FDA 2009 Report (cont’d)

2) Lilly sales representatives and marketing materials do not

adequately inform physicians about the likelihood and severity

of Cymbalta discontinuation syndrome

• Unaware physicians unable to discuss Cymbalta benefit-risk profile (including

discontinuation) with their patients

– Physicians can not make an accurate comparative assessment of Cymbalta vs. alternatives

– Patients can not make an fully informed choice to take the drug

• Practical effects (common in anecdotal reports):

– Patient becomes totally distrustful of the physician who did not advise/warn them in the

first place

• Doctor /patient relationship is wrecked

• Patient in distress refuses to ingest Cymbalta under any pretext

• Tapering is taken off the table

– Patient fires the doctor or the doctor disengages from the patient

• Syndrome mood swings militate anger directed at the physician

• Physician may deny syndrome even exists

• Physician may jettison a newly “difficult” patient

– Physician seeks to avoid malpractice implications

– Patient becomes deeply suspicious of any psychotropic medication

• Underlying problem may go untreated

• This is a process flaw – there is no excuse for it

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