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Antipsychotics May Prompt Short-Term Somatic Serious Adverse Events

July 31, 2019

By David Douglas

NEW YORK—In patients with severe mental health disorders, second-generation antipsychotics may lead to short-term somatic serious adverse events on top of those occurring independently of treatment, according to pooled data from more than 300 trials.

As Drs. Johannes Schneider-Thoma and Stefan Leucht told Reuters Health by email, "We found an increased odds of somatic serious adverse events with antipsychotics compared to placebo and clinicians should be aware of this. Nevertheless, the incidence of serious adverse events under placebo was 80% of that of antipsychotics, meaning that most serious adverse events occurring in the studies were not caused by antipsychotics."

In a July 15 online paper in The Lancet Psychiatry, Drs. Schneider-Thoma and Leucht of the Technical University of Munich, Germany, and colleagues note that to establish this primary outcome they conducted a systematic review and meta-analysis of data from 314 randomized controlled trials with 67,642 participants and a median duration of 6 weeks.

At least one somatic serious adverse event occurred in 698 to 862 out of 42,600 patients on antipsychotics, and in 343 to 419 of 25,042 patients randomly assigned to placebo. The summary odds ratio (1.24) using the minimum and maximum estimates was statistically significant.

In predefined subgroup analyses, there appeared to be a greater effect in patients over the age of 65 (OR 1.56 to 1.58) than in younger adults (OR 1.09 to 1.10). The effect was also greater in pediatric patients (OR 1.49 to 1.54).

Summing up, Drs. Schneider-Thoma and Leucht conclude, "While the increased odds in general adults (18-65 years) was small and uncertain, it was more pronounced in elderly patients, and possibly children and adolescents for whom, however, few data were available. In the latter groups clinicians should be particularly careful."

In an editorial, Dr. Takefumi Suzuki of the University of Yamanash, Japan, notes, "Lumping second generation antipsychotics together as a single entity, as was done for the main analysis... can be problematic."

He also notes that "older people are more vulnerable to adverse events from all kinds of medications, including antipsychotics, and this is also true for younger populations."

But notwithstanding these and other limitations, he concludes that "the results of this crucial work should be prudently translated to guide real-world clinical practice."


Lancet Psychiatry 2019.

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