Client Alert: 2012 OPDP Warning and Untitled Letters

2222012 OPDP Warning and Untitled Letters
Date with
Hyperlink
to Letter
Drug and Indications Referenced
in Letter
Boxed
Warning
Form of
Communication
Summary of Alleged Violations
08-01-2012 Daliresp®
For treatment to reduce the risk of
Chronic Obstructive Pulmonary
Disease (COPD) exacerbations in
patients with severe COPD
associated with chronic bronchitis
and a history of exacerbations.
No Oral Statements † Broadening of Indication:
o Sales representatives stated in a sales call to a physician’s office that
Daliresp was effective for COPD exacerbations without presenting the
appropriate patient population for the drug. Nor did the representatives
state the limitations of use that Daliresp is not a bronchodilator and is not
indicated for the relief of acute bronchospasms.
Minimization of Risk:
o Sales representatives responded to direct questions regarding the risks of
weight loss and psychiatric events including suicidality in a manner
consistent with the PI, but immediately downplayed the risks with
anecdotal claims regarding other physicians’ experience with the drug and
their lack of reports on any adverse events.
o Sales representative minimized the risk of weight loss by saying it may
actually be beneficial in overweight COPD patients.
08-10-2012 Amyvid®
For Positron Emission
Tomography (PET) imaging of the
brain to estimate β-amyloid
neuritic plaque density in adult
patients with cognitive impairment
who are being evaluated for
Alzheimer’s Disease (AD) and
other causes of cognitive decline.
No
Webpage,
Commercial
Exhibit Image
Misleading Presentation:
o Image presentation suggests that Amyvid PET images can be displayed
and therefore interpreted in color in patients, but the PI states that images
should be displayed and reviewed using a black-white scale.
o The PI does not provide instructions for estimating β-amyloid neuritic
plaque density using a color scale with Amylid, so use of a color PET scan
image is misleading, particularly considering a warning regarding the risk
of image misinterpretation and other errors.
09-18-2012* FazaClo®
For the management of severely ill
schizophrenic patients who fail to
respond adequately to standard
drug treatment for schizophrenia;
for reducing the risk of recurrent
suicidal behavior in patients with
schizophrenia or schizoaffective
disorder who are judged to be at
chronic risk for re-experiencing
suicidal behavior, based on history
and recent clinical state.
Yes
Direct-to-
Consumer Patient
Brochure
16
Omission/Minimization of Risk Information:
o Brochure fails to state that agranulocytosis is a potentially life-threatening
adverse reaction and that patients must have a baseline white blood cell
count and absolute neutrophil count before initiation of treatment, as well
as weekly for 4 weeks following drug discontinuation.
o Brochure fails to state that only after acceptable white blood cell counts
and absolute neutrophil counts have been maintained during the first 6
months of treatment can a patient be monitored every 2 weeks for the next
6 months.
o Statement advises patients to see the enclosed PI and Boxed Warning, but
fails to include material facts about significant risks, such as the fact that
elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk for death and that FazaClo is not approved