Teva Cleared in Deaths of Four French Patients Taking Its Drug

Teva pulled suspicious batches of medicine off shelves two weeks ago.

The Teva drug taken by elderly French people who died recently was not the cause of their deaths, concluded the head of France's drug oversight agency. The announcement by Dominique Maraninchi, chairman of the French National Agency for the Safety of Medicines, comes in the wake of concerns about the cardiac insufficiency drug Furosemide, manufactured by Teva in France.

Maraninchi announced on Europe 1 television that the packages labeled as Furosemide actually contained a sleep medication, but that had not caused the deaths of the patients. He said that patients who normally take Furosemide could resume the medication.

Maraninchi said his agency had examined 70,000 Furosemide packages produced at the Teva plant in Sens, France, but had not found a single package that did not contain the proper medicine. Teva pulled the suspicious batches of medicine off pharmacy shelves two weeks ago after a French pharmacist reported that a package labeled Furosemide actually contained the sleep medication, Zopiclone, which is also produced at the Sens plant.

The pharmacist's concern was prompted by the complaint of a patient who had been prescribed Furosemide and said that he was feeling unusually sleepy. Suspicions were heightened by the death of a 92-year-old man being treated for cardiac insufficiency with Teva's Furosemide, and the subsequent deaths of three other patients who had also been prescribed the Teva drug. A team from the French drug oversight agency was then dispatched to the Sens plant under police supervision but found no evidence of negligence or faulty production practices at the plant.

Maraninchi said the 57,000 French patients who had been prescribed Teva's version of Furosemide could resume taking the drug. When asked in an interview how many victims there had been in the still unexplained affair, Maraninchi declined to speak of "victims." The average age of patients taking Furosemide, he noted, is 75 and a quarter of the patients are 85. Although patients may have died while on the drug, there was no evidence that the Teva drug had caused their deaths, he said.

Teva's Viagra gets green light in Europe

In other news related to Teva's European operations, the company has begun selling a generic version of Viagra, the impotency drug, in a number of European countries including Britain after the European patent on Viagra expired yesterday. Teva is expected to face significant competition in its sale of the generic drug from 19 other generic manufacturers. Teva is currently barred from selling the product in the United States, where the patent on Viagra does not expire until 2020. Canadian sales of the generic Teva drug are already underway after Teva won a patent infringement suit filed by Pfizer there that went all the way to the Canadian Supreme Court.

Over the weekend, Teva also received approval from the U.S. Food and Drug Administration, after protracted litigation, to sell an over-the-counter morning-after contraceptive Plan B One Step to female patients of "child-bearing age potential" without restrictions as to age.

AFP