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Trial patients OD after clinic failed to weigh them

By Nick Taylor, 14-Jan-2009

Related topics: Phase I-II, Regulatory affairs, Clinical Development, Patient safety

 

A FDA warning letter has been sent to a clinical investigator who administered incorrect doses of investigational drugs having taken the patient’s weight and height from their driving license.

 

The US Food and Drug Administration (FDA) letter was sent to Dr Nicola Spirtos who conducted a Phase II trial of a combination therapy at the Woman’s Cancer Center of Nevada in Las Vegas, US. It is not clear from the letter what drug was being trialed or which company was developing it.

Spirtos’ patient weighed less than the weight given on their driving license and consequently they were overdosed with investigational drugs on five occasions, according to the FDA.

The warning letter states that this was compounded as the clinic did not recalculate the dosage after the patient’s weight decreased by 10 per cent between the baseline visit and the fifth cycle.

Another patient was also administered with excessive doses of investigational drugs on six occasions after the clinic took their weight from their driving license.

Further mistakes are cited in the warning letter, including the accusation that, on one occasion, the clinic administered the investigational drugs in the wrong order.

The warning letter also claims that the clinic failed to decrease a patient’s dose for the fourth treatment cycle in response to the Grade 4 neutropenia that was identified a week earlier.

A copy of the complete letter can be found here .

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