FDA, şizofreni ilacıyla ilişkili iki ölümü soruşturuyor (İng)


FDA Investigating Two Deaths Linked to Schizophrenia Drug

By Amy Orciari Herman

The FDA is investigating the deaths of two patients following injection of the long-acting antipsychotic olanzapine pamoate (Zyprexa Relprevv). The deaths occurred 3 to 4 days after injection, well beyond the 3-hour monitoring period that the drug requires.

Postmortem blood tests revealed very high levels of olanzapine. The drug’s label includes a warning about post-injection delirium sedation syndrome, the FDA notes. This occurs when the drug enters the bloodstream too quickly, leading to sedation and possibly coma, as well as delirium. High doses can also lead to cardiopulmonary arrest and arrhythmias, according to the agency.

The FDA is reminding providers who prescribe olanzapine pamoate to follow its Risk Evaluation and Mitigation Strategy, which includes injection at a certified facility, at least 3 hours of monitoring following injection, and accompaniment to one’s home afterward.

FDA MedWatch safety alert (Free)