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THE EPILEPSY MEDICATION valproate is responsible for “severe malformations” in 2,150 to 4,100 children in France since the drug was first marketed in the country in 1967, according to a preliminary study by French health authorities.
Women who took the drug during pregnancy to treat epilepsy were four times more likely to give birth to babies with congenital malformations, said the report, jointly issued by the French National Agency for the Safety of Medicines (ANSM) and the national health insurance administration.
“The study confirms the highly teratogenic” — that is, capable of causing birth defects — “nature of valproate,” said Mahmoud Zureik, scientific director of ANSM and a co-author of the report.
“The figure of about 3,000 severe malformations is very high,” he told AFP.
The types of birth defects attributed to the drug included spina bifida — a condition in which the spinal cord does not form properly, and can protrude through the skin — as well as defects of the heart and genital organs.
The risk of autism and developmental problems was also found to be higher, and will be quantified in a follow-up report later this year.
An earlier estimate suggested that 30 to 40 percent of children exposed in the womb could suffer such disorders.
Risks known since 1980s
From 1967 to 2016, between 64,100 and 100,000 pregnancies in France were exposed to valproate, resulting in 41,200 to 75,300 live births, according to the report.
The vast majority of the birth defects occurred for women under treatment for epilepsy.
But starting in the late 1970s, valproate — marketed around the world as Depakine, Depakote, Stavzor and other trade names, and as Epilim in Ireland– was also prescribed in France to treat bi-polar disorder.
Bi-polar women taking the drug were twice as likely to give birth to children with major birth defects, the study found.
The lower risk compared with women treated for epilepsy probably stems from the fact that — for pregnant bi-polar women — doctors stopped prescribing valproate early in the pregnancy, Zureik said.
“The risk of severe malformation is limited to the first two trimesters of pregnancy,” said Alain Weill, a researcher at the French health insurance administration and a co-author of the report.
The risk of birth defects associated with valproate has been known since the 1980s, especially for spina bifida, which occurs 20 times more frequently in foetuses exposed to the medication.
But the drug can still be prescribed to pregnant women when all other forms of treatment for epilepsy fail. That ruling, however, was put in place only in 2015.
Valproate is sold in France under the brand name Depakine by pharmaceutical giant Sanofi, but is also available in generic forms. It is sold as Epilim in Ireland.
Inadequate warnings?
Some French families of children with birth defects born to women who took the drug while pregnant — grouped under an umbrella association called APESAC — have sued the company, claiming that it did not adequately warn about the risks.
“The number of victims is potentially huge,” said APESAC president Marine Martin, who says two of her children — a girl and a boy — suffered physical defects brought on by valproate.
“We need to take into account children with malformations and autism, as well as families that lost a baby due to treatment during pregnancy,” she told AFP.
Her association estimates a total of 30,000 to 50,000 victims — children and families included.
Gerard Bapt, a deputy in France’s national assembly and a board member of ANSM, welcomed the report.
“It now appears fundamental that valproate in all its forms should not be prescribed for women of child-bearing age,” he said in a statement. Medically necessary exceptions, he added, should be rare and accompanied by “mandatory contraceptive use”.
In a statement, Sanofi said it had been “totally transparent with health authorities.”
“We are aware of the painful situation confronting the families of children showing difficulties that may have a link with the anti-epileptic treatment of their mother during pregnancy,” the drugmaker said.
France was last hit by a major drug scandal in 2010, when it was revealed that the off-label use of a diabetes drug called Mediator for weight-loss could cause fatal heart problems.
The legal fallout from that episode is still unfolding.
We have the other extreme here. Damned if do. Damned if you don’t. The fact is heroin destroys families. They should of thought of that when selling the horrible stuff.
You’ll find that the majority, if not all, these inmates have come from broken homes and deprived communities where they sold drugs to survive. It’s nasty and yes they were part of the cycle that they themselves were trapped in but Obama is acknowledging that solution involve them; much in the same way Mo Molam knew the peace process in NI had to involve inmates in British prisons.
Why is Obama doing this at the end of his term instead of at the beginning? The US prison population stands at over 2million. That’s more than China has incarcerated. It’s almost 2.5 times more than Russia has in prison.
the vast majority of prisons in the US are privately owned, run foe profit and care more about the bottom line than society. barry is an actor..reading off a script and being told what to do, as badly as drugs have messed up parts of society unpunished white collar crime and the burden it has put on society has damaged it a lot more.
in america there is a prison industrial complex,,,,,,,,,,,,,,,,thats the problem.
here there are yobos with 17 previous convictions walking free and committing more serious crimes because the justice system is far to lenient on them. the legal system does not mind, its a big cash cow for them.
Obama is a good actor and that’s all. It is well established fact that since he took office his administration has refused more freedom of information requests than other other administration in US history. And if he gave two shits about ‘non-violent crimes’ then he’d have long arranged for Snowden to come home and would have intervened in the Bradley Manning case as he could have done at any time.
He’s a liar, and has done nothing but further liberalise US laws (which is why most of these guys are in prison in the first place).
Hilary Clinton is far worse than he and if she makes it in it’s bye bye US.
OK idiot. Restored pride to US after years of Bush’s wrath. A true statesman. Agree with you about Hillary though. I hope Sanders wins
Try making a point like an adult and I might respond to you. Other than that. Take a hike.
you just replied to him.
My heart is bleeding purple piss reading the sob stories.
If anything our Judiciary here could learn a thing or two from US Judges about sentencing and the whole US legal system.
Instead of having Solicitors and Barristers they have just one set Lawyers who deal with your case from start to finish. Where there is a dedicated Prosecution Service staffed by full time Prosecution Lawyers and a dedicated Public Defenders Office staffed with full time Defence Lawyers for those that would normally get free legal aid here. And then Private Legal Firms for those that can afford them.
Yes because there is so little crime in the US compared to Ireland.
Funny how you, a prison officer, propose following almost every part of the US save the mass privatization of prisons, wonder why that could be, oh right, self interest.
Wari.
Simply because Privatised Prisons have been shown time and time again to be an utter disaster in terms of security and staff safety. One only has to look at our nearest neighbour to see just how much of a bad idea they are and why the rest of Europe are not following suit. In reality they actually cost the state more than those under Government control in the long term.
I’m all for criminals doing time for their crimes especially violent or sexual crime but some of the sentences for carrying a small amount of drugs are ridiculous. Check out the segment John Oliver did on it, it’s a real eye opener. When I think of the idiot I was as a teenager, I would hate to go to jail for 15 years because of being on idiot.
I didn’t deal drugs! lol
If the sale of illegal substances was legalised and regulated then a lot of these places would see a massive reduction in crime as the people relying on the drug trade to make a living would be forced into tax-paying, gainful employment as they could not compete with a well regulated, safe industry. Also, not only would we gain the tax from the legal sale of drugs, it would be much easier to ensure the quality and safety of such substances as they could be tested in proper labs before being passed onto the public. It doesn’t take a genius to see that the head in the sand approach just doesn’t work. As long as there is a clear demand for drugs, there will always be people willing to risk everything to meet that demand for massive tax free profits.
In fact the Americans have the right idea here. Conspiracy to distribute heroin is no small crime. In my opinion 15 years is entirely appropriate. Crime must be punished harshly or we are all doomed.
They should do more about guns than 1000 year prison terms
How about maybe not dealing heroin. Heroin is a violent drug as is most other drugs. And yes that includes Weed. So just because the initial deal was violent… what we should let them away. The Americans have the right way. Full length senences for federal offences. If we could adopt there legal court room system this country would be a hell of a lot better off.
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Finding out you have HIV can be an incredibly shattering experience. And I think the reason for this is everyone is under the false assumption that the virus is not curable. Well, i totally disagree with this. I was diagnosed of HIV disease for the past 3 years, with the curiosity and search for a cure i came across a blog and i saw lot of testimony post from people making a reference to DOCTOR BOADI ABIODUN how he used his natural herbal medicine to cure them of their diseases Some testimonies was centered on;
*HIV (with a very low cd4 count)
*HEPATITIS B
*HERPES,
*ASTHMA,
*EPILEPSY,
*CANCER,
*INFERTILITY
*STAPHYLOCOCCUS…
I decided to give it a trial, though i never believed in herbal medicine but i was in a way convinced with the sort of amazing testimonies i saw online i decided to contact him, with the response he gave, He promised to prepare and send the “TATAHWE” Medicine to me. It was not up to a week after i placed an order, I got the medicine and he instructed me to drink the medicine for two weeks ( only evenings before bed) after which, I should go back to the hospital for a Re-Test. I followed his instructions and i discovered that my urine became yellowish for good two weeks so immediately i finished the medicine i went for the test the following week, it was very surprising i tested negative. I can’t thank dr Boadi enough, so I decided to promote him because he cured me from my disease, there’s no disease he can’t cure with his medicine. Please also spread the good news to others so that those with same illness can be cured.
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thanks for your audience and i hope you find help like i did.
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