The U. S. Food and Drug Adminstration stated today that it is concerned about excessive sedation following injections of Eli Lilly's long-acting form of its schizophrenia drug Zyprexa.
While the drug was found to be effective for acute and long-term treatment of schizophrenia the agency has asked an advisory panel to determine whether it finds the drug effective and "acceptably safe."
"
Excessive sedation events are a serious safety concern because of the severity of excessive sedation, the unpredictable characteristics, and relatively high incidence," said FDA staff. Meanwhile Lilly stated that the drug formulation's benefits outweighed the sedation risk. Lilly said "although there are important additional safety considerations associated with the injection, they are manageable with appropriate labeling and risk-minimization activities."
The advisory panel may decide that a black box warning is appropriate or that Zyprexa Adhera be prescribed only as a second-choice drug.
Lilly was already required to include stronger warnings on the Zyprexa label in October for hyperlipidemia, weight gain and hyperglycemia.
[Source: Reuters]
Comment Preview