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Was the Warning of a Severe Reaction To a Drug, Overlooked?

by Medindia Content Team on  October 14, 2006 at 7:05 PM Drug News   - G J E 4
Was the Warning of a Severe Reaction To a Drug, Overlooked?
Despite a clear indication in a scientific journal regarding a plausible adverse reaction of a drug undergoing clinical trial, the drug was tested on human participants, which turned awry triggering a severe drug reaction. But for the timely emergency care services, the participants would have been history.
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A Dutch report documenting the reasons for the mishap of the trial, blamed gross negligence to clear warnings of a lurking severe reaction, which had certainly gone unheeded. An antibody drug, called TGN1412, caused the participants to suffer an immune reaction. The participants carry an enhanced risk of suffering cancer or arthritis during their lifetime.

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Prior trials on rhesus monkeys were successful which prompted the first stage of the human trial at Northwick Park Hospital in London. TNG1412 was the brain child of a relatively small biotech company, Genero Immuno Therapeutics , for the treatment of B cell chronic lymphocytic leukaemia and rheumatoid arthritis.



Source: Medindia
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