Published: 20 March 2017

Publications

Primodos

The Ministry of Health and Medsafe are aware of public interest around the product Primodos.

Any indications that a medicine may have caused serious adverse effects are treated extremely seriously by both the Ministry of Health and Medsafe.

As the current reports relate to a period more than 50 years ago, the Ministry has been urgently working through its archival files to establish the specifics of use for Primodos in this country.

Today, we have established that

• Primodos first appeared in New Ethicals in 1966 - suggesting it was available and prescribed in New Zealand from that time.  
• 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  
• There is no information on how many patients were prescribed this product. Medsafe has contacted Bayer to obtain information if it is available.  
• Minutes from the Drug Assessment Advisory Committee in 1975 recommended that Primodos should be withdrawn from the market in New Zealand.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".  
• The NZ Department of Health withdrew Primodos from the market and removed stock from pharmacies in June 1975.

We have also searched for any files which may be held by the Centre for Adverse Reactions Monitoring (CARM) in Dunedin.

http://www.medsafe.govt.nz/profs/PUarticles/ADRreport.htm

CARM has been operating since 1965 so if adverse reports relating to a product such as Primodos had been received, we would expect them to have been held there.

• CARM has not received any reports of foetal malformations associated with the use of Primodos.
• CARM has received one report that described an adverse reaction in an adult only.

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 - 0800 611 116 - or email the Ministry on info@health.govt.nz

Medsafe has a memorandum of understanding with the Medicines & Healthcare products Regulatory Agency (MHRA) in the United Kingdom and will receive any relevant information from its review as it becomes available.

BACKGROUND INFORMATION

Primodos was a hormone based preparation containing norethisterone and ethinylestradiol.

ENDS