Historical Archive

Zanni (Sanofi Italia), 2013 marked a change of pace

A sleeping pill contained in a diuretic.
After the 90-year-old died on Friday 7 June in Marseilles, in the South of France, the probable erroneous canning of Furosemide by the Teva laboratory is suspected of being the cause of a new death in France, and hospitalization.
While the results of the autopsy on the elderly man who died in Marseille are still awaited, the suspicious death of a centenarian, who died a few weeks ago in Compiegne, in the North, is also being examined by the doctors.
PRODUCT WITHDRAWN AS A PRECAUTION. Furthermore, another elderly person is said to be in serious condition in hospital in Tours, in the Centre, after having swallowed a sleeping pill.
For this reason, all batches of the diuretic Furosemide 40 mg from the pharmaceutical laboratory Teva have been subject to a recall order in France for "precautionary measure". This was announced by the drug agency (Ansm). The decision was taken to "avoid any confusion" after the withdrawal of two batches of the diuretic on Friday 7 June.
REPORT OF THE CODACONS. For this reason, Codacons has decided to file a complaint with the Rome Public Prosecutor's Office: "The news is alarming as well as tragic", explained the consumers' association, "because Teva, during the procedure for packaging diuretic tablets, would have replaced this drug with sleeping pills produced in the same laboratory. Although the company claims to have withdrawn the lots in question, the silence maintained on the matter is extremely serious, and the total absence of certain information relating to the situation in Italy. Citizens, on the other hand, have been left in total misinformation and uncertainty and the initiatives undertaken to protect health by the Ministry and AIFA are not known.
The association has therefore asked the judiciary to open a special investigation and, should the error also concern our country, it has made itself available to the citizens who purchase the drug for any compensation actions.
But it was the company itself that reassured Italian users. Teva has made it known that the formulation of Furosemide Teva 40 mg (Lasix specialty) "is not present in Italy".
TEVA: «NOT SOLD IN ITALY». Already on June 9, Teva announced that it had communicated the situation to the Italian authorities and that the canning error was confined to France.
AIFA: «NO ALARM». And on the matter, also reported the Italian Medicines Agency, which specified that the batches of diuretics "are not marketed in Italy". And he then added: «With regard to the affair relating to the exchange of drugs that took place in France (zopiclone sedative inside a pack of the diuretic furosemide)», AIFA underlined in a note, «the Italian Medicines Agency announces that it promptly took action in this regard and received a note from the Ansm, the French regulatory agency, which clarified that the lots Y175 and Y176, for which the French authorities ordered their withdrawal from the market, were not marketed in Italy ».
Therefore, Aifa assured, "there is no reason for alarm for Italian citizens". However, the Agency, through the European pharmacovigilance network, continues to monitor developments in the situation in real time.

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco