Woman, 28, forced to have abortion after she was wrongly prescribed acne drugs which left her unborn child seriously disabled

A mother-to-be was forced to have an abortion after being prescribed acne drugs that left her unborn child severely disabled.
Sarah Sharma, 28, was told at her 20-week scan that her baby had such serious heart and nervous system abnormalities that she would not survive after birth.
The diagnosis came after she fell unwell within weeks of taking acne medication Roccutane – also known as Isotretinoin. 

Sarah Sharma (pictured with husband, Varun) had to have an abortion after acne drugs caused her unborn baby to develop with severe heart and nervous system abnormalities

Mrs Sharma (pictured with daughter Asha, four-months-old) was prescribed Roccutane by doctors at Peterborough City Hospital. She and Mr Sharma won undisclosed damages after the abortion last January

The drug is so strong that women are made to take a pregnancy test before being prescribed it. They must also be using one, if not two forms, of contraception.
Unbeknown to her, she was pregnant when the medication was prescribed and proper tests were not carried out to ensure it was safe for her to take it.

ROACCUTANE: A DRUG SO POWERFUL IT CAUSES BIRTH DEFECTS

Roaccutane is such a strong drug that women are made to take a pregnancy test before being prescribed it.

They must also be using one, if not two forms, of contraception.

NHS guidelines state: 'If you are a woman and you are taking Isotretinoin (Roaccutane), you must not become pregnant during treatment and for at least one month after stopping treatment.
‘You must use one form, or preferably two forms, of effective contraception one month before you begin treatment with Isotretinoin.
'You must continue to use this contraception while you are taking Isotretinoin and for at least a month after you have stopped taking Isotretinoin.
‘Treatment with Isotretinoin can only be started in a woman once the prescriber is certain that the woman is not pregnant.
‘Women will need to have a pregnancy test before, during and five weeks after stopping treatment with Isotretinoin.’

Although she was given one pregnancy test by hospital staff, this came back negative.
Procedures at Peterborough City Hospital, where Mrs Sharma was treated, have now changed so that women will only be given the drug following two negative pregnancy test results taken a month apart.
The hospital has since apologised for the error and Mrs Sharma has now spoken out to highlight the dangers of the drug.
Mrs Sharma, from Huntingdon in Cambridgeshire, who named the unborn girl Indiya, said: ‘It has been an incredibly difficult year for us.

‘Losing Indiya was devastating but to find out after that her condition, and subsequent death, could have been prevented is almost unbearable.
‘I am pleased that the trust has now admitted that they made mistakes, but what we really want are assurances that no one else will ever have to go through what we did.
‘People place their trust in medical professionals all the time; it would never have occurred to me that they were not doing absolutely everything in their power to ensure nothing went wrong.’
Following the diagnosis, later confirmed during an autopsy as fetal isotretinoin syndrome, medical staff advised Mrs Sharma to terminate the pregnancy.
She was left with no choice but to deliver baby Indiya on January 23 last year, 21 weeks into her pregnancy.

Before Mrs Sharma was given the drug she should have been asked to take more than one pregnancy test to ensure that she was not pregnant because it is known to be harmful to unborn babies

Mrs Sharma was told at her 20-week scan that her unborn baby was severely disabled. She had to have an abortion and the baby, Indiya, was delivered when she was 21 weeks pregnant

Peterborough and Stamford Hospitals NHS Foundation Trust later admitted that had staff followed basic procedures when prescribing the drug, they would have known in advance that she was in the early stages of pregnancy and that Indiya’s death could have been prevented.
NHS guidelines state: ‘If you are a woman and you are taking Isotretinoin (Roaccutane), you must not become pregnant during treatment and for at least one month after stopping treatment with Isotretinoin.

WHAT DAMAGE CAN ROACCUTANE DO TO BABIES?

Foetal retinoid syndrome is caused by retinoid drugs, including Roaccutane.
Birth defects associated with the drugs include hydrocephalus (water on the brain), microcephaly (a neurological condition), intellectual disabilities, ear and eye abnormalities, cleft palate and heart defects.
Roaccutance can cause these birth defects in the early weeks of pregnancy, before a woman even knows that she is pregnant.

‘You must use one form, or preferably two forms, of effective contraception one month before you begin treatment with Isotretinoin. You must continue to use this contraception while you are taking Isotretinoin and for at least a month after you have stopped taking Isotretinoin.
‘Treatment with Isotretinoin can only be started in a woman once the prescriber is certain that the woman is not pregnant.
‘Women will need to have a pregnancy test before, during and five weeks after stopping treatment with Isotretinoin.’
The couple, who have since had a baby girl whom they named Asha, have received an undisclosed settlement from the trust and plan to donate funds to Hinchingbrooke Hospital in Cambridgeshire where Mrs Sharma was referred following the errors at Peterborough City Hospital.
John Randall, medical director at the trust, apologised for the trauma the family experienced.

The hospital has now changed its procedure so the drug is not prescribed to any woman until she has had two pregnancy tests carried out a month apart

‘After a consultation with the patient, clinical staff took a balanced judgment to start Mrs Sharma’s treatment.
'This was after results came back negative from a pregnancy test and conversations were held with Mrs Sharma about contraception,’ he said.
‘As a result of lessons learned from this incident, our procedures have changed so that any drug treatment will only commence following two negative pregnancy test results taken a month apart, when women have been using appropriate contraception in line with guidance.
‘I’d like to reassure patients that we have taken every precaution to ensure this doesn’t happen again.’
Medical law and patients’ rights expert Anna Mannin, from Irwin Mitchell, said the trust failed to abide by British National Formulary and manufacturer guidelines and failed to ensure that Mrs Sharma was taking effective oral contraceptive pill for at least one month before the prescription.
‘This is a truly devastating case made all the more horrific given that Indiya’s condition and tragic death could have been avoided had the trust followed very basic, routine procedures when prescribing the acne medication,’ she said.
‘Despite the fact that this particular acne drug is associated with such harmful effects in unborn babies, medical staff failed to properly advise Sarah and heed the necessary precautions in place to protect her and her daughter.
‘Appropriate guidelines are already in place that should prevent tragedies such as this occurring but clearly here the system failed.’

Peterborough City Hospital has apologised to Mr and Mrs Sharma and has reassured patients that this will not happen again

Mrs Sharma’s husband, Varun, said: ‘As a husband and a father, it was heart breaking seeing my wife go through the pain of labour, knowing we would never get to take that baby home as parents should at the end of it. We were left with nothing but broken hearts and empty arms.
‘I lost all faith in the NHS the day Indiya was born sleeping. They were meant to improve my wife’s health but instead they broke her.
‘However, we would like to express our sincere thanks to Hinchingbrooke Hospital for all their help and support during our loss, subsequent pregnancy and birth of our second daughter, Asha.’

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