FDA Announces Lilly’s Zyprexa Investigation after Two Deaths

On June 18, 2013, the Federal Drug Administration (FDA) announced it is investigating the deaths of two patients given intramuscular (IM) injections of the antipsychotic drug Zyprexa Relprevv (olanzapine pamoate) within three to four days of receiving the injected dose. Patients should be monitored for a minimum of three hours after receiving the IM-injectable form of the olanzapine pamoate as per the Lilly Risk Evaluation and Mitigation Strategy (REMS). Post-mortem evaluation showed both patients had high olanzapine pamoate blood concentration levels. The deaths are not considered overdose incidents as both received the proper dosage.

Zyprexa is a treatment for depression, schizophrenia, aggression, bipolar illness, and manic disorders. Patients must receive Zyprexa Relprevv injections at a certified medical facility, then receive monitoring for three hours or more after dosing. Zyprexa Relprevv labeling contains severe warnings about possible risks of post-injection delirium sedation syndrome (PDSS). This medical complication occurs when the drug enters the bloodstream too rapidly after an IM injection. PDSS may cause cardiac arrhythmia/arrest, delirium, coma, or a sedation state.

A Lilly spokesperson said the company was unable to determine if the two deaths are related to the use of Zyprex Relprevv.

According to author Robert Whitaker, (Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs and the Astonishing Rise of Mental Illness, 2010) psychiatric drugs like olanzapine pamoate are frequently prescribed for a long list of mental illnesses and conditions.

The editors of Atypical Antipsychotics (General Books, 2010) write that olanzapine formulas are frequently used to treat anxiety-type illnesses and disorders, including generalized anxiety disorder, delusional parasitosis, panic attacks/disorder, and PTSD. The drug’s “off-label” (not FDA-approved) uses include treatment for depressive disorders, eating disorders (e.g. anorexia), and Tourette’s syndrome.

Zyprexa earned $1.7 billion in revenues for Indianapolis, Indiana–based Eli Lilly in 2012. Sales of Zyprexa were $5.03 billion, according to Bloomberg, in 2010. The oral form of Zyprexa lost its patented status in 2011. Sales of the injectable form of Zyprexa, which has no generic counterpart, reached approximately $60 million in 2012.

The FDA states that any new or continued therapeutic use of Zyprexa requires careful administration and monitoring, according to the Lilly REMS requirements. Patients and their caregivers should address any questions about Zyprexa to doctors and healthcare professionals. The FDA asks doctors and healthcare providers to call the MedWatch Safety Information and Adverse Event Reporting Program immediately regarding any side effects or negative reactions to Zyprexa Relprevv.

References:

“Anatomy of an Epidemic,” Robert Whitaker. Crown Paperbacks: New York, 2010. (Chapter 4: Psychiatry’s Magic Bullets)

“Brain Disabling Treatments in Psychiatry,” Peter Roger Breggin. Springer Publishing Company: New York, 2008. (Risks Associated with Atypical Psychiatric Drugs; Chapter 5: Neuroleptic-Induced Neurotoxicity)

FDA Investigating Lilly’s Zyprexa Injection After Two Die” Drew Armstrong. Bloomberg. June 18, 2013.