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 Drug shock - Manufacturer admits likelihood of birth defects 

Drug shock - Manufacturer admits likelihood of birth defects

22/11/2007 3:01:12 AM
Nearly 2000 women at St George Hospital were given a 35-cent drug which can cause birth defects.

Misoprostol was used by the maternity unit over a seven-year period to induce labour in 1998 patients.

Compared with the commonly used vaginal prostaglandin E2 gel (dinoprostone), misoprostol cost only 35cents a dose and did not require refrigeration, researchers at the hospital said.

Misoprostol was used by the hospital to induce labour between July 1998 and October 2005, despite not being licensed for this use in Australia. Its use was approved by the Ethics Subcommittee for Off-Label Drug Usage.

The drug, which is marketed as Cytotec, is registered in Australia as an anti-stomach ulcer medication.

A review of its use at the hospital, published in the Australian and New Zealand Journal of Obstetrics and Gynaecology this year, found that it was an "effective and safe agent to induce labour".

The purpose of the review was to examine the maternal and neonatal outcomes of women who received misoprostol.

But a spokeswoman for the South Eastern Sydney and Illawarra Area Health Service revealed yesterday that there were cases before the area health service's insurer.

"We are advised that given there are currently cases submitted to our insurer, we are not in a position to comment [further]," the spokeswoman said.

Pfizer, which acquired the maker of the drug, warns it "can cause abortion, premature birth or birth defects".

A woman who took part in a misoprostol drug trial at Wagga Wagga Base Hospital and gave birth to a son with cerebral palsy has now sued the hospital.

The misoprostol trial at that hospital involved only 250 women.

St George Hospital ceased using misoprostol to induce labour after the review found that legal concerns "made its future use in normal clinical practice unlikely".

"Although it is used widely in Britain and the US for the induction of labour, legal concerns make its future use in Australia doubtful except in clinical trials," the review stated.

Director for the Centre for Midwifery, Child and Family Health at the University of Technology and co-author of the review, Caroline Homer, said the drug was found to be an effective and safe agent to induce labour.

Professor Homer, a former midwifery consultant in practice development at the hospital, told the Leader it was "sad" misoprostol was no longer used.

She said in NSW in 2004, 24 per cent of all labours were induced. There were risks involved with any drug used for the induction of labour.

"In some ways I still believe it was a very good drug," Professor Homer said.

The Riverina-based law firm that represented the woman in the Wagga case has placed advertisements in the Leader, urging women who received misoprostol at St George to come forward.

Commins Hendriks Solicitors partner John Potter said he had already received responses from some local women.

He said the aim of the advertisements was to obtain further evidence for the Wagga case, however, he said new cases could emerge involving women who gave birth at St George.

Given the hospital's proximity to Sutherland Shire, it is possible some shire women were among those who received the drug.

The misoprostol review at St George Hospital, which did not involve multiple births, found 57 per cent of women did not require stimulation [augmentation] of the uterus during labour to increase the frequency, duration and strength of contractions and that 37 per cent had epidural analgesia [a technique of providing pain relief during labour]. However,

25 per cent required an emergency caesarean section; 16 per cent of babies were admitted to the special care nursery; 7 per cent had a post-partum hemorrhage [a potentially life-threatening complication of delivery]; two women suffered uterine rupture [one of these women had a history and uterine surgery) and two babies died.

The review found that the neonatal deaths were "both because of Group B Streptococcus infection," which in Britain is the most common cause of life-threatening infections in newborn babies. From 2001, misoprostol was not used to induce labour in women who had had a previous caesarean section.

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Comments


The major concern that the use of this drug and the pending court cases highlight is how and when do women receive information within maternity services in Australia. From the Wagga trial it should be clear that trying to obtain consent during labour when a woman is unable to process information is going to result in legal ramifications if the opportunity to make informed consent for a procedure is not obtained.

The over confidence of our present birthing women with medicalised maternity services and the monopoly of service provision by doctors allows and actively encourages normal to be highly interventionalist and reliant on the use of things which interfere rather than assist women to birth.

All women would do better to be told and encouraged to know that they are capable of birthing their babies, we have a genetic blue print that no amount of medicalisation can improve upon.

In the research you detail 57% of the women who used the drug had no legitimate reason for the induction. WHY? Where they informed of the risks?

These are the questions that need to be asked. In the study results it is cited also that 30 women who had previously had surgery were the total cohort of VBAC women, does that then equate to a 1:30 risk representation of uterine rupture?

And does the fact that 2 women suffered uterine rupture out of the 1998 women who have received the drug still sound safe?

What I wonder is the comparative instance of rupture if Nature is left to do the work it is designed to do?

I dare say it is nowhere near this. The greatest lie of this century is likely to be that we have been led to believe medicine can improve upon nature. It cannot, and as long as we continue to promote and praise the use of such interventionist practise and not promote, encourage and facilitate the normal, there will be the grounds for people to sue.

Posted by JANIE NOTTINGHAM on 22/11/2007 8:38:31 PM
Was this drug ever used at other Sydney Hospitals, particularly St George Private and Hurstville Community?

All women should be presented with their full birth history including a list of any drugs used during the birthing process for their own records.

When you are in labour, a first time mum and scared about the whole process and you believe that medical people have the experience, you agree to almost whatever they say.

Questions arise in hindsight and with further knowledge.

Posted by Nessa on 23/11/2007 1:11:09 AM
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Growing concern: Nearly 2000 women at St George Hospital were given misoprostol  a drug which can cause birth defects.
Growing concern: Nearly 2000 women at St George Hospital were given misoprostol a drug which can cause birth defects.

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