Effects of oral contraceptives monitored closely

19 June 2000

Effects of oral contraceptives monitored closely

DOCTORS have been asked to monitor and report any cases of blood clots in women taking oral contraceptives for the last four years, the Ministry of Health says.

Commenting on calls from Women's Health Action for better monitoring of the risks associated with the pill Ministry spokesman Dr Stewart Jessamine said there was a standing request to all prescribers to report any adverse reactions to medicines.

In addition, the Ministry's Medsafe division in February 1996 asked all prescribers to report all blood clots in women taking oral contraceptives. "The number of reports received about side effects from oral contraceptives has increased substantially since," Dr Jessamine said.

"These reports are made to the Centre for Adverse Reactions Monitoring (CARM) and cannot identify all cases as they are based on voluntary reporting by doctors.

"This is taken into account when we are providing advice to prescribers or consumers. We know that the number of reports of the frequency of particular side effects, such as blood clots, will be lower than actually occurs. Even though New Zealand has amongst the highest reporting rates in the world, and its rate of reporting is higher than in some countries where reporting is compulsory, the data was incomplete.

"The research conducted by the Otago University team led by Professor David Skegg provided information on the risk of death which could not be obtained from voluntary reporting of side effects."

Professor Skegg's research - which showed 20 women taking the pill had died of blood clots since 1990 - confirmed that not all deaths had been reported to the CARM, Dr Jessamine said.

"The study also confirmed that our advice to doctors, first issued in 1996 and based on the supposition that the risks for New Zealand women would be in line with those found in other countries was appropriate.

"Monitoring side effects from oral contraceptives more closely will be discussed at the next meeting of the Medicines Adverse Reactions Committee. It may be necessary to develop a new method to do so as an existing programme, the Intensive Medicines Monitoring Programme, is not designed to collect data on such large groups as the 200,000 women using oral contraceptives."

Funding for the Centre for Adverse Reactions Monitoring, where information is collated and analysed, has been more than doubled this year, he said.

ends For more information contact: Frances Ross Chief media advisor Ministry of Health Tel: 496 2202/025 512 833

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