A drug that helps control epileptic seizures has been reportedly linked to birth defects and should not be used by pregnant women or women of child-bearing potential.
Depakote was created by French pharmaceutical drug company Sanofi back in 1967. The British equivalent, Epilim, has been available since 1973.
The drug has been used around the world and has gained regulatory approval for treatment of epilepsy, with variations of the drug introduced in 1995 for bipolar manic episodes, and in 1996 to prevent migraines. But, a generation later, it has been revealed the drug can cause severe birth defects at a significantly high percentage.
Also known as Divalproex Sodium and Valproic Acid, it contains a reportedly dangerous drug called Valproate that, according to Drug Watch, had been “linked to suicide, liver toxicity, pancreatitis and a variety of birth defects“.
Worryingly, Sanofi’s drug characteristic profile of Depakote apparently noted damage to foetuses in testing the drug in both animals and humans.
Common side effects complained by users are:
- Tiredness
- Slow mental process
- Nausea and sickness
- Tremors
- Hair loss
- Weight gain
Women using the drug are said to be significantly more likely to develop Polycystic Ovarian Syndrome and grow cysts in their ovaries, adversely impacting their ability to become pregnant. More serious side-effects include having and acting on suicidal thoughts, liver damage and pancreatitis.
Even more concerning perhaps is the effect the drug reportedly has on foetuses.
Here are some of the reported birth defects:
- Spinal cord and brain damage
- Malformed limbs, skulls and brains
- Facial malformation, mostly cleft palates
- Heart defects
- Genital defects
- Extra fingers and toes
- Defects to cognitive ability affecting reasoning, intelligence, problem solving
- Autism
And what are the chances of getting these side effects? Reportedly, very high…
The statistics as provided by the European Medicines Agency in November 2014:
- 40% of children whose mothers were pregnant with them and took the drug suffered adverse neurodevelopmental symptoms
- 80% of the children had facial deformities (cleft palates)
- 11% had a physical malformation; a huge number compared to the 3% presented by the general population
How many people are affected?
A huge number of families.
French newspaper Le Canard Enchaîné reported that a suspected 10,000 women took the epilepsy drug whilst pregnant between 2007 and 2014. From those women, they think 450 children were born with defects, but some experts think the number is much higher: potentially even tens of thousands children.
Apparently, a similar number of pregnant women took the drug in the UK within the same time frame.
Now, experts recommend that the drug must not be used unless absolutely necessary. Doctors must actively warn women of the adverse risks and the extent of the risks so they can make an informed decision. Should the drug be prescribed, the users should be closely monitored; their physical and mental health constantly checked and blood tests to be taken as necessary.
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