is no black box warning and no mention of death as a possible side effect.
Stroke or a heart attack aren’t mentioned as potential side-effects until the bottom of page three.
Dr Caldow said this was “highly disingenuous” because the TGA and Amgen are fully aware of how Evenity is regulated overseas and what warnings are in place, and most importantly, why. The warnings provided by Health Canada and the European Medicines Agency are easy examples to follow.
He said the problem for Australian patients was that the TGA had chosen to depart from the consistent approach taken by regulators in the USA, Canada, the EU and the UK – without any explanation.
Last month, the Therapeutic Goods Administration stated Evenity’s sponsor Amgen had applied to “update and strengthen” the drug’s PI document “in relation to serious cardiovascular risk”.
“The label has not yet been updated as the TGA is currently in negotiations with the sponsor to ensure the wording in the PI on this issue aligns with other international regulators’ labels,” a TGA spokesperson said.
Amgen stated it was “unable to provide any further information” on its proposal – due to the matter being reviewed by the TGA.
There have been 26 reported adverse reactions from Evenity patients in Australia, including two deaths, on the TGA’s notification database.
Most of the reported adverse reactions happened in women – at least 54 per cent were 65 and older.
However, the link between Evenity and the events has not necessarily been confirmed by the TGA.
The events may be related to the medication, an underlying illness or other factors, a TGA spokesperson noted.
“It may be a coincidence that the adverse event occurred when the medicine was administered or taken.”
Dr Caldow said that “in other countries, the cardiovascular risk posed by Evenity is an acknowledged fact”.
“This has led to clear, strong warnings and strict regulation of its use. These statements from the TGA are further indication that it is unwilling to admit that it got it wrong.”
In a letter in late 2022, Health Minister Mark Butler stated he’d been advised that the Australian PI gave an “accurate” and “balanced” description of relevant trial results.
“The TGA concluded … a causal relationship between romosozumab (Evenity) and cardiovascular serious adverse events had not been established but could not be excluded.”
In response, Dr Caldow notes that this important qualification is not included in the PI document.
Recently, Mr Hill wrote to Mr Butler that “I am not convinced by the TGA’s previous advice to you” and was “very concerned about what appears to be Australia’s relatively lax approach”.
Hill stated Caldow’s report “credibly documented in great detail the significant divergence between the approach to regulating this risky drug in Australia and the much more serious warnings … most notably in the EU, UK, Canada and USA”.
Health Minister Butler’s office was contacted for comment.
