It disabled more than 20,000 newborns
Britain is still living through the teratogenic drug scandal
Janet Williams (right) her two children with horrific deformities.
From the source
Children disfigured after their mothers took thalidomide.
From the source
Sebastian suffers from disfiguring hands from the drug sodium valproate.
From the source
picture
Doctors revealed in 1973 that the drug sodium valproate, used to treat epilepsy, poses a danger to fetuses in the wombs of mothers, but they ordered the removal of warnings from packages warning pregnant women against its use.
After nearly 50 years of continued use by pregnant women with epilepsy, 20 thousand disabled children came into existence, and doctors still advise pregnant women with epilepsy to take it.
McNamara's ordeal
The moment she saw her newborn son, Sebastian, Catherine McNamara knew something was wrong.
His little hands were abnormally distorted and twisted, taking the wrong direction, and one hand without a thumb.
At first, she and her husband tried not to panic when their baby was taken for x-rays and tests.
"We thought what happened to the child could be fixed," she said.
But a few days later, the couple panicked when doctors told them that Sebastian's malformations were permanent, caused by the medication McNamara was taking to control her epilepsy.
McNamara broke down in tears.
"I felt so guilty, all I could think about was, 'Why did you do all this to my son?'" she says.
Like thousands of women, McNamara learned from her doctor that the epilepsy drug, sodium valproate, is safe during pregnancy.
"They told me everything would be fine," she said.
By the time her son was born in 2012, several warnings had been issued over the decades that the drug was unsafe for pregnant women.
High risk of not warning
The drug, which women with epilepsy have been taking for decades without proper warning, has caused up to 20,000 children in Britain to develop autism, learning difficulties and physical deformities.
Despite a 2020 report criticizing the failure to inform pregnant women of its risks over four decades, doctors do not properly warn pregnant women about these risks.
According to the latest data published in March, 247 pregnant women were prescribed sodium valproate, between April 2018 and September 2021. As a result, around six babies are born with malformations every month in the UK, after being exposed to this drug.
An investigation by the Sunday Times newspaper revealed that the drug is still being distributed to women in simple packages, without a leaflet showing information about it, or warning labels.
The government is refusing to provide any compensation to those affected by sodium valproate, despite an independent review by Tory MP Baroness Kumperleg, which concluded in 2020 that the families should be awarded financial compensation.
Former Health Secretary Jeremy Hunt says doctors must now be banned from prescribing the drug to pregnant women, and families affected by it must be adequately compensated.
He compared the case to the scandal of thalidomide, an anti-morning sickness drug, which caused malformations in thousands of children after it was licensed in the United Kingdom in the 1950s.
When sodium valproate was licensed as a new epilepsy drug in the 1970s, the British medical community was beset by a similar scandal, as hundreds of children were born severely deformed after pregnant women were given the drug thalidomide.
There is increasing evidence that sodium valproate causes not only physical abnormalities, but also neurological problems.
A major study in the United Kingdom and the United States in 2009 confirmed that drug use during pregnancy can harm children's IQs, and the higher the dose, the greater the harm.
Failed lawsuit
More than 100 families have tried to sue Sanofi for damages to their children, but the lawsuit collapsed just three weeks before the trial was due to start over the withdrawal of legal aid.
Janet Williams, who was supporting the families who brought the case, despaired as she and her husband struggled with their two severely disabled sons, Lee and Philip, and the couple desperately needed financial help to care for their two sons.
"We never knew why the case failed."
As part of a legal settlement to avoid having to pay costs, the parents were forced to sign an agreement committing themselves not to sue again in the same matter.
After the legal case failed, Williams was determined to continue making public the effects of sodium valproate on her two sons.
As geneticists and pediatricians became increasingly convinced of the problem, their concerns did not reach the ears of neurologists who were already prescribing the drug to pregnant women with epilepsy.
Few of these physicians read journals dealing with genetic dilemmas.
As a result, the drug continued to be distributed to pregnant women.
Among these women is Patricia Alexander, who was advised by her doctor to continue taking a high dose of 2,000 mg per day throughout her pregnancy with son Joseph in 2000, and again in 2009, when she was waiting for her daughter, Amelie.
During her medical appointments, she repeatedly asked if the drug was safe, and each time the specialist doctors and nurses allayed her concerns.
"I had no idea about valproate syndrome, and no doctor had mentioned it to me before," she says.
I learned about the dangers of the drug from “Facebook”
Both Joseph and Emily were born with physical disabilities, and both were confirmed to have autism.
Alexandre learned of fetal valproate syndrome only years after the birth of her two children.
"The first time I knew him was when I read a survey on Facebook," she says. "It was painful for me after I found out. Every difficulty my children faced was mentioned in this survey, and it was attributed to sodium valproate."
To this day, her two children are completely dependent on her and her husband.
Amelie is walking on crutches due to a sprained leg that may require surgery.
Joseph is also unable to stand or walk normally.
"No one can feel our pain unless they live our lives," Alexander says. "No one knows how hard my husband and I are during the day."
A lawsuit against the manufacturer
Despite all this, the British government refuses to compensate the stricken families.
In July 2020, then-Minister for Patient Safety, Nadine Dorries, offered a candid apology to the families, saying she was "shocked but incredibly angry after reading the horrific report", but offered no financial compensation.
The French government has already established a fund dedicated to compensating victims.
Sanofi is facing a class action lawsuit in France, where more than 30,000 children are believed to have been affected since sodium valproate was licensed there in 1967. In January a court ruled that the company "was at fault for failing to meet warning and reporting requirements".
Sanofi says it has fulfilled all its obligations in the UK, where between 9,000 and 20,000 children may have been harmed more by sodium valproate than by thalidomide in the 1960s.
A spokeswoman expressed her "sympathy to anyone who has been affected by exposure to valproate during pregnancy and their family members," but added: "Sanofi has fully complied with its regulatory obligations with respect to valproate, including providing product information to healthcare professionals, professionals and patients, but does not You think there is any strong justification for paying compensation.”
safety measures
A NHS spokesperson said the agency had set up an expert group to help reduce the use of sodium valproate by 50% next year by women of childbearing age, and that it had alerted all women and girls aged 12 to 55 in England who were taking the drug, to remind them of the risks. .
However, the Medicines Regulatory Agency acknowledged that the warnings had not yet reached the intended people.
Medicines and Healthcare products Regulatory Agency's chief safety officer, Dr. Alison Cave, says work is continuing on the safe use of sodium valproate and reducing prescriptions.
She says the agency is now working to ensure the medication is dispensed in the original packaging with safety information inside.
She also says, "If there are cases where this information was not provided, we will investigate."
She adds that the drug "should not be taken by anyone of childbearing age unless they have a contraceptive programme, which includes the use of effective contraception."
She also emphasized that women using sodium valproate are now required to sign annual risk acknowledgment forms with their health care professional, "as their circumstances may change in relation to the risk of pregnancy."
• Despite a 2020 report criticizing the failure to inform pregnant women of its risks over four decades, doctors do not properly warn pregnant women about these risks.
Follow our latest local and sports news and the latest political and economic developments via Google news