The US Food and Drug Administration is warning that the antipsychotic drug ziprasidone (marketed under the brand name Geodon by pharma giant Pfizer, and its gen Pfizer received a warning letter from the U.S. Food and Drug Administration (FDA) last week, citing the pharmaceutical giant for inadequate clinical trial monitoring in the study of a pediatric drug—violations that led to the overdosing of at least 26 children. The US FDA is requiring Pfizer to slap yet another warning label on its antipsychotic Geodon (ziprasidone). The agency warned patients that the off-patent drug has been associated with a potentially fatal condition called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), which can cause fever, rash, and swelling of lymph glands, liver, kidney, lungs, heart, or pancreas. The FDA issued a black box warning for Geodon side effects in 2005 due to risks of giving the medication to elderly patients with dementia. It had also been linked to with the conditions Tardive Dyskinesia and Neuroleptic Malignant Syndrome. The U.S. Food and Drug Administration posted a warning letter earlier this month, directed at the pharmaceutical company Pfizer. It states that at least 13 children overdosed in Pfizer’s clinical trials for the antipsychotic medication Geodon. The FDA warned of significant violations in connection with Pfizer's sponsorship of clinical trials of the antipsychotic in pediatric patients. Geodon FDA Alerts The FDA Alert(s) below may be specifically about Geodon or relate to a group or class of drugs which include Geodon (ziprasidone). MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. The U.S. Food and Drug Administration (FDA) is warning that the antipsychotic drug ziprasidone (marketed under the brand name, Geodon, and its generics) is associated with a rare but serious skin. Warning Letter: A Warning Letter is an informal advisory, to a firm or clinical investigator, communicating the Agency's position on a matter but does not commit FDA to taking enforcement action. A Warning Letter is issued for significant regulatory violations that require prompt and adequate corrective actions. The FDA has published a warning letter it sent earlier this month to Martin Mackay, Pfizer’s senior vice president, global research and development, citing “significant violations” discovered during inspections of a number of clinical investigators conducting the trial.