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
(MS).
Boxed
Warning
Form of
Communication
Summary of Alleged Violations
able to walk longer distances with decreased use of assistive devices, but
clinical studies do not indicate whether the observed change in walking
speed in patients supports this claim.
o Claims and images suggest that treatment can have a positive impact on the
disability caused by MS such that patients can carry out daily activities that
they may have stopped due to difficulty walking, but poll results do not
constitute substantial evidence supporting this claim.
Minimization of Risk Information:
o Video minimizes the risks of Ampyra by failing to convey significant risk
information during the patient interview and presenting the majority of risk
information to a running telescript format with rapidly scrolling, small text.
o Video statement implies that patients who experience adverse events such
as paresthesia and insomnia “will get used to it” and such events will
disappear within a month, but FDA is not aware of substantial evidence or
experience supporting this claim.
06-25-2012 Equetro®
For treatment of acute manic and
mixed episodes associated with
Bipolar I Disorder.
Yes
Professional
Webpages
Omission/Minimization of Risk Information:
o Webpages entirely omit all risk information from the Contraindications and
Precautions section of the PI, as well as certain warning information.
o Statement referring readers to the full PI does not mitigate the omission of
important risk information.
o Webpages fail to include important material facts regarding the increased
risk of suicidal behaviors and ideation associated with use of the drug.
o Webpages misleadingly claim that anti-epileptic drugs “may increase” the
risk of suicidal thoughts or behaviors when the PI indicates that a direct
relationship between such drugs and suicidal behavior and ideation has
been determined.
Unsubstantiated Claims:
o Claims suggest that patients treated with Equetro will experience no weight
gain when this has not been demonstrated and data from pivotal trials
clearly demonstrate a weight increase in patients during Equetro treatment.
o Webpage presents an open-label extension study in support of no weight
gain claims, but safety data derived from the study do not constitute
substantial evidence and there was a significant drop-out rate in the study.
o Claims and presentations suggest that patients with Bipolar I Disorder
treated with Equetro experience no worsening of depression or depression
symptoms when this has not been demonstrated. The cited study is not
substantial evidence because the depression score used in the study was not
a pre-specified measure and the study itself calls for larger controlled
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