A coroner has delivered a ruling of death by medical misadventure in the case of a pregnant woman who died at the Mater Hospital in 2010.
Bimbo Onanuga, who was seven months' pregnant, died at the Dublin hospital after being transferred there from the Rotunda Hospital on 4 March 2010.
Earlier, Director of Scientific Affairs at the Irish Medicines Board Dr J M Morris gave evidence at the inquest at Dublin Coroner's Court.
Dr Morris told the court that misoprostal, a drug given to Ms Onanuga in the Rotunda, was not approved for use to induce labour.
Such use is called off-label and is done on the responsibility of the doctor who gives it.
It is approved in Ireland for management of ulcers.
This does not mean it is illegal or improper to use it for inducing labour, but the drug company has not applied for IMB approval for that use.
Off-label use is common across Europe.
Dr Morris was asked by Coroner Brian Farrell if it would not be useful for hospitals and doctors engaging in off-label use to inform the IMB.
He said to have the information might be useful, but he was not sure what the IMB would do with it and there were a lot of drugs used off-label.
The court also heard that misoprostal is not approved for the induction of labour in the UK.
He confirmed that the safety data the IMB has for misoprostal is for oral administration, not for internal administration as is sometimes used for pregnant women.
Master of the Rotunda Dr Sam Coulter-Smith also gave evidence at the inquest.
He rebutted evidence from Ms Onanuga's partner, Abiola Adesina.
Mr Adesina yesterday told the court that at a meeting shortly after Ms Onanuga's death Dr Coulter-Smith had said the death was due to a series of mistakes.
He said he would not have said this as he did not have sufficient information to say it.
Dr Coulter-Smith said there are risks when using misoprostal if there has been previous scarring or perforation of the uterus, but there was nothing in Ms Onanuga's medical notes to indicate such a risk.
A post-mortem examination later revealed that there was scarring due to a previous termination of pregnancy. But that knowledge came only in hindsight.
Dr Coulter-Smith was asked by the coroner if the use of the drug used, misoprostal, was a factor in the uterine rupture that led to Ms Onanuga's death.
He answered that the induced contractions led to the rupture and he did not think the drug used to induce those contractions was a factor.