Haloperidol decanoate usp monograph

In a related issue, Risperdal sales practices resulted in a 2012 provisional settlement totaling $ billion. [17] The United States Department of Justice began investigating Risperdal sales practices in 2004, and in 2010 joined a whistleblowers suit alleging bribes paid to Omnicare , the largest company supplying pharmaceutical drugs to nursing homes. [18] [19] The allegations include that Johnson & Johnson and Janssen were warned by the . Food and Drug Administration (FDA) not to promote Risperdal as effective and safe for elderly patients when in fact it is associated with early death, but they did so; and that they in fact bribed Omnicare pharmacists tens of millions of dollars to promote the drug to care home physicians for this unapproved use. A settlement was provisionally agreed with Johnson & Johnson of around $ billion for this and related allegations, with Omnicare having already settled for around $100 million. [17] Former head of sales and president of Janssen, Alex Gorsky , who the Dept of Justice say “was actively involved” in the fraud, nevertheless become the new CEO of Johnson & Johnson in 2012. [20]

There are no well controlled studies with Haloperidol injection in pregnant women. There are reports, however, of cases of limb malformations observed following maternal use of Haloperidol 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 Haloperidol, 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.

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Haloperidol decanoate usp monograph

haloperidol decanoate usp monograph

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