The Food and Drug Administration
says it is investigating the unexplained deaths of two patients in the
wake of receiving intramuscular injections of the antipsychotic
medication Zyprexa
(generic name olanzapine). The patients died three to four days after
receiving appropriate doses of Zyprexa Relprevv, which is designed to
release slowly into the blood over two to four weeks and provide regular
dosing for adults with schizophrenia.
http://www.latimes.com/news/science/sciencenow/la-sci-fda-investigates-zyprexa-deaths-20130618,0,6455639.story
From the FDA:
The U.S. Food and Drug Administration (FDA) is investigating two
unexplained deaths in patients who received an intramuscular injection
of the antipsychotic drug Zyprexa Relprevv (olanzapine pamoate). The
patients died 3-4 days after receiving an appropriate dose of the drug,
well after the 3-hour post-injection monitoring period required under
the Zyprexa Relprevv Risk Evaluation and Mitigation Strategy (REMS).
Both patients were found to have very high olanzapine blood levels after
death. High doses of olanzapine can cause delirium, cardiopulmonary
arrest, cardiac arrhythmias, and reduced level of consciousness ranging
from sedation to coma.
FDA is providing this information to health
care professionals while it continues its investigation. If therapy
with Zyprexa Relprevv is started or continued in patients, health care
professionals should follow the REMS requirements and drug label
recommendations. Patients and caregivers should talk to their health
care professional(s) about any questions or concerns.
Under the
REMS, patients are required to receive the Zyprexa Relprevv injection at
a REMS-certified health care facility, to be continuously monitored at
the facility for at least 3 hours following an injection, and to be
accompanied home from the facility. The Zyprexa Relprevv label contains
warnings about the risk of post-injection delirium sedation syndrome
(PDSS), a serious condition in which the drug enters the blood too fast
following an intramuscular injection, causing greatly elevated blood
levels with marked sedation (possibly including coma) and/or delirium.
In the clinical trials supporting the approval of Zyprexa Relprevv,
cases of PDSS were observed within 3 hours after administration of
Zyprexa Relprevv, but there were no deaths due to PDSS. These two
patients died 3-4 days after receiving an appropriate dose of the drug,
and it is not clear whether they died from PDSS.
At this time, FDA is continuing to evaluate these deaths and will provide an update when more information is available.
