waiver approval of intravenous Formulation because of the risk of arrhythmias.
dolasetron is a selective serotonin (5-HT3) receptor antagonist. The intravenous formulation was previously approved for the prevention and treatment of nausea and vomiting associated with cytotoxic chemotherapy including high dose cisplatin.
The manufacturer shall inform in a red-letter-hand about the risk of cardiac side effects of a dose-dependent prolongation of the QT, PR and QRS interval. The risk is for intravenous administration as unacceptable. The pharmaceutical company waived the registration and pulls the intravenous formulation of Anemet ® from the market, the oral dosage forms are the negative risk-benefit analysis, according to the pharmaceutical companies are hit.
It is recommended that any new regulations from Anemet ® iv make and to consider other available intravenous therapies for these indications into consideration.
red-handed letter to Anemet ® 100 mg iv injection (Dolasetronmesilat) from 02/10/2011
Source: Drug Safety
AkdÄ mail of 10 February 2011
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