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After death of a 90-year-old in France days ago due to the presence of a sleeping pill in a box of diuretics, the director of the EMA and the president Fofi intervened to give guarantees on these products. "It was a packaging issue, nothing to do with the safety of the drug."
17 JUN – “The case of the elderly man who died in France concerns wrong packaging. This is a very rare problem. It's not a question of generic or non-generic drugs, it's a global problem of mass distribution. We think that in Europe alone we are talking about 1 billion and 800 thousand packs a year: a mistake must not happen but unfortunately, humanly speaking, it can happen to anyone”. So the executive director of EMA, Guido Rasi, on the sidelines of the Pgeu symposium held this morning in Rome, commented on the case of death of a 90-year-old in France in recent weeks due to the presence of a sleeping pill in a box of Teva diuretics.
“Episodes like this have already happened, as far as my experience is concerned, about 3-4 times – continued Rasi – I remember, for example, a dramatic case of infusion drugs that came from Spain, and they were not generic products. At the time we managed to stop them in time also thanks to the efficiency of the Nas on Italian territory. Many cases are not known because they are intercepted first. It's a one in a million case." “Unfortunately it can happen, even if, of course, it shouldn't. This time thanks to the network of pharmacies - concluded the director of Ema - it was intercepted with a certain speed, given that it was an insidious symptom and not very easy to identify ".
Even the president of Fofi, Andrea Mandelli, intervened on the subject to give his reassurances to the citizens. “The panic over this case is unjustified. The generic drug is a safe product, we have the Medicines Agency which supervises so that the quality is within the parameters established by law, therefore people's approach to this product must be one of great trust”. As for then