Lorcaserin - Side Effects

Side Effects

Generally, lorcaserin was shown in phase III testing to be a mild and tolerable agent. Trial participants found lorcaserin about as tolerable as placebo, with 7% of participants in both the lorcaserin drug and placebo arms dropping out due to side effects. Lorcaserin had the lowest discontinuation rates due to adverse events of any obesity drug in a phase III trial, as compared to discontinuation rates due to adverse events for bupropion/naltrexone (26% vs 13% for placebo), phentermine/topiramate (18% vs 9% for placebo), orlistat (7% vs 4% for placebo), sibutramine (9% vs 9%) and rimonabant (15% vs 7%).

Lorcaserin produced side effects in human clinical trials, but at rates not significantly different than placebo and mostly with mild and transient severity. The most common side effect was headache, experienced by about 18% of drug arm participants compared to 11% of placebo participants. Headache was the only reported side effect to occur at a frequency greater than 5 percentage points above placebo. Other reported side effects and their rates for lorcaserin and placebo patients, respectively, were as follows: upper respiratory tract infection (14.8% vs. 11.9%), nasopharyngitis (13.4% vs. 12.0%), sinusitis (7.2% vs. 8.2%) and nausea (7.5% vs. 5.4%). Adverse events of depression, anxiety and suicidal ideation were infrequent and were reported at a similar rate in each treatment group.

On 15 September 2010 it was reported by national news-media that lorcaserin was associated with the development of cancer in laboratory rats.

In December 2012, the US Drug Enforcement Administration proposed classifying lorcaserin as a Schedule IV drug because it has hallucinogenic properties and users could develop psychiatric dependencies on the drug.

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