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), manufactured by Eli Lilly & Co.
The patients died 3-4 days after they received an “appropriate dose” of the drug, long 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 levels of the drug in their systems, which can cause delirium, cardiac arrest and arrhythmias, as well as coma or loss of consciousness, as reported by the FDA.
Under the REMS, patients are required to receive the Zyprexa Relprevv injection at a REMS-certified health care facility, and to be continuously monitored at the facility for at least 3 hours following an injection, and to be accompanied home from the facility. These steps are in response to concerns about post-injection delirium sedation syndrome, a serious condition in which the drug enters the blood too fast, leading to elevated blood levels and marked sedation, which can include coma and/or delirium. This post-injection warning is contained in the Zyprexa Relprevv label.
Administration of the drug is tightly controlled. Doctors, patients and health care facilities must be approved prior to being allowed to use this drug.
The FDA has provided 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.
Zyprexa generated $1.7 billion in revenue for Lilly last year, and sales peaked in 2010 at $5.03 billion, according to data compiled by Bloomberg. Zyprexa Relprevv sold less than $60 million in 2012, according to Morry Smulevitz, a spokesman for Indianapolis-based Lilly.
Patients and caregivers should consult with their health care professionals about any questions or concerns they may have.
For more information, feel free to contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).
