In safety review documents posted to the FDA website, agency staff recommended that Eli Lilly’s antipsychotic Zyprexa (olanzapine) and Novartis’ antifungal medication Lamisil (terbinafine) should be monitored for potential risks of adverse events in the paediatric population.

Regarding Zyprexa, the agency staff noted that “no new safety signals emerged as part of this review; however, it has made us aware that the paediatric population is not spared from the adverse events caused by olanzapine therapy.” The reviewers recommended revising the product’s prescribing information to include the potential risk of metabolic effects that have been observed in both adults and children taking the drug. Zyprexa is currently approved for patients aged 18 years and older, and its labelling already includes clinical data on weight gain in younger patients taking the compound.

The staff also recommended the further investigation of psychiatric events reported among patients treated with Lamisil, including depression, suicidal ideation and self-harm. Experts on the FDA’s paediatric advisory committee are expected to discuss the safety reports and make recommendations on November 18.

Source: FirstWord

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