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Scientists map use of epilepsy drug in England and Wales linked to birth defects | Medical research

Scientists have created a unique map of England and Wales that reveals detailed differences in the use of single drugs. The drug, sodium valproate, is a treatment for severe epilepsy but is also known to cause health problems for pregnant women.

Although the findings show that use of the drug is declining in response to warnings about its effects, the map shows clear differences in dispensing patterns for women of childbearing age, with rural areas in the North West It has been revealed that the highest percentage is seen in local governments. and throughout the eastern coastal region. The researchers cautioned that these fluctuations highlight underlying inequalities that require further investigation.

Valproic acid is an important drug in the treatment of epilepsy and bipolar disorder, but it has also been linked to miscarriages, birth defects, and conditions such as ADHD and autism.

In 2016, the medicines regulator MHRA announced that infants exposed to sodium valproate in the womb had the following symptoms: High risk of severe developmental disorders. It is estimated that around 20,000 children in the UK have suffered life-changing injuries from valproic acid. Additionally, research suggests that children of men who take this drug are at increased risk of neurological disorders.

“This is the first time we've been able to combine a range of health data to understand how a particular medicine is used within a population,” said the study team leader and director of clinical pharmacology at the University of Liverpool. said Richa Sofat, professor of therapeutics. . “The fact that we were successful suggests that health services can benefit from understanding at a detailed level how people in different regions use medicines.”

Valproic acid was chosen for study because of recent concerns about its use. “It's a balance between neurological issues and pediatric issues,” Sofat says. “If a pregnant patient with epilepsy is resistant to all other drugs except valproate, there is a clear problem for doctors. What is needed is a comprehensive view of who is taking valproate and where. We realized that.”

The team, supported by Health Data Research UK (HDR UK), claim that the project is also important in demonstrating the power of data-driven research. By combining separate national datasets, it is possible to get an overview of how different medicines are used across the country. The potential for this use of data science is amazing.

One future use would be to link anonymized maternal health data to the child's health records, increasing doctors' knowledge of how drugs administered during pregnancy affect fetal health. “That's probably true,” said Dr. Caroline Dale, another team member. University of Liverpool.

“Pregnant women are often excluded from traditional research methods such as clinical trials because of understandable concerns about unknown risks,” Dale says. “This means there are significant gaps in knowledge about the outcomes of safe drug use in this group. Our data-driven approach is non-invasive and can improve maternal health outcomes during pregnancy. It can be expanded to provide a deeper understanding, and tying this to the child's health records can help understand the real-world effects of medications.”

It should also be possible to monitor changes in prescribing of other drugs and uncover variations in the number of different drugs people may be taking in different regions, the researchers said. The research results are outlined in a paper published in the same journal. BMJ Medicine this week.

To carry out the study, scientists at the British Heart Foundation Data Science Center, supported by HDR UK, were given permission to use anonymised NHS health records, including primary care and hospital records, and then , was linked to the dispensing record for the drug in question, sodium. Valproic acid. This was the first time such data had been combined in this way.

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According to the study, from 2019 to 2023, new uses of sodium valproate will increase between 7 and 5 cases per 100,000 women aged 15 to 19 years, 11 to 7 cases per 100,000 women aged 20 to 29 years, and 14 cases per 100,000 women aged 30 to 39 years. The number of cases decreased to ~7. .

During the same period, the pregnancy rate per 1,000 women treated with sodium valproate decreased from 6.0 to 5.2. There was no evidence of an increase in epilepsy-related deaths among women aged 15 to 49 years between 2015 and 2022, but evidence of a slight increase among men between April 2018 and December 2022. There were several.

“These are amazing discoveries in and of themselves,” Sofat said. “While these studies show that there was a generally encouraging response to warnings about the risks associated with taking valproic acid, these warnings do not appear to be shared equally across the country. is.

“But at the same time, importantly, by providing access to a variety of anonymized health databases, we can gain insight into how medicines are used and help doctors make all sorts of improvements to the way they dispense medicines.” This could have significant benefits for health services.”

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