Public call for evidence launched relating to the use of hormonal contraceptives
The Medicines and Healthcare products Regulatory Agency (MHRA) has today launched a public call for evidence relating to the use of oral hormonal pregnancy tests (HPTs, which are no longer prescribed in the UK) and adverse effects relating to pregnancy including possible birth defects.
HPTs such as Primodos were available in the 1960s and 1970s and were widely used to diagnose pregnancy. In 1967, a study raised initial concern that use of HPTs may be associated with birth defects. The then Committee on Safety of Medicines (CSM) kept this issue under review and in 1975 recommended that in view of the possible concern, and the availability of alternative methods, doctors should not use HPTs. These products were withdrawn from the market in the late 1970s.
In October 2014, the government committed to an independent review of the evidence relating to HPTs and the possible risk of birth defects. The review is not a political inquiry intended to demonstrate liability, but to examine the evidence to assess whether there are grounds for accepting a link between the use of HPTs and the conditions experienced by some patients.
A group of experts in relevant scientific disciplines is currently being convened to conduct the review, which is expected to be completed by the beginning of 2016.
To ensure all the available evidence is reviewed, the MHRA is currently in the process of obtaining all relevant documents. As part of this process, the MHRA is asking any individual or organisation with information they feel is relevant to submit it for consideration by the experts during the review. All evidence submitted will be included in the review and a report (including a public summary) will be made publicly available once the review is complete.
Dr June Raine, the MHRA’s Director of Vigilance and Risk Management of Medicines, said:
“We encourage people to send us any information they consider is relevant to previously used hormonal pregnancy tests and potential adverse effects that they think may have been associated with these drugs.
“It is important that we hear from people who feel they or their child have been affected adversely by hormonal pregnancy tests. We encourage anyone who wants to provide information about a suspected adverse effect from use of a HPT to submit it to us via a Yellow Card report.
“We would also welcome any other published or unpublished evidence you consider relevant and wish to submit for the review and ask that you send this to us by the end of June 2015. ”
Medicines regulator launches call for evidence on previously licensed oral hormonal pregnancy tests, MHRA press release, 25 March 2015.
Campaigner Marie Lyon, chair of ACDHPT is interviewed by STV News
Parents who believe a pregnancy drug is linked to severe disabilities in their children are calling on the Scottish Government to help them in their fight for answers. Campaigner Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Tests (ACDHPT), is interviewed by STV News.
Sarah Rainey spoke to some people affected by Primodos, investigated and reported the long history behind the claims and counter-claims…
As MPs meet last May to discuss allegations that Primodos, a hormone pregnancy test, is to blame for birth defects that have devastated lives, Sarah Rainey spoke to some of those affected, investigated and reported the long history behind the claims and counter-claims.
Please find Hugh Easton‘s article introduction as “guest post” :
” This article is about a drug called Primodos, basically a high dosage version of the same artificial hormones as are used in contraceptive pills. Bizarre as it sounds, from 1958 to 1974, giving a woman Primodos (or the German equivalent Duogynon) was the standard method used in the UK and a number of European and Commonwealth countries for determining whether she was pregnant or not. Exposure to Primodos generally occurred during the time organogenesis and limb development were taking place, the same part of the pregnancy where exposure to thalidomide causes deformities. The result is that it appears to have caused similar deformities to those that occurred as a result of thalidomide. Several hundred thousand pregnant women in the UK were being given Primodos annually prior to its withdrawal in 1974, so even if it only caused deformities in a few percent of cases, the number of babies affected must have been quite large. Nonetheless, the whole thing’s been swept under the carpet.
One of the things mentioned in the documentary about Thalidomide I linked to a few weeks ago, is that most of the approx. 2000 thalidomide babies born in the UK were euthanized by the NHS, so that only 400 survived beyond infancy. Probably the same thing was going on with Primodos babies, and has gone a long way towards concealing how bad the deformity rate actually was.
Sexually dimorphic development doesn’t start until about 6 weeks after conception, and it appears that most exposures to Primodos must have happened earlier than that, so intersex-related abnormalities aren’t a major issue among Primodos victims. However, reading through the comments for this article, it appears that there’s at least one case where a male baby exposed to Primodos went on to experience many of the same difficulties commonly experienced by DES sons – hypospadias, undescended testes, incomplete masculinisation and gender dysphoria. ”
Many women have to take medicines while pregnant. But could they be risking the health of their unborn child? Decades after the Thalidomide scandal shocked the world, Panorama reveals how another medicine has damaged far more children. Drugs cannot be tested on pregnant women for ethical reasons, so doctors do not know if most prescription drugs are safe for the unborn child, and the system set up to monitor side-effects appears to be flawed. As evidence emerges that some common antidepressants are linked to heart defects in babies, the programme asks how much we really know about the safety of medicines women take while pregnant
The program is very interesting but unfortunately does not mention the DES drug tragedy. Once again DES is ignored. WHY? It would have been such a great opportunity. What’s wrong with DES? Is it because with DES, the Media can’t show upsetting photos of children born with no arms or legs like the victims of Thalidomide, or newborn babies who have undergone traumatic heart surgery because of the effects associated with the antidepressant drug their mum took during pregnancy? Is it because DES is the very first drug scandal which should have prevented many others to happen? All victims of drugs prescribed during pregnancy should join forces! The stories are all the same and highlights the same failure of our health system and the government response to the devastating consequences of these drugs. DES, Thalidomide, epilepsy drug Epilim, antidepressants … how many more victims are needed to put in place safeguards to protect mothers and their unborn child?