U.S. health regulators have warned Pfizer Inc over a series of failures that led to the overdosing of at least 13 children in a clinical trial of its antipsychotic drug Geodon, according to a letter made public on Tuesday.
The FDA, in an April 9 warning letter to the world's largest drugmaker, said Pfizer "failed to ensure proper monitoring" of the trial in which several children given overdoses experienced tremors, restless legs and other complications.