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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: 0) by Anonymous Coward on Saturday April 22 2017, @06:21AM (3 children)
Those are easy to fix, aren't they? Means more money for the medical-pharma-insurance complex.
Now of course, cannabis seems to be effective for epilepsy and migraine. Can we get a study on cannabis-related birth defects? I'd hate just to extrapolate from a long pattern of cannabis being safe and effective for a number of problems, especially since cannabis has a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision
according to big pharma who certainly must know best because they're rich. Let us thank our benevolent government for following the wise advice of big pharma and keeping a dangerous weed like cannabis illegal.
(Score: 0) by Anonymous Coward on Saturday April 22 2017, @08:57AM
Can we get a study on cannabis-related birth defects?
That study already in progress. Results in 10-20 years when the data is analyzed.
(Score: 2) by Magic Oddball on Saturday April 22 2017, @10:53AM
The conditions mentioned would cost medical insurers money, and most of them aren't treated with prescription medication.
Also, out of the many migraines I've had, the absolute most vicious by far were the few triggered by marijuana exposure.
(Score: 0) by Anonymous Coward on Saturday April 22 2017, @05:04PM
Did you read TFS?
The pharmaceutical company informed the regulatory agencies of the problem.
Also, scientific references for your other claims would be appreciated.