Critical drug shortage risking pregnant women’s lives, experts warn

A critical shortage of blood pressure medications considered safe for use in pregnancy is putting Australian mothers and babies at risk.

Obstetric experts warned on Monday in The Medical Journal of Australia that supplies of several crucial blood pressure and other drugs considered safe for use in pregnancy are running short, which could leave women at risk of serious complications including brain bleeds.

Doctors are warning that older blood pressure medicines, critical for use in pregnancy in Australia, are in short supply.

Associate Professor Stefan Kane, director of maternity services at the Royal Women’s Hospital in Melbourne, said the fact women of childbearing age and pregnant women are not included in clinical trials means no new blood pressure drugs have become available for use in pregnancy for 30 years.

Existing, older-style drugs that have been used safely in pregnancy are so scarce that some women prescribed the medications, but unable to find them, are experiencing risky blood pressure.

“In Victoria and NSW, and elsewhere, women are finding it very difficult to get medications in the community, and then not taking them and coming back into hospital with much higher blood pressure than can be ideal,” Kane said.

“The effects of uncontrolled, severe gestational blood pressure [include] morbidity, and potentially, mortality. There is significant risk.”

Kane said the shortages had produced “episodes where it has been very serious, and we’ve been very worried about how we will look after women”.

“It has the potential to evolve into a crisis,” he said.

The shortages have been caused in part by the drugs being less attractive to pharmaceutical importers because they are old, inexpensive and off-patent, the journal article says.

“The lack of incentive for pharmaceutical companies to register and maintain the supply of older, off-patent drugs used in pregnancy is putting lives at risk,” Kane said. “We are in a perilous situation where pregnant women are vulnerable to the whims of market forces.”

Co-author Professor Amanda Henry, head of women’s health in Australia for the George Institute for Global Health, said the fact women are significantly underrepresented in pharmacological trials due to historical factors was leading to “under-treatment of conditions both related and unrelated to pregnancy” and to potential harms.

Associate Professor Stefan Kane has seen pregnant women who have been unable to find prescribed medications return to hospital with high blood pressure.Credit: Chris Hopkins

“There are over 300,000 pregnancies a year in Australia, so there are tens of thousands of affected women and babies every year,” Henry said.

If uncontrolled, acute high blood pressure could cause pregnant women to suffer strokes or brain haemorrhages, she said, and some women needed three or four of the few available medications to manage their blood pressure.

Blood pressure-related conditions such as pre-eclampsia can happen in any pregnancy, although the dangerous condition is more common in first pregnancies.

Drugs affected by the shortages include prazosin (sold under the brand name Minipress), clonidine (Catapres) and nifedipine, which is sold under several brand names.

The Royal Australian and New Zealand College of Obstetricians and Gynaecologists has called for urgent intervention to prevent worsening shortfalls.

Obstetrician Dr Anna Clare, of RANZCOG, said no arm of government had responsibility for ensuring the supply of such drugs, or others including menopausal hormone therapy.

Clare agreed with Stefan Kane that “protecting” women of childbearing age from any potential harm by keeping them off international drug trials had shifted into causing harm by leaving them out. “This leads to a lot of problems with other medications in pregnancy,” she said.

The college is backing calls from the authors of the Medical Journal paper for the federal government to create a publicly funded entity dedicated to registering, importing and manufacturing critical medications, to ensure the continuous supply of treatments for conditions including pre-eclampsia, postpartum haemorrhage and nausea.

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