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In France, roughly one in a thousand pregnant women take valproate, a drug used in treating epilepsy (brand name Depakine) and bipolar disorder (brand names Depakote or Depamide). According to a study [original source, French, BBC] released by France's drug regulator, the children of those mothers are at serious risk of being born with severe congenital malformations: between 2 (Depakote, Depamide) and 4 (Depakine) times more likely than the general population.
The drug, of pharmaceutical company Sanofi, has been sold in a number of global markets, including the US, China and the UK. In a number of countries, including the US, it is also being used in the prevention of migraine (see 4th para), according to the European Medical Agency (EMA).
The French study estimates the total number of victims at between 2,150 and 4,100 over the period the drug was sold in France, starting from 1967. A rough extrapolation based on population size only, indicates that there could be between 10,000 and 20,000 similar victims in the US. While the French regulator will release a detailed study on the congenital defects (neural tube defects, cleft palate) only in September, EMA already registered delayed walking and talking, memory problems, difficulty with speech and language, lower intellectual ability, increased risk of autistic spectrum disorder and a higher likelihood of ADHD symptoms.
Sanofi itself has warned since 2011 that the drug should not be taken during pregnancy. Both the US FDA, in 2013, and the EU's EMA, in 2014, have warned healthcare professionals that valproate sodium and related products, valproic acid and divalproex sodium, should not be prescribed to pregnant women or women who are trying to get pregnant, unless no substitute is available.
(Score: 2) by physicsmajor on Saturday April 22 2017, @12:28PM (1 child)
Seizures and bipolar disease are very serious. Controlling both is important at all times, but especially so while pregnant, because either one uncontrolled in the mother risks two lives. Valproate is actually one of the best drugs available to do this. Alternative options are almost uniformly worse from a risk to the fetus perspective.
Women who have these problems and are pregnant have no perfect options. One must understand the difference between relative and absolute risk to understand this kind of study. The absolute risk profile is low - very low - low enough it took a review of 50 years of data to find an effect. Relative to the also very low risk in a normal pregnancy, it's slightly higher. That does not mean the sky is falling. The majority of people on this medication should actually be reassured by this study - not frightened, potentially to the point of stopping the medication and risking two lives (much worse than this relative risk elevation).
(Score: 2) by quietus on Saturday April 22 2017, @03:00PM
For the period 2007 - 2014, 14,322 pregnant women had been taking valproate. Extrapolating this over a 50 year period -- 102300 pregnancies -- the percentage of pregnancies, under condition of taking valproate, resulting in congenital abnormalities lies between 2 (2150) and 4 (4100) percent.
The thing that is a bit worrying is the prescription of valproate in the prevention of migraine. Migraine is (or seems to me) not a life threatening condition, yet with a far larger number of people suffering from it. Could it be that valproate is, or has been, more widely prescribed in other countries, apart from France?