Extreme morning sickness drug comes at a price

By Dr. Ananya Mandal, MDJan 31 2011

Women, who suffer from an extreme form of morning sickness called hyperemesis gravidarum (HG), are shelling out $7,000 for a drug not yet approved for use by expectant mums because they are desperate to control their illness. HG leads to severe nausea, dehydration and fatigue and may require hospitalization. It affects up to 3 per cent of pregnant women - about 9,000 per year in Australia. It may lead to termination of the pregnancy.

At present obstetricians are prescribing the anti-nausea drug Zofran - used to stop nausea in chemotherapy patients to women with HG. The manufacturers have not sought approval from the Therapeutic Goods Administration to have it used or subsidised under the Pharmaceutical Benefits Scheme for pregnancy sickness and thus it costs $8 per pill.

According to Sydney obstetrician Jim Ferry Zofran was often the only drug that provided any relief. “We are not talking about women who have a little bit of morning sickness…These women are seriously ill, they are vomiting almost constantly, they are bedridden and unable to function,” he said. He added that this drug should not be available at the discounted PBS price to all pregnant women, but that severe sufferers should get assistance. “I have had women terminate wanted pregnancies because they just cannot cope with the effects of hyperemesis,” he said.

Obstetricians describe HG as an under-diagnosed and under-managed condition which is often wrongly overlooked as morning sickness. It is a genetic condition and if a woman suffers it in her first pregnancy there is a 95 per cent chance she will suffer again in subsequent pregnancies.

At present Zofran, which is manufactured by GlaxoSmithKline, is listed on the PBS for use by cancer patients to treat vomiting associated with chemotherapy. According to a spokeswoman from the Federal Department of Health, the drug had not been considered for listing on the PBS for pregnant women as the Therapeutic Goods Administration had not listed treatment of the condition as one of the drug’s intended uses. A spokeswoman from GlaxoSmithKline in reply said treatment of any pregnancy-related nausea was not one of the intended uses.