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Los datos definitivos no estarán disponibles hasta abril, pero la estimación ha sido confirmada por la portavoz de la agencia, Laura Alvey. Supera la marca de 370.887 informes de "efectos adversos" correspondiente a 2003.
Desde la FDA se atribuye esta evolución al incremento en el uso de fármacos de prescripción, más que a un aumento del riesgo de los fármacos en sí mismo. Los laboratorios han sido requeridos para informar a la agencia de cualquier tipo de efecto adverso que les llegue y la FDA también presta atención directamente a pacientes y médicos en este ámbito.
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