We all remember the thalidomide scandal, a drug to relieve nausea during pregnancy very popular between the late 50s and early 60s that caused serious malformations to thousands of children throughout Europe. This tragedy aroused so much social alarm and outrage that the legislation was changed internationally to establish more controls on medicines.
Today, it seems that these mechanisms have failed, because we have to talk about valproic acid scandal, an active substance present in several medications to treat epilepsy, bipolar disorder and migraines that, prescribed to pregnant women, could have caused malformations to several thousand children in Spain, as well as in other countries.
What is valproic acid?
Valproic acid, also known as valproate or sodium valproate is an antiepileptic and mood stabilizer. It is a broad-spectrum medication that acts on the central nervous system. It is marketed in a hundred countries of the world under different trade names such as Depakine and its derivatives (distributed by the Sanofi laboratory in Spain) as well as Chrono, Epilim, Episenta, Epival, Depakote and Depamide.
It is one of the drugs banned in pregnancy (with risk D for the FDA). If taken during pregnancy, it crosses the placenta and increases the risk of babies having physical malformations, low IQ, learning difficulties and autism.
Serious malformations
The malformations caused by the valproic acid They range from spina bifida, cleft palate, cleft lip, heart disease and genital anomalies, among others. But apart from this risk (from 10.73% versus 2-3% of the general population), the use of valproic acid during pregnancy increases the risk of developing disorders such as:
- lower intellectual capacity
- limited language skills (to speak and to understand)
- memory problems
- autism spectrum disorders
- delay in walking and speaking
Fetal Valproate Syndrome
Many babies who are exposed to this medicine are born healthy and have normal growth and development. However, studies have shown that women who take valproic acid during pregnancy have a higher risk of having a baby with birth defects and other health problems. The little ones affected with this syndrome may have a characteristic face of this disease, the fetal valproate syndrome.
Faced with this bleak picture, the only plausible explanation for continuing to prescribe this medication should be ignorance. However, it causes outrage to know that the terrible Side effects of this pill have been known for decades.
Chronology of a disaster
As stated in this publication of the Fundació Institut Català de Farmacologia, the harmful effects of Depakine have been well known for four decades:
-At the end of the 80s series of cases of developmental delay had already been described in children of mothers treated with valproic acid during pregnancy.
-1999. In one study a risk of neurological development problems was observed ten times higher in the children of women who had taken valproate during pregnancy, compared to those who had taken other antiepileptic drugs.
-2000. In a consecutive series of children with fetal anticonvulsant syndrome and developmental delay, most had been exposed to valproate.
-2001. Of 594 children of mothers with epilepsy treated in a center in the United Kingdom, 30% of the children who had taken valproate during pregnancy needed special educational aids, compared with 3.2% of those exposed to other antiepileptic drugs. .
-2011. Among 210 children of patients with epilepsy from a registry in the United Kingdom, from nine months to five years of age, developmental delay was observed in 40% of those exposed to valproate, compared with 4.5% of those not exposed. Other studies indicate that children of mothers who took valproate during pregnancy appear to be more likely to receive a diagnosis of ADHD.
What the Spanish Medicines Agency says
It seems enough, right? Well, it is not until 2014, when the scandal had already erupted in France, that the European and Spanish Medicines Agencies recommend avoiding valproate:
"In girls and women with gestational capacity, valproic acid should not be used, unless another therapeutic alternative cannot be used and the conditions of the pregnancy prevention plan are met." The following year, this body modified the leaflet and the technical data sheet of the drug and in November 2017 issued an alert that warns that “it can cause birth defects and problems in the early development of the child if taken during pregnancy” .
This year they recognized that the measures had not been sufficiently effective to minimize the risks and updated the recommendations:
In the treatment of epilepsy: valproic acid should not be used in women with gestational capacity, unless another therapeutic alternative cannot be used.
On its website, this body is labeled Dekapine with a black inverted triangle, which means that it is subject to "additional monitoring." They are products under special surveillance by health authorities either because they are new to the market or because additional studies are needed to prove their safety or effectiveness.
Women taking this medication should be informed (through their doctors) of the consequences it could have for their children if they become pregnant. Thus the medical community is recommended to offer other treatment options or, in the event that Depakine is absolutely necessary, that women of childbearing age use an effective method of contraception. However, the information is late and not all affected. There are pregnant women taking this drug without having any idea of the problem.
What does Sanofi say?
For its part, Sanofi, the laboratory that markets the medicine has issued a statement in which it assures that, since the beginning of the 1980s, it has provided information on the risk of malformations in the fetus.
"As knowledge has increased around the risks associated with the use of sodium valproate, particularly during pregnancy, Sanofi has shown complete transparency with the Health Authorities and began updating the medical information for doctors and patients. Sanofi He has systematically reminded patients through the medication leaflet that, in case of pregnancy or in case of wishing a pregnancy, a doctor should be consulted to act accordingly. "
On the other hand, they also have enough information posted on their website describing the dangers of using Dekapine. However, you cannot say that it is at hand. No mention is made of the medication either on the official Sanofi website or in its news section. You have to enter the tab where a list of your products appears and click on the name to access it.
Those affected in Spain could be thousands
The first Association of Victims of Valproic Syndrome has just been created in Spain, which seeks to ask responsibilities of Sanofi, the company that sells the medicine, aid for those affected and, above all, stop prescribing to women of childbearing age and pregnant (yes, incredibly, it is still done). Families who think their children may be affected by Depakine can contact the Association to inform them about the steps to follow through the aforementioned website or also join their Facebook group.
The foundation has the support of Marine Martin, representative of the 5,000 families affected in France and who has in his book Dépakine, the scandal, How he discovered by chance that his six-year-old son's malformations (later learned that his eldest daughter was also sick) had a cause. He was surfing the internet. Instead of searching for "autism," as he used to do, he wrote the words "dangerous" "medicine" and "pregnancy" and came across the page founded by British families affected ten years ago:
"I just entered an English website. And then I get the blow: the boy in the picture is identical to my son. Stroke by stroke." He is my son, "I say to myself, sounded. Other images of children parade: they all look like cousins , they all look like my son. These children with a thin upper lip and a crushed nose have all been intoxicated by Depakine ... It is called "valproate embryopathy," or "anticonvulsant syndrome" ... I will never know what face there would be My son had been stolen, his identity was stolen ... Why have none of the specialists I crossed my health careers cited the possible relationship with me? Am I the only one whom my doctors did not notify? Why? Why? Why? ... "
Indignation is the strongest feeling that runs through families, especially mothers, when they discover that their children's problems could have been avoided. Babies and more has contacted Carmen Rosa Galán, mother of one of the affected children in Spain. She details the feelings of anger and guilt that invaded her when she learned that Dekapine had caused the disorder suffered by her 15-year-old son Victor:
"My son has Asperger's syndrome. I found out last year that it was due to the medication and I felt a great guilt because I didn't know that every time I took that pill while I was pregnant I was hurting my baby. Besides anger because my epilepsy was very mild, I could have left the treatment perfectly and my son would have been born healthy. "
Finally, in Spain today we do not know how many women are being treated with this medicine for epilepsy or bipolar disorder or how many of them could be pregnant or planning to do so without knowing the serious danger their baby is in. Nor is public health follow-up of children victims of this disaster. Not many parents are aware that their children's situation could have been avoided. The newly created association seeks justice for parents and information for the medical community and families that avoid more victims of valproic acid.
Dépakine, le scandale: Je ne pouvais pas me taire
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