Robyn Hughes believes a hormone-based pregnancy testing drug she took in 1977 caused health problems in her son. Photo / File
More than 3000 New Zealand women took a hormone-based pregnancy test now suspected to cause malformations in some babies.
Information held by the Ministry of Health shows monthly sales of the drug, Amenorone Forte, was 252 units in New Zealand in 1974.
A documentary thrust the issue into the limelight again in March last year with allegations that UK regulators knew there was a potential five-to-one risk a similar drug called Primodos, made by Schering, could cause deformities, but did not warn the public.
Bayer, the company which now owns Schering, said it could not provide figures on sales of Primodos in New Zealand. British studies found Primodos and similar drugs produced by Roussel (Norone, Amenorone and Amenorone Forte) accounted for 90 per cent of the sales of hormone pregnancy testing drugs in the UK.
The Ministry of Health last year confirmed Primodos and Amenorone Forte were sold and used in New Zealand from 1966 to June 1975 when what was then the Department of Health ordered they be pulled from shelves after concerns began to be raised overseas about the effect on babies.
Information from Medsafe released to the Herald showed 11 women had now reported adverse reactions they believed stemmed from taking a hormone-based pregnancy test like Primodos or Amenorone Forte.
In 1973, one 42-year-old woman reported paralysis of one side of her body after taking Primodos. The other 10 cases were only brought to Medsafe's attention after media attention in March last year and most could not recall exactly what drug they had taken.
The reactions reported in the babies of women who took the drug included abnormal bone development, joint dislocations, stillbirth, head and brain deformities, breathing problems, spina bifida, kidney and bladder problems and muscle absence.
According to the Centre for Adverse Reaction Monitoring there was one report of fetal malformation in 1976 which may have been associated with Amenorone Forte.
A 32-year-old woman contacted the centre after taking a drug with the same ingredients and reported that her baby had a cleft lip and palate, ear problems, spinal malformation, a deformed arm, a hole in the heart and anomalies in the urinary and genital organs. The centre reported that while the strength of the drugs did not match up with the strength of the ingredients in Amenorone Forte, it was likely a transcription error.
Tauranga woman Robyn Hughes was one of those women who got in touch with Medsafe.
She shared her story last year and called for the Government to form a working group to investigate the use of the drug.
She was prescribed a hormone-based pregnancy test when she fell pregnant in 1977 and now believes that was what caused her son to be born premature and with tracheostenosis - a narrowing of the trachea.
She was not surprised by the amount of Amenorone Forte sold and said she expected the amount of Primodos would have been greater.
She also believed there were many more people affected by the drugs in New Zealand than the 10 others who came forward.
"Many women will have miscarried, had stillborn babies, babies who died in infancy and childhood and who never made the connection with the drugs they had been given. Many of those women will now be 60 plus or no longer alive. Their families and surviving children may never have known about a brother or sister who died in childhood or know their mother took a drug which affected them. Some people who live with health and disability issues may well have been survivors of hormone pregnancy tests."
At the same time Hughes was calling for a government inquiry last year, Labour's Health spokesman David Clark called for the Government to establish a register and set up a contact number for women concerned they might have been affected by one of the drugs.
Asked what he intended to do now he is Minister of Health, Clark said he had not yet been briefed on the issue by health officials so he could not comment.
An expert working group was set up in the UK to look into the cases of hundreds of families who believed a similar hormone-based pregnancy testing drug, Primodos, had cause deformities in their children.
The group's report was released in October and found no link between the drug and the deformities.
Those who believe they were affected by the drug have criticised the working group's handling of the issue and labelled the report a "whitewash".
Hormone Pregnancy Tests
• Primodos, a pregnancy-test pill, was introduced in 1958 in Britain and was on the market for 20 years.
• The first mention of Primodos in New Zealand was in New Ethicals in 1966.
• Primodos was distributed by Schering in New Zealand from 1966 and banned here in 1975, taking effect from June 9.
• Amenorone Forte first became available in New Zealand in 1968 and was withdrawn at the same time as Primodos, in June 1975.
• The drugs contained strong hormones which were later used in the morning-after pill and in oral contraceptives.