The Spanish Agency for Medicines and Health Products (AEMPS), under the Ministry of Health, has reported the preliminary results of a study suggesting an increased risk of neurodevelopmental disorders in children whose fathers were treated with valproate, compared with parents treated with other antiepileptics (lamotrigine or levetiracetam) in the 3 months prior to conception.

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is evaluating the results of the retrospective observational study EUPAS34201 conducted in several registries in the Scandinavian countries (Denmark, Norway and Sweden).

According to the AEMPS, the study has certain limitations whose impact on the validity of the results is still unknown.. In this sense, he clarifies that the PRAC has requested additional information from pharmaceutical companies to assess the robustness of the data.

Pending the final conclusions, as a precautionary measure, the AEMPS recommends that healthcare professionals inform their male patients who are undergoing treatment with valproate of the existence of a study that is still ongoing whose data suggest that the use of these medications in the three months prior to conception, could expose the child to a possible risk of neurodevelopmental disorders. In this sense, it indicates to health professionals to assess the need to implement adequate contraceptive measures.

The AEMPS, in a statement, also reminds men or male adolescents who are undergoing treatment with valproate that “they should not interrupt treatment without first talking to their doctor, since the symptoms of their disease could reappear”. In the same way, it also recommends that patients assess with their doctor the need to implement effective contraceptive measures, as well as advises patients treated with the medication to notify their doctor if they intend to have a child soon.

Medications containing valproate and its derivatives are indicated for the treatment of epilepsy and as a second option in manic episodes of bipolar disorder.. They are marketed both in generic format and under the brand name Depakine (Sanofi Aventis).

Teratogenic effects in case of maternal exposure are widely known and there are preventive measures to avoid maternal exposure during pregnancy.. In 2022, Sanofi, the laboratory responsible for Depakine, was sentenced in the first instance in Spain to pay compensation of around one million euros to three families, after finding a relationship between the neuronal damage of three children and the consumption of this antiepileptic by of their mothers.

In 2014, a review of the benefit-risk balance of medicines containing valproate was carried out, motivated by the results of published studies that showed a risk of long-term neurodevelopmental disorders in children born to women treated with the medicine. (in up to 40% of cases), as well as its known risk of congenital malformations (in approximately 10% of cases). Following this review, its use was restricted and recommendations were established for girls, adolescents, and women with pregnancy capacity. However, in 2018 the conditions for its clinical use were further restricted.

Valproate belongs to a group of drugs used for the treatment of partial or generalized epilepsy; primary generalized epilepsy: convulsive (clonic, tonic, tonic-clonic, myoclonic) and non-convulsive or absence seizures; partial epilepsy: simple and complex seizures; secondary generalized seizures, and for the treatment of idiopathic generalized and mixed seizures and/or symptomatic generalized epilepsy (West and Lennox-Gastaut). In addition, it is a medication used in the treatment of mania in adults, one of the phases of bipolar disorder.

The EUPAS34201 study was registered in April 2020 in the European registry of post-authorization studies, the registry that includes the analyzes that are carried out after a certain drug receives authorization to market.

According to the data presented, this is an observational and retrospective study that is being carried out using data from the national registries of Norway, Denmark and Sweden.. Its objective is to examine a possible association between paternal exposure to valproate in the moments before conception with the risk of offspring developing neurodevelopmental disorders, including autism spectrum disorders (ASDs) and congenital malformations.. The study evaluates the effects of the drug in comparison with other antiepileptics, such as lamotrigine or levetiracetam.

The Covid-19 is leaving a new increase in cases in the middle of summer and experts predict that they will continue to rise for a few more weeks, although the vast majority are mild cases that are showing “some” in Primary Care, but hardly “nothing” ” in hospitals and even less in ucis.

According to the latest Sentinel Surveillance Report on Acute Respiratory Infections in Primary Care (IRAs) and in Hospitals (IRAG) Influenza, COVID-19 and other respiratory viruses published by the Carlos III Institute, in one week the incidence of covid-19 in Primary Care has increased 13 points, from 75 cases per 100,000 inhabitants to 88. At the beginning of July it was 29.

By age groups, the highest figures continue to occur in children under 5 years of age, who are over 180.

Meanwhile, the hospitalization rate stands at 2.04 (in the previous report it was 0.75), but with fluctuations at the end of June. The rest of the respiratory infections that the report analyzes until August 6, the flu and the respiratory syncytial virus (RSV), remain at basal levels in both areas.

Unlike these two viruses, Sars-Cov-2 “has never had a seasonal behavior,” stresses Salvador Peiró, a specialist in Preventive Medicine and Public Health from the Health Services Research Area of the Foundation for the Promotion of Research. Sanitary and Biomedical of the Valencian Community (Fisabio).

“We have had outbreaks every summer,” remarks the researcher, and “what is to be expected” is that from time to time, approximately every 5-6 months, which is when the protective effect of vaccines and natural immunity acquired after an infection begins to decline, these types of upturns occur.

If all this is added to the increase in mobility and social interactions typical of summer, the first of the last four that also takes place completely stripped of a mask, “because the upturns are sung.”

But with each contact, the immune system does not start from scratch as it happened at the beginning because it already knows the virus, although it can mutate and generate new variants, so what is foreseeable is that the peaks will be, “in general, calm”, like the that is taking place now.

This expert downplays the fact that the highest rate appears in children because, in addition to having much lower vaccination coverage than adults, they have a very mild disease.

However, he points out that today, the data is “difficult to interpret” because very few tests are carried out, and those that are carried out are self-diagnostic, not included in official statistics, which only count those that the health system performs on people over the age of 60.

Dr. Javier Arranz, a member of the Infectious Diseases working group of the Spanish Society of Family and Community Medicine (semFYC), agrees in stating that, “for now, the covid is not like the flu, a seasonal infection that we see in winter, but it has much more to do with social behaviour.

Holidays, meetings, festivals, crowds…. Social relations intensify in this period, for which reason Arranz predicts that cases will still increase “for a few weeks” and in “a few weeks” they will begin to decrease again.

In any case, the doctor emphasizes that “it seems that the infection continues to be of low severity because hospitalization rates fluctuate a lot, but they do not remain stable”, although he recalls that, as has always happened, the more cases, the more admissions, so it cannot be ruled out that in the coming days we will also see a rise in this indicator.

On this, Peiró abounds that this new summer upturn “is actually causing very few problems: in Primary Care they notice something, in hospitals practically nothing and in ICUs, nothing.”

Although we are all seeing how the infections are skyrocketing around us, practically all of them are mild, so it is not necessary to take special measures “beyond people with symptoms, it is better if they wear a mask and seek distance from the elderly or vulnerable “.

With them, the situation changes because their system is weakened, but this happens with all respiratory infections, not just Covid; For this reason, the more the virus circulation is contained, the more protected they will be.

Vaccines do not prevent contagion, but they do work “very well” in preventing serious disease; For this reason, the Fisabio researcher advocates a new dose of memory for the vulnerable population this fall.

The fact that it is in autumn is merely a logistical matter to make it coincide with that of the flu, but not because it is now expected that the Covid will adopt a seasonal behavior that until now it has not had.

Given that the variants that circulate have changed -the predominant one now in Spain is the XXB (33%), and in the season it has been the BQ.1 (32%) and the XBB.1.5 (31%)-, the ” sensible” would be to get a new injection with the most up-to-date vaccines prepared by Pfizer, Moderna and Novavax. The others, he insists, should focus on people at risk of developing severe covid, with whom extreme precautions must be taken.

So that in the event of any respiratory symptom, “it does not matter exactly whether it is covid, flu or syncytial virus, whatever it is, you must try not to infect it by adopting basic education and hygiene measures: distance and mask. And this must be forever, not because now we have a rebound,” concludes Peiró.

All of our history weighs on him, from the Greeks to the modern age, going through a significant medieval period, in which suicide was imposed as a sin.. Countless currents of thought have flown over it, and all disciplines have tried to understand it: sociology, anthropology, philosophy, medicine… It is known that in each of our civilizations taking one's life has its own nuances, from ancient societies in which voluntary suicide was accepted up to convictions related to it related to honor. For example, the suicide of the Japanese writer Yukio Mishima is well known, but also that Plato spoke out fiercely against taking his own life after his teacher, Socrates, voluntarily accepted a death by poison in Ancient Greece.

The result of this overwhelming residue is that, to this day, when Spain is facing alarming suicide figures, a large number of myths persist among us, in the form of set phrases that are sometimes said without thinking, and that make it difficult to problem solution. Meanwhile, professionals demand a national prevention plan that is equal in endowment to the fight against gender violence and traffic accidents. Some of these deeply embedded ideas among us are “if he says it, he doesn't do it”, “you don't talk about suicide”, “whoever takes their own life is because they are crazy”, “they just want to attract attention” or “you have to be very brave.”

But those who in our country work on this issue point out many more and, above all, the importance of dismantling them as a giant step when it comes to getting fewer Spaniards to feel so much anguish as to think about leaving. “Suicidal motivations are imbued with cultural influences. And we don't understand it the same in the West as in the East”, confirms Miguel Guerrero Díaz, clinical psychologist at the Marbella Community Mental Health Unit and head of the Cicero Suicidal Behavior Prevention and Intensive Intervention Program. As he explains, “the psychiatrization of suicide from the Enlightenment is decisive in the current vision we have of suicide.”

Guerrero is also the author of an analysis, Reflections on suicide from a historical perspective, published in the Psicoevidencias Bulletin in 2019, in which it is recalled that the motivations for taking one's life remain the same as thousands of years ago, and marks as important the publication in 1621 of the book Anatomy of Melancholy, by Robert Burton, “the first author to propose suicide as a result of an alteration”, “It represents a historical milestone as it is considered a true precursor of future scientific postulates of the 19th century. Burton cries out for tolerance and mercy for the suicide by stating that there is no demonic possession, but rather a melancholic temperament caused by an excess of black bile.”

Until, between the 19th and 20th centuries, the French sociologist Émile Durkheim (1858-1917) “thought of suicide not as an individual phenomenon but as a markedly social one.”. The social causes (economic crisis, poverty, isolation, social changes, excessive social regulation, etc.) and not the individual ones, originated the suicidal act”.

Pedro Martín-Barrajón, head of Emergencies of the Princess Psychologists 81 network, also points out that “outdated and obsolete ideas persist about suicide and mental illness that make their prevention difficult and even increase the damage to survivors”. Myths that are also still present among health workers and the medical community. “One of the real challenges is getting the majority of people to stop thinking that 'this happens to others' and not in ordinary families like ours,” warns this expert.. With them and others who work in the field, in addition to various investigations, we analyze the most common ones.

“If he says it, he doesn't do it” / “He just wants attention”

The emergency firefighter, specialist in suicide care, Sergio Tubío, says that “this type of assertion is a mistake”.. And that, before saying them, we should think that when “someone has suicidal ideation, they value death as a way to escape hopelessness and suffering”. In that distressing vital moment, “impulsivity arises, but also ambivalence”, that is, there is a kind of balance within one between “anchoring to life” and the need to flee from pain. Let what is good in that person's life win in the balance. “Our job is to get him out of that 'tunnel vision and give up the attempt,'” adds Tubío.

In addition, according to the study carried out among health professionals by Martín-Barrajón in 2019, Presence of myths about suicide in emergency and emergency professionals, it is known that 41.9% of emergency professionals answered that this statement was true”. On the contrary, “according to data from the Spanish Society of Suicidology, 18% of the patients who committed suicide had consulted their primary care physician the same day, 66% had done so during the last month and 75% in the last three months”. In addition, 60% asked for help during the last week. And close to 40% of primary care physicians are unaware of the suicidal history of patients, of which between 1 and 10 have suicidal thoughts and intentions.”

“You have to be very brave to commit suicide”

Guidelines on how to communicate and report suicide are very clear in this regard.. “Suicide is a source of suffering and is not related to moral values, nor model behaviors or that make the suicidal person someone to imitate.”

42.9% of the specialists who responded to the survey on myths about suicide prepared by Martín-Barrajón validated the statement, and this professional insists on the error of “attributing stable and permanent personality characteristics to suicide”. “The literature on suicidology shows that suicidal risk is much more universal, daily, and at the same time unknown, since 50% of the general (non-clinical) population will experience moderate-severe suicidal tendencies throughout their life. life,” he says.

“If he commits suicide, he is crazy”

The assumption that a person with suicidal ideation has a mental illness doesn't help either.. Pernicious statements such as “I would be sick in the head” or “Did I have depression? They are very frequent and popular,” says Martín-Barrajón. And specialists have already shown that “there is a weak association between psychopathology and suicide”. “For those who continue to doubt: you don't have to have a mental disorder to have suicidal behavior,” insists the Princess 81 expert. “No suicide genes have been identified,” he says. Related to this topic is what specialists call “definition bias”: “Thinking of suicide as the active search for death, when in reality it is a behavior that seeks to stop psychological pain”. That is to say, it does not help to persist in repeating that a person thinks about suicide because they want to die, being more appropriate to say other statements, such as that they suffer so much that they have come to think of taking their own life.

“If you've tried it once, you'll try it again”

Labeling people, and believing that someone who has attempted suicide will always be suicidal is also deeply rooted socially.. The more humanized care, support and accompaniment we do with these people, the more prevention we will be doing”.

“Suicide is not talked about”

Another of the myths that continues to cause the most damage is the belief that “talking about suicide can lead to it, or be a stimulus”. “Today we know that instead of encouraging suicidal behaviour, addressing it responsibly in the media or in individual interviews with patients at risk can give a person other options, or time to rethink their decision, and therefore prevent it.. Empirical evidence shows that asking or talking about suicidal behavior does not have negative consequences in the general population or in the clinical population.”

The same happens in relation to the publication of information about suicide.. The idea is already obsolete -it is clear- that talking about suicidal ideation infects the phenomenon. Now there is an emphasis on talking about it with extreme prudence and responsibility. “More than 20 years ago, the WHO provided style guides,” recalls Martín-Barrajón, “and a specific one was published in the Community of Madrid.”

In fact, “silence and occultism around suicide are one of the main stumbling blocks of prevention, and that interferes the most in requesting help, and in the possibility of being able to provide it, because what is not known is not prevented”.

“Suicide is a public health issue”

It is. But not only that: it is above all a social problem and one that we can all help reduce.. In this sense, regarding the presence of these myths among health workers, as mentioned, the Cicero Program specialist recalls that they are, after all, “people inserted in the same community with the same biases, myths, prejudices and erroneous beliefs”.. It encourages, yes, to establish “an exercise of conscious self-exploration, without blaming ourselves, because we have been educated that way”, in relation to what preconceived ideas we accumulate about suicide.

The Spanish Agency for Medicines and Health Products (AEMPS) warned this Thursday of the preliminary results of a study that suggest an increased risk of neurodevelopmental disorders in children whose male parents were treated with valproate in the 3 months prior to conception.

The study, noted the AEMPS, has certain limitations whose impact on the validity of the results is still unknown, for which reason the European authorities have requested additional information from the pharmaceutical companies that produce the drug to assess the robustness of the data.

What is valproate?

According to the Spanish Agency for Medicines and Health Products, medicines containing valproate and its derivatives are indicated for the treatment of epilepsy and as a second option in manic episodes of bipolar disorder.. There are 10 authorized presentations of these drugs in Spain, both in generic form and under the Depakine brand (Sanofi Aventis).

What should I do if I am a man and take valproate?

The health authorities indicate that if you are a man or a male adolescent and you are being treated with valproate you should not stop treatment without first talking to your doctor, as the symptoms of your disease could reappear.. The possible risks of the drug refer to the offspring, so the recommendation is to assess with your doctor the need to use effective contraceptive measures.. In the same way, it also recommends notifying your specialist of your intention to become a father if you are undergoing treatment with the drug.

Is there a risk also in women?

Teratogenic effects in case of maternal exposure to valproate were already known. In fact, there are preventive measures to avoid maternal exposure during pregnancy. In 2022, the court found a relationship between the neuronal damage of three children and the consumption of this antiepileptic by their mothers, for which reason the manufacturer of Depakine (Sanofi Aventis) was ordered to compensate the affected families.

Currently, the AEMPS establishes that valproate or valproic acid should not be used in girls and women with childbearing capacity, unless another therapeutic alternative can be used and the conditions of the established pregnancy prevention plan are met.. Likewise, it establishes that pregnant women should not use valproic acid in bipolar disorder and, in the case of epilepsy, it can only be used if no other therapeutic alternative is possible.. The pregnancy prevention plan includes the evaluation of the possibility of pregnancy in all women, and that the patient in treatment agrees to use contraceptives, undergo regular pregnancy tests and consult with the doctor in the case of planning a pregnancy or if it is she is pregnant. In addition, it is established that the treatment be reviewed at least once a year.

What risks have been verified in treated women?

Studies carried out show a risk of long-term neurodevelopmental disorders in children born to women treated with the drug (up to 40% of cases), as well as its known risk of congenital malformations (in approximately 10% of cases). the cases).

The arrival of cool northwesterly winds cooled northern Spain a bit on Thursday, but the rest of the country continued to scorch and we will continue to do so until at least the weekend, when the third heat wave we suffered this summer is expected to end. although temperatures will continue to be very high in almost the entire country.

As Rubén del Campo, spokesman for Aemet, explained, these same northwesterly winds arrive overheated in the Mediterranean area, the entire Levant and southern Andalusia, further increasing temperatures, especially in points of the Valencian Community and in the Region of Murcia.. Thus, the Valencia airport reached 46.8 degrees on Thursday afternoon, which is 3.4ºC more than the previous record, registered in 1986, in a historical series that dates back to 1966, according to Aemet on the network. social X (formerly Twitter).

Records were expected for Wednesday, considered the worst day of this heat wave, and according to Aemet, the one in the city of Soria was exceeded, which reached a maximum temperature of 38.9 ºC, an absolute record in a series that has 80 years old, beating the 38.7 registered in July of last year.

The early morning from Wednesday to Thursday was another night not to sleep. Seventy-five stations in the Aemet network recorded torrid nights, that is, they did not drop below 25 degrees. In towns in the East and South of the peninsula at 8 in the morning the thermometer had not dropped below 27 degrees. But there were places in the Canary Islands where they had to endure 30 degrees at night, such as San Bartolomé de Tirajana, on the island of Gran Canaria.

The Canary Islands will be from Friday and at least until Sunday one of the territories that suffers the most from the suffocating heat, since today their own heat wave begins, which will exacerbate the situation that they already began to experience yesterday, with the entry of air very hot from the Sahara and dust in suspension that will give rise to haze. According to Del Campo, the maximum will reach 37 -39 degrees in many parts of the Archipelago and will exceed 40 in the south of Gran Canaria, where the next few nights will also be very hot, as they will not drop below 30 degrees and it could be that they will reach 32 degrees night.

Today the maximum temperatures will drop in the Mediterranean area and will rise in large areas of the rest of the peninsula. It will be very hot, reaching more than 42 degrees in large areas of Andalusia and with a good chance of reaching 44 in the Guadalquivir Valley and in the province of Huelva.

For the weekend, says the Aemet spokesperson, “a temperature drop is expected on the peninsula and although the necessary thresholds may no longer be exceeded to be able to speak of a heat wave in peninsular territory, temperatures will continue to be high, especially the Saturday where there can be more than 40 degrees in the Guadalquivir valley, and 35 degrees in large areas of the interior, values in many cases between 5 and 10 degrees above normal”. On Sunday, few areas will exceed 40 degrees but 35.

According to Del Campo, the risk of fires will be very high or extreme these days in almost the entire country, also when temperatures drop, because we have been without rain for many days.

The Aemet spokesman also advanced the forecast for the bridge on Tuesday, August 15 for the feast of the Assumption of the Virgin: “We will continue with the heat of midsummer, a maximum temperature of 35 degrees in large areas of the east, center and south of the peninsula and in the Balearic Islands, about 32 degrees in the Northern Plateau and between 30 and 32 degrees on the Mediterranean coast, with a feeling of muggy there due to high humidity”. It will be cooler in the Cantabrian Sea, with 25 to 30 degrees. And for now, the forecasts suggest that as of Wednesday there will continue to be high temperatures and there will be hardly any rain.

Extreme weather wiped out Europe's first inhabitants, according to new research involving Spanish scientists. It happened 1.12 million years ago, according to this work published Thursday in the journal Science that challenges the idea of an early and permanent human occupation of Europe.

The oldest known hominin remains in Europe come from the Iberian Peninsula and suggest that the first archaic humans arrived from southwest Asia 1.4 million years ago..

The climate at this early Pleistocene epoch was characterized by warm, humid interglacial periods and mild glacial periods, so it has long been assumed that, once the first humans arrived, they were able to survive in southern Europe through multiple climatic cycles and adapt to increasingly cold conditions of the last 900,000 years.

However, now an international team led by researchers from University College London (UCL), the Institute for Environmental Diagnosis and Water Studies (IDAEA-CSIC) and the IBS Center for Climate Physics in South Korea, has discovered evidence of the appearance of hitherto unknown extreme glacial conditions around 1.12 million years ago.

Glaciations

“To our surprise, we discovered that the cooling was comparable to the most extreme events of the recent ice ages,” said Professor Joan Grimalt, a CSIC researcher at IDAEA, in a press release..

They hypothesize that this would have subjected small bands of hunter-gatherers to considerable stress, particularly as scientists believe early humans may have lacked adaptations such as sufficient insulation from fat, as well as effective clothing, shelter, or knowledge. to make fire.

To assess the impact of climate on early human populations, researchers at the IBS Center for Climate Physics developed a habitat suitability model that relates climate data to fossil and archaeological evidence of human occupation in southwestern Eurasia collected by researchers. from the Natural History Museum in London and the British Museum. “The results showed that the climate around the Mediterranean strayed far from the conditions preferred by early humans during the cold glacial maximum,” says IBS professor Axel Timmermann.

Taken together, their results suggest that the Iberian Peninsula, and southern Europe more generally, was depopulated at least once in the Early Pleistocene.. The apparent absence of stone tools and human remains for the next 200,000 years raises the intriguing possibility of a long-term hiatus in European occupation..

“If this is true, Europe may have been recolonized around 900,000 years ago by more resilient hominins, with evolutionary or behavioral changes that allowed survival in the increasing intensity of Middle Pleistocene glacial conditions,” says Chris Stringer, co-author of the study. and researcher at the Natural History Museum, London.