FDA won't relabel Lilly's schizophrenia injectable after patient deaths
- Although two patients died in 2013 several days after receiving Zyprexa(olanzapine) injection, the FDA's investigation into the deaths was inconclusive.
- Zyprexa comes with a black box warning for post-injection delirium sedation or olanzapine overdose.
- In 2011, Zyprexa started losing patent protection in different markets, leading to reduced sales. Between 2011 and 2014, sales fell from $4.62 billion to $1.04 billion.
The FDA's investigation into the Zprexa Relprevv deaths was initially reported on in June 2013, and subsequently updated on March 23. The investigators determined that there was a possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular (IM) injection. Also, much of the drug level increase could have occurred after death, a finding which is consistent with extremely high blood levels of drug several days after a patient receives the Zyprexa Relprevv injection.
While the FDA is not requiring Eli Lilly to update labeling as a result of these deaths, there are strict protocols in place around this injectable drug. Everyone involved in any aspect of administering the Zyprexa Relprevv injections, from the pharmacy, to the healthcare institution, to the healthcare practitioner must complete the Zyprexa Relprevv Patient Care Program. And after the patient receives the injection, he or she must be accompanied to their destination. All told, this is a balanced response this unfortunate occurrence.