No evidence of fault at Teva plant linked to drug switch death
pharmafile | June 14, 2013 | News story | Manufacturing and Production | Teva, death
France’s medicines regulator has concluded that a plant operated in the country by generic drugmaker Teva was not at fault in the case of drug switching that may have been linked to a patient death.
The ANSM (Agence Nationale de Sécurité de Médicament et des Produits de Santé) inspected the facility in Sens, Burgundy, on Monday in the wake of the death of a 91-year-old man who had been taking a generic furosemide product that turned out to have been substituted with a sleeping pill (zopiclone).
The preliminary inspection did not identify any major problems with the “organisation, practices or equipment used at the site”, according to the ANSM, which has been systematically checking different batches of the 40mg furosemide product, which is used to treat heart failure.
The check, which was carried out under supervision by a bailiff, will however continue over the coming days and eventually look at several thousand boxes to “identify the extent of the non-compliance”, said the agency.
The company said it welcomed the findings of the ANSM inspection and “continues to conduct its internal investigation and to open and inspect blisters of furosemide” and will complete its review “as soon as possible”.
As a precaution, a recall of Teva 40mg furosemide – initially confined to two lots – has now been expanded to include all the inventory of the product on the market.
The finding raises the possibility that the switch resulted from malicious tampering, according to Teva France chief executive Erick Roche.
The generic drugmaker maintains the two drugs were made at different times and would have been on the production line ‘several weeks apart’, with furosemide tablets manufactured in Hungary and zopiclone made in Spain, so human intervention is now the prime suspect in the case.
Meanwhile, another five deaths among patients taking the furosemide product are also being investigated, according to a report in French newspaper Le Monde, although at present no other pack has been found with the drug switch.
Investigators are still waiting for the results of toxicology to tests to establish whether those who died had been exposed to zopiclone.
Phil Taylor
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