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US asks Genentech to put black box warnings for Raptiva 10-18-08
The U.S has ordered Genentech Inc to add on the labeling black-box warnings
for its psoriasis drug called Raptiva because there have been reports of
life-threatening infections associated with use of this drug.
The Food and Drug Administration said Thursday the warnings will alert doctors
and patients to the possible risk of progressive multifocal leukoencephalopathy
(PML) and other serious infections.
Raptiva is approved to treat moderate to severe forms of the scaly skin in
adults, but this drug can by itself raise risk of bacterial sepsis, viral
meningitis and invasive fungal disease, the FDA says in a statement.
"Doctors and other prescribers should carefully evaluate and weigh the
risk/benefit profile of Raptiva for patients who would be more susceptible to
these risks," said Janet Woodcock, head of the FDA's Center for Drug Evaluation
and Research.
The FDA requested the warnings because it had received reports of cases in which
patients on Raptiva were hospitalized and some died.
Genentech said it only knew one death case involving a 70-year-old who had used
Raptiva for more than 4 years, Reuters reported. But the company said it would
add the warnings to the drug's packaging immediately and send a letter to
doctors to alert them to the labeling change.
Drug makers are not responsible for any deaths associated with use of any drug
that has been approved by the FDA unless any problem with the ingredients or
processing for the drug causes the death, which is almost impossibly to occur.