Pfizer failed to update dosing guidelines in a clinical study of its bipolar disorder drug Geodon, according to a warning letter from the Food and Drug Administration. The lack of oversight led to 26 overdoses in 2006, when Pfizer first learned about the problem, and three more in 2007.
Geodon is approved as a treatment for schizophrenia and bipolar disorder in adults and is being tested as a treatment for bipolar disorder in children.
The drugmaker says it first notified the FDA about the problem in 2006 and has been updating its guidelines ever since. However, an FDA investigation in 2009 found that the study’s problems had not been fixed.
Read more in the Associated Press.


