Product Safety - schizophrenia
Situation:
-
Our client was faced with a potential label change based upon published evidence demonstrating an increased risk for new-onset diabetes associated with use of certain atypical anti-psychotics.
-
Previous evidence was based on variable methodological approaches and was inconclusive regarding the issue of product specific effect versus broad class effect.
IMS HEOR Approach:
-
The PharMetrics Patient-Centric Database (link to database) identified more than 2,000 patients with an average follow-up of 15 months, eligible for inclusion in a retrospective analysis of outcomes with atypical versus conventional anti-psychotics.
-
Both nested case-control and retrospective cohort techniques were employed to analyze the data for the outcome new-onset diabetes, and according to anti-psychotic class and/or specific product administered.
Outcome:
-
Results confirmed moderately increased risk of diabetes associated with all atypical anti-psychotics versus conventional forms.
-
After submission of evidence to FDA, all atypical anti-psychotic agents were required to warn of this risk, thus assuring patient safety whilst ensuring the availability of our client's product on equal terms with other class members.