Published: 11 May 2017
Updated: 26 October 2017
Publications
Hormonal Testing Preparations
The Ministry of Health and Medsafe are aware of public interest around the product Primodos and any other systemic hormonal testing preparations previously available in New Zealand.
Any indications that a medicine may have caused serious adverse effects are treated extremely seriously by both the Ministry of Health and Medsafe.
As recent international reports have related to a period dating back up to five decades ago, the Ministry has been working through its archival files to establish the specifics of use for these products in New Zealand.
We have established that:
- Primodos first appeared in New Ethicals in 1966 - suggesting it was available and prescribed in New Zealand from that time.
- Minutes from the Drug Assessment Advisory Committee in 1975 recommended that Primodos should be withdrawn from the market in New Zealand. This was due to "reports received from overseas that birth defects have occurred when hormonal pregnancy tests have been taken in early pregnancy".
- In May 1975 the then Department of Health issued a clinical services letter advising that it was withdrawing systemic hormonal testing preparations for pregnancy testing from the New Zealand market. It did not specifically identify Primodos.
- The NZ Department of Health requested the company withdraw Primodos from the market in June 1975.
- A recall letter was sent by the Pharmaceutical Manufacturers' Association to wholesalers, retail chemists, public and private hospitals according to the Department of Health's recall code of the time.
- The recall was the responsibility of the drug companies marketing the preparations.
- There is no information on how many patients were prescribed this product. Medsafe has contacted Bayer to obtain information if it is available however the company has advised it unable to do so at this time.
- Amenorone Forte was another hormone based pregnancy testing preparation available in New Zealand. It first became available in 1968 and was withdrawn at the same time as Primodos, in June 1975.
During this process, we have been encouraging women who may have experience of being prescribed hormone-based pregnancy testing products such as Primodos to report their concerns and we have also been working closely with the Centre for Adverse Reactions Monitoring (CARM) in Dunedin.
For more information read Your Guide to Adverse Reaction Reporting - Medsafe website.
Any concerns can be reported directly to the Ministry, and can also be referred to CARM for reporting of possible adverse events.
Additionally, it's important to acknowledge that the international information surrounding Primodos is currently being formally reviewed by a working group in the United Kingdom.
Medsafe and the Ministry of Health will be following that review closely to learn what implications there might be for women who may have received the product in this country.
Through its memorandum of understanding with the Medicines & Healthcare products Regulatory Agency (MHRA), Medsafe can receive information directly from the UK regulator.
Medsafe is also happy to make available to the working group any and all information from New Zealand which may be useful.
We'll continue to provide updated additional information as it becomes available and would advise any members of the public who may have specific concerns about Primodos to contact Healthline, phone 0800 611 116, or email the Ministry on info@health.govt.nz
