French Police Probing Mystery Deaths Allegedly Tied to Mislabeled Teva Drug

Evidence of negligence has yet to be found at the Teva plant, regulatory body says.

French police in mid-June expanded their investigation into the deaths of up to six patients who had taken a medication purporting to be a diuretic produced by Teva Phamaceuticals in France but that may have been a sleeping pill.

The French National Medicine Security Agency this week found no evidence of any mishandling or negligence at the Teva plant where the drug is packaged.

Furosemide, a diuretic, and zopicione, a sedative, are both produced and packaged at the Teva plant in Sens, southeast of Paris.

Israel’s Teva is the world’s largest producer of generic drugs.

A spokeswoman for the Paris prosecutor’s office told the Bloomberg news agency that six patients had died under circumstances linked to the case. The patients appear to have taken medicine labeled as furosemide, which is used to treat cardiac insufficiency, but which actually contained the sedative zopicione.

On Thursday the French newspaper Ouest France reported that counterfeit packages of the drug from India were seized last month at a warehouse in Quimper − located in Brittany, in the northwest of the country. Additional counterfeit packages purporting to contain the drug were confiscated elsewhere in France after arriving in the country via Charles de Gaulle airport in Paris, the newspaper reported.

Among the deaths was a 78-year-old man from southeastern France who had been suffering from fluid in the lungs. According to a report by the French newspaper Le Parisien, the man died after apparently taking a medicine labeled as a Teva’s furosemide but that may have actually been the sedative.

On June 8 a 92-year-old man also died after taking a drug packaged as Teva’s diuretic. The man’s death came two days after the French pharmaceutical watchdog asked pharmacies to remove 190,000 boxes of product labeled as Teva’s furosemide from the shelves.

A Teva spokesman said at the time that the death was a local incident limited to France and that the company was conducting its own inquiry. Teva later stressed that the results of the drug agency investigation had found no evidence of wrongdoing at the Teva plant.

The drug security agency has asked patients who bought identified batches of the drug to return them to their pharmacies.

According to the agency, zopicione causes drowsiness and sleep that can last one or two days for elderly patients. It cited a risk of coma for patients already taking sedatives.

AFP