FDA Issues Warning on High Doses of Schizophrenia Drug
> 9/18/2007 9:16:47 AM

Yesterday, the Food and Drug Administration released information regarding warnings to be added to the label of the drug haloperidol, marketed by Johnson & Johnson as Haldol. The drug, which was originally created by Janssen in the 1950's, is commonly used in the treatment of schizophrenia as well as acute psychotic disorder and delirium. Since it's approval, haloperidol has become an effective tool for emergency responders and medical professionals who treat individuals in the grips of severe, and sometimes dangerous, psychotic episodes. As a neuroleptic, haloperidol has proven successful in helping those whose schizophrenia has resisted treatment or those who have had difficulty maintaining their medication regimen.

The new warnings about the drug relate to the potential for strong negative side effects, particularly when the drug is given in high doses or administered intravenously, an off-label practice. Specifically, the warnings state that QT prolongation and Torsades de Pointes, both serious cardiac conditions, have been observed in individuals who receive high doses of haloperidol. The FDA has approved intramuscular injections of the drug, but there is evidence that intravenous injections occur with some frequency, and these off-label administrations of the drug have the strongest potential for negative outcomes.

These new warnings are very important for anyone who uses haloperidol or prescribes it. Both QT prolongation and Torsades de Pointes can result in death. Data shows that there is a strong relationship between dosage and consequent negative outcomes, which is why intravenous administration has caused so many problems. Those who adhere to standard recommendations for haloperidol usage most likely need not be concerned about these new warnings, but as with any new information, it is best to consult your prescribing physician. Haloperidol may cause problems in high doses, but it remains a treatment that helps many deal with otherwise crippling psychosis.

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