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To date, they have been notified 24 cases of suspicion of adverse effects related to malformations or neurodevelopmental disorders in children with ingestion during pregnancy valproate, a drug against epilepsy and bipolar disorder, "appears as a suspect drug".
That's what he emphasizes the government in response to a written question from the member United, we can share the tide, Eva García Sempere, on the revision of the drug evaluation protocols, as well as on the data and measures of assistance to the persons concerned by this medicinal product, whose trade name is Depakine.
The drug is indicated for bipolar disorder and certain types of epilepsy and, in both cases, it is indicated that administered only to girls or women in case there is no other alternative. For bipolar disorder, in addition, its use is contraindicated during pregnancy.
For some types of epilepsy, Valproic acid or valproate is the only alternative treatment and "not treating women carries serious risks to their health and that of the fetus," said the government.
In his response, the executive informed that the risk of birth defects has been known for years, as indicated by the technical data sheet and the prospectus of the drugs containing this active ingredient.
However, it is stated that "The study of neurocognitive disorders in children exposed during pregnancy is complexbecause it is difficult to control all the factors that may influence the child's subsequent development, combination therapy and the retrospective nature of the studies ".
In order to maintain active surveillance of the current situation, the Spanish Agency for Medicines and Health Products (In time) conducts a weekly review of suspected cases of congenital malformations and developmental disorders associated with valproic acid recorded in the database Fedra (Spanish pharmacovigilance, data on adverse reactions).
Since 2012, two "exhaustive" journals have taken place. The first ended in 2014 and the second a few months ago. After the first revision, the technical data sheet and the package leaflet of the medicine have been modified "very extensively" and elaborated. , by the time, an informative note for health professionals, also available on its website.
At the same time, the laboratory holding the marketing authorization was obliged (Sanofi) to write a letter to health professionals, specific documents have been developed for them and an information leaflet for patients. Similarly, a legend has been included in the cardboard packaging of drugs.
With the latest revision is launched a plan to prevent pregnancywith new documents, including a risk awareness form to be signed by the woman and her doctor, to ensure that the patient receives all the information on the dangers if she takes valproate during pregnancy, the government notes .
In addition, a pictogram will be added to the medication box with the caption to highlight the message. Until now, according to the government, Les Temps do not have any record indicating that there has been a complaint in court.
Last March was presented in Spain the Victims Association of Valproic Acid Syndrome (Avisav), whose lawyer, Ignacio Martínez, estimated in 10,000 affected by this medicinealthough there are no official documents.
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