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On April 9, 2008, the FDA announced new safety
risks perhaps associated with Pfizer’s diabetes drug, Exubera.  Exubera is an inhaled insulin product that
was approved for use in the United
States
in 2006.  Recent clinical trials have exposed a concern
that Exubera may be causing primary lung cancer.  The study uncovered six new cases of lung
cancer versus only one case in the control subjects who were taking a placebo.  Pfizer has also noted that it has received at
least one report of lung cancer in patients using the drug.  Pfizer’s correspondence to physicians
indicates that there “were too few cases to determine whether the emergence of
these events is related to Exubera.  All
patients who were diagnosed with lung cancer had a prior history of cigarette
smoking.”  Pfizer further assured
patients “Exubera remains a safe and effective medication.” 

The labeling for Exubera notes
that the drug should not be prescribed to current smokers, smokers who recently
quit smoking, and patients with certain lung diseases (including chronic
obstructive pulmonary disease, emphysema, and asthma).  Patients with these conditions are at
particular risk since these conditions can impact the manner in which the
inhaled drug is absorbed by patient’s bodies through their lung tissue. 

 

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