UPDATE
Lilly Drug Investigated After US and German Deaths; Teva cleared in France
The deaths occurred three to four days after a patient in the US and one in Germany – the FDA told this publication - took the drug which is past the 3-hour post-injection monitoring period required with the drug.
However, high levels of olanzapine were found in the blood of both patients and thus both the US Food and Drug Administration (FDA) and Eli Lilly are investigating whether the deaths are related and, if so, due to a manufacturing error.
Lilly spokesman Morry Smulevitz told in-Pharmatechnologist.com the drug is “manufactured at Lilly facilities located in Indianapolis, Indiana, USA, and Kinsale, Ireland, and at a contract manufacturer in Spokane, Washington.”
According to labeling information from website Dailymed, the contract manufacturing organization is Jubilant HollisterStier. Smulevitz added that all the facilities “are routinely inspected by regulatory agencies” and “subject to periodic internal quality audits” to ensure all operations performed are in compliance with current Good Manufacturing Practices (GMP).
As such, Lilly – who upon learning of the two deaths reported them to the FDA – is “unable to conclude whether the two deaths were related to administration of Zyprexa Relprevv” and is continuing its investigation.
FDA spokesman Stephen King confirmed that investigations were “still ongoing” yet could not divulge any further information – other than the geographic anomalies of patient location – “in order to preserve the integrity” of the case.
Since being published, Lilly has contacted in-Pharmatechnologist.com to clarify that contract manufacturer Jubilant HollisterStier is responsible only for the vehicle, not the active pharmaceutical content of Zyprexa Relprevv.
Teva Cleared Over French Deaths
In other news, the French National Agency for the Safety of Medicines and Health (ANSM) has cleared Teva Pharmaceuticals after several deaths in France were linked to a mix-up in packaging.
The Israel-headquartered firm was ordered to stop selling heart disease drug Furosemide when sleeping drug Zopliclone was found in its place within packets, earlier this month.
Following an investigation earlier this month, the French regulatory body asked Teva to initiate a systematic verification and, last week, 2374 boxes containing over 70,000 pills were examined.
Findings at Teva’s Sens, Burgundy plant did not, according to the ANSM statement, find “fault in the organization, practices or equipment capable of leading health authorities to stop the activity of the site.”
