(BOSTON) -- A new study by researchers at Harvard University finds key limitations with the original trial that led to the FDA’s approval of Abilify, a medication widely used for the treatment of bipolar disorder.
Researchers say that the drug’s approval was based on a single trial that was too short to assess long-term effects, and was comprised of too few patients. They also say that other methodological flaws limit the applicability of the data to a wider population.
Despite these shortcomings, the study’s authors do not suggest that patients discontinue the treatment, as the drug may actually be helpful.
Their findings were published in PLoS Medicine.
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