Primodos; MHRA Call for evidence

 

On the 25th March 2015 the Medicines and Healthcare Products Regulatory Agency (MHRA) issued a call for evidence to assist with the independent review of all relevant documentation relating to Primodos www.gov.uk/government/consultations/hormonal-pregnancy-tests-call-for-evidence .

It has invited all interested individuals and organisations to provide any information they consider relevant to a possible association between the use of oral hormonal pregnancy tests and adverse effects on the pregnancy and the child.

All documentation must be forwarded to them by the 30th June 2015.

Examples of relevant evidence include;

  • Any unpublished information from clinical trials, observational data or other scientific studies relating to the effects of use of HPTs in pregnancy or on the developing fetus
  • Citations for published information from clinical trials, observational data or other scientific studies relating to the effects of use of HPTs in pregnancy or on the developing fetus
  • Published or unpublished information on the outcome of intentional or inadvertent exposure to progestogens and estrogens (at any dose) during pregnancy
  • Any evidence of the impact of local or national restriction or withdrawal of HPTs from use, particularly in relation to the incidence of birth defects

Yellow Card Reporting Site

The MHRA are encouraging people to use the yellow card reporting site; http://www.mhra.gov.uk/yellowcard to send to them as many details as possible regarding your experience with HPTs.

All reports should be made by the 30th April 2015.

If you have been affected by this drug we would encourage you to report your experience via the yellow card warning system.

We at Gregory Abrams Davidson Solicitors already represent a number of victims. Should you require any legal advice and assistance please do not hesitate to contact our specialist team on 0151 733 3353 or complete our online contact form and we will contact you directly.