Pharmaceutical use during pregnancy resulting in premature births, birth defects, and massive costs to insurers

The European Medicines Agency will go over the evidence concerning the harmful effects of an epilepsy pill on unborn babies and decide if the warnings are sufficient enough. The drug, sodium valproate, has been connected to nearly 20,000 babies born with disabilities ever since its introduction in the 1970s, reported the DailyMail.co.uk.

Also known as Epilim, Convulex, Epival, and Episenta, the anti-epileptic and anti-convulsant inhibits seizures by stabilizing electrical activity in the brain. Through this, sodium valproate can be used to control all types of epilepsy, and has even been prescribed as a treatment for migraines and bipolar disorder. Its efficacy has made it one of the best options for women dealing with these conditions.

However, numerous women have come forward saying that they weren’t warned about the risks of taking the drug. Sodium valproate has since been found to increase the risk of severe birth defects; in particular, babies who were exposed to sodium valproate while inside their mothers’ wombs had a 10 percent chance of having physical abnormalities. Moreover, they have a four in 10 chance of having cognitive problems like autism.

Julie Marjot, a mother of four from Norfolk, said that doctors revealed the effects the drug had on three of her children only after her youngest was born.

“As time went by and we had more children, we saw more pediatricians, we saw [general practitioners], we saw midwives, we saw all of these healthcare professionals. Why did it take for me to have four children before somebody finally said, ‘That child looks like it has got sodium valproate syndrome’?” she said. (Related: Birth defects – could Epilim be the new Thalidomide?)

Marjot’s 21-year-old daughter, 11-year-old son, and seven-year-old daughter are but three of the 19,200 children in the U.K. who’ve been negatively impacted by sodium valproate. It’s been estimated that around 48,000 children were born to mothers on this drug since it first hit the market. This means that roughly 40 percent of those children developed mental or physical problems over the course of their lives. Furthermore, experts have predicted that 800 babies would continue to be affected each year.

In France 1,200 people have begun preparations to sue the manufacturer Sanofi of insufficiently warning women of the possible risks. The French government has expressed its support for the legal action and has set aside 10 million euros or $1,177,9450 as compensation.

On the outrage over sodium valproate, a spokesperson for Sanofi reached out to the DailyMail.co.uk and said, “It is critical that both the risks of continuing treatment and the risks of stopping treatment are discussed before planning a pregnancy. Sodium valproate is an important molecule that epileptic women continue to rely on, even today, to control seizures, to avoid a potentially fatal seizure during their lifetime, including during pregnancy.”

The cost of health problems in babies

Far from just being emotionally burdensome, the families whose children were born with physical or cognitive defects also tend to struggle financially. In the U.S. alone, it was recently discovered that employer-sponsored health plans on premature infants reached at least six billion dollars in 2013, and at least a quarter of the expenditures was spent on children with major birth defects. This was in spite of these children accounting for less than six percent of the recorded premature births.

“The contribution of this study is to start to tweak out the contribution of birth defects to that overall cost burden so we can start to prioritize efforts at prevention of both preterm births and birth defects,” said Norman J. Waitzman, a co-author on the study. “This is a multi-billion-dollar burden. In order to prioritize interventions, we have to have an accurate estimate of what the costs are and how those are broken down because often times interventions are tailored to specific populations.”

If the situation is like this in the U.S., one can only imagine how it must be in the U.K. The takeaway from this is that before any expectant mothers pop that pill, consider what its health risks could be. A moment of peace can cost you a lifetime that you may never get back.

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Sources include:

DailyMail.co.uk

ScienceDaily.com