Pregnancy drug Primodos, which has been linked to birth defects, was once sold in New Zealand, a document suggests.



New evidence has emerged in the United Kingdom which showed women who took the hormone-based pill Primodos, which was also marketed as Duogynon in Germany and Ireland, had a higher chance of having children with severe deformities or other serious health problems.

It was used 30 to 40 years ago, and thousands of British children may have been affected.

Today, Medsafe, which is responsible for the regulation of medicines in New Zealand, said the Ministry of Health was urgently working through its archival files to establish the specifics of use for Primodos in this country, if any.

Advertisement

Medsafe manager Chris James said it had been established that in May 1975 the Department of Health issued a letter advising it was withdrawing systemic hormonal testing preparations for pregnancy testing from the New Zealand market.

"We are continuing to seek further information relating specifically to Primodos," he said. "We're also searching for any files which may be held by the Centre for Adverse Reactions Monitoring in Dunedin."

A document obtained by Newstalk ZB suggests Primodos was used in New Zealand.

The document, an order from German manufacturer Schering, indicates the Ministry of Health asked for the pill to be pulled from New Zealand shelves.

It states Schering was asked to immediately stop selling and exporting the drug to New Zealand in 1975.

It indicates the Ministry of Health forced the drug company to withdraw the drug from the market, to take effect from July 9, 1975.

A Primodos oral packet is held in Te Papa's collection, a sample packet donated by Dame Margaret Sparrow when she donated her collection of teaching materials in 2010 and 2011.

Dame Margaret, one of the first doctors to prescribe the emergency contraceptive pill, said Primodos was sold in New Zealand.

"As far as I know, it was sold for a time then I understand it was withdrawn. But I don't know how frequently it was used.

"When I was working in family planning the commonest way of detecting a pregnancy was to send a sample of urine off to the laboratory. We didn't have do-it-yourself tests in those days."

Damning evidence in the UK suggests Primodos, given to more than a million British women in the 1960s and 70s, may have caused thousands of severe birth defects and life-threatening abnormalities.

Women who took the hormone-based pill Primodos had a higher chance of having children with severe deformities or other serious health problems, the evidence suggests.

Schering continues to deny any wrongdoing.

Medsafe yesterday said: "In terms of the New Zealand context, Medsafe will utilise archival material to ascertain the extent of use in this country, if any."

The spokeswoman said Medsafe had a memorandum of understanding with its British equivalent, the Medicines and Healthcare products Regulatory Agency (MHRA), and would receive any relevant information as soon as it became available.

Labour's health spokesman David Clark said officials needed to establish a registry and provide information for people who think they may have been affected.

"That should happen post-haste. The evidence in the UK points towards thousands of families being affected. I understand the drug was prescribed in New Zealand and there may be dozens or hundreds of women and families affected here."

Women's Health Action strategic adviser George Parker said the organisation did not hold a lot of information about the drug but supported the review that was under way into the safety of Primodos as well as Medsafe's inquiry into the extent of its use in New Zealand.

Parker said she encouraged women who had taken the drug to get in touch with Women's Health Action or Medsafe to register any concerns.

While the extent of the damage done by Primodos was unclear, history was not reassuring, Parker said referring to the effects of thalidomide and the Dalkon Shield.

She advised women to retain a level of cautious scepticism around drugs or devices prescribed during pregnancy and seek help to make an informed decision.

Primodos was introduced in 1958 in Britain and was on the market for 20 years. It contained strong hormones which would later be used in the morning-after pill.

British media reported that hundreds of families have long claimed that Primodos caused birth defects and they have been battling for years for compensation.

Until now, campaigners were unable to establish a causal link between the drug and their babies' health problems.

But they have been given hope by the discovery of archived documents in Germany which drew a connection between the two.

That has prompted the campaigners to allege a cover-up and compare it to the thalidomide scandal, in which thousands of mothers gave birth to children without limbs or with other defects after being prescribed the morning sickness drug.

Chairwoman of the Association for Children Damaged by Hormone Pregnancy Tests in the United Kingdom Marie Lyon told NZ Herald Focus she had heard from numerous women who took Primodos since the evidence came to light.

Lyon took the drug, which came in the form of two small tablets, when she was pregnant with her daughter who was born without a lower arm.

She said it was shocking to see the evidence which showed the health authorities in the UK and Germany, as well as the manufacturer, were aware of the issue.

Lyon said the organisation was considering taking legal action against the health authority and drug company.

According to the documents, a principal medical officer for the British Government discovered in 1975 that women who took a hormone pregnancy test had a "five-to-one risk of giving birth to a child with malformations".

The medical officer alerted the drug's German manufacturer, Schering, which was bought by Bayer in 2006, so it could address the problem.

The drug was not removed from the market for another three years.

The archived files showed that the officer destroyed materials which he used to make his findings "to prevent individual claims being based on his material".

The Telegraph reported that Bayer had rejected any suggestion Schering had concealed any information. It also rejects any links between the drug and birth defects.