Deaths of two Australians prompt fresh warning for osteoporosis medication Evenity

The deaths of two Australians have sparked new safety warnings on a revolutionary osteoporosis medication that failed to mention related risks.

Exclusive:Safety warnings for a new osteoporosis medication will be severely toughened after two Australians taking the medication died.

The move by the Therapeutic Goods Administration (TGA) should bring the nation in line with Europe and the US, where the product information sheets for the drug Evenity outline the risk of cardiovascular death.

But it is not clear if men will be banned from using the drug, like in other countries, despite them being at a higher risk.

Evelyn Caldow who died age 88 from a stroke her son believes was caused by osteoporosis drug Evenity. Picture: Supplied

The packaging shift follows intense lobbying by the son of one of the drug’s alleged victims and his federal MP Julian Hill, who argued current product information was substandard – and failed to mention the risk of death.

In 2021, Evelyn Caldow had a stroke and died shortly after receiving her second course of the drug Evenity, which increases bone formation and decreases bone loss by inhibiting a protein that is also found in the cardiovascular system.

A few days after her first injection of the drug, the then 88-year-old began to show signs of confusion and her behaviour became increasingly erratic.

After her second course, she collapsed as she left her GP clinic and her blood pressure soared.

Days later she suffered a brain haemorrhage, was hospitalised and then passed away at home.

“I do not want anyone else to suffer unnecessarily,” Mrs Caldow’s son, Wayne, said.

In the US and Canada, the medication’s product information sheet carries a black box warning that it may increase the risk of stroke, heart attack and cardiovascular death.

Osteoporosis medication, EVENITY is for the treatment of osteoporosis in postmenopausal women at high risk for fracture. Picture: Supplied

In the EU and UK, there are similar prominent warnings and it is not to be used in people who have previously had a stroke or heart attack.

In Australia, the drug’s current patient information sheet does not mention death as a possible side effect and the warning about stroke and heart attacks is on page three of the product information document.

Since Evenity was subsidised in 2021, there have been 29 adverse reactions reported in Australia including two deaths, a cerebral haemorrhage, epilepsy and multiple fractures.

The reporting of adverse reactions is not mandatory and such reports do not necessarily mean that a causal link with the medicine is established.

In 2020, Japanese bone expert Hiroshi Kawaguchi reported 68 severe cardiovascular events, including 16 deaths, in its first six months of the medicine’s use in Japan.

Clinical trials of the drug reported between 50 and 53 serious cardiovascular events and 17 deaths.

Previously the TGA had dismissed the need for change but, after being contacted by News Corp, a spokesman for the medicines watchdog said it had received an application from the pharmaceutical company to update the safety warning.

Carole David was diagnosed with osteopenia (low bone density) just after her 50th birthday. Picture: Supplied

“The proposed changes will strengthen the information about serious cardiovascular risk in alignment with other international regulators,” the spokesman said.

Evenity’s manufacturer Amgen said it was “deeply saddened” to hear of Mr Caldow’s loss.

“We can confirm all known side effects are clearly detailed in our Product Information and Consumer Medicine Information summary,” Amgen said in a statement.

Healthy Bones Australia medical director Dr Peter Wong said the medication was “a game changer” that could reduce the risk of osteoporotic bone fractures by up to 50 per cent.

He said specialists were aware of the cardiovascular risks.

“If someone’s had a heart attack six months ago, got unstable angina, is hypertensive, overweight, diabetic or had a stroke recently, this is not the drug for you,” he said.

Retiree Carole David, from the NSW Central Coast, was a healthy and active gym goer when she discovered at the age of 50 she had the “bones of a 97-year-old”.

She was put on Evenity and experienced a 25 per cent improvement in bone density in her spine.

“The drug has ‘given me back my life, my mobility and I’m on a rigid exercise program,” she said.