Haldol decanoate manufacturer

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There are no well controlled studies with Haldol (haloperidol) in pregnant women. There are reports, however, of cases of limb malformations observed following maternal use of Haldol along with other drugs which have suspected teratogenic potential during the first trimester of pregnancy. Causal relationships were not established in these cases. Since such experience does not exclude the possibility of fetal damage due to Haldol, this drug should be used during pregnancy or in women likely to become pregnant only if the benefit clearly justifies a potential risk to the fetus.

At the request of the Pharmacovigilance Department of the Italian Drug Agency (AIFA), the sponsor (Johnson & Johnson) performed two post-marketing analyses of QT interval prolongation and TdP with haloperidol administration (oral or injectable).  In one analysis, the sponsor searched their Benefit Risk Management worldwide safety database for QT prolongation -related adverse event reports received through June 30, 2005.  This search identified 229 reports, many of which the sponsor described as confounded by concomitant QT-prolonging drugs or medical conditions.  The reports included 73 cases of TdP, eleven of which were fatal.  Eight of the eleven fatal cases involved intravenous administration of various doses of haloperidol. 

Haldol decanoate manufacturer

haldol decanoate manufacturer

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