Lorcaserin Side Effects

From Pharmacy Drug Guide

Lorcaserin is an investigational drug being developed as an appetite suppressant. Lorcaserin works by affecting serotonin, a key neurotransmitter in the brain, helping to eliminate hunger. Despite promising early trials, lorcaserin was rejected by the FDA in October, 2010. The FDA cited concerns about animal testing results.^{[1] [2]} The initial clinical trials also found significant neurological, psychiatric and cognitive side effects. Early clinical trials also found that weight loss in subjects given lorcaserin was only about 3% greater than in those given a placebo, which the FDA considered "marginal."^{[3] [4]}

Arena Pharmaceuticals resubmitted lorcaserin to the FDA for approval in 2011 after addressing these concerns. In May 2012, a panel of experts recommended to the FDA that lorcaserin be approved. The FDA is not required to follow these recommendations, but often does.^{[5] [6]}

Contents 1 Common Lorcaserin Side Effects 2 About Drug Side Effects 3 Lorcaserin Precautions and Warnings 4 References

Common Lorcaserin Side Effects

In trials, lorcaserin was considered generally very well tolerated. The most common reported side effects or "adverse events" were headaches, upper respiratory tract infections, sinusitis, nausea, dry mouth, fatigue, dizziness, vomiting and urinary tract infections.^[5] The same trials found neurological, psychiatric and cognitive side effects. These included perceptual or dissociative reactions, dizziness, fatigue, anxiety, depression, and abnormal dreams. ^[4]

Side effects reported in animal testing which contributed to the FDA's decision to initially reject lorcaserin include mammary tumors and possible heart valve problems found in rats.^{[1] [2]}

About Drug Side Effects

Lorcaserin Precautions and Warnings

To date, the FDA has not approved Lorcaserin due to concerns about the potential of more severe side effects. The manufacturer is engaged in ongoing trials to certify the drug's safety. The FDA has cited concerns about events of depression, anxiety and suicidal ideation. The agency has also cited concerns about mammary tumors that occurred in laboratory rats during trials, as well as the possibility of heart valve irregularities.^[4]

Also See: Lorcaserin Approval, Contrave Approval, Contrave Side Effects, Alli, Qnexa Approval. Qnexa Side Effects, Adipex Side Effects, Xenical Side Effects.

References

1. ↑ ^{1.0 1.1} https://www.nytimes.com/2010/10/24/business/24obesity.html
2. ↑ ^{2.0 2.1} http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2010/09/15/BU521FDLBC.DTL
3. ↑ http://www.prnewswire.com/news-releases/fda-issues-complete-response-letter-for-lorcaserin-new-drug-application-105586113.html
4. ↑ ^{4.0 4.1 4.2} http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM225631.pdf
5. ↑ ^{5.0 5.1} http://www.lorcaserindietpill.com/
6. ↑ http://www.cbsnews.com/8301-504763_162-57432777-10391704/panel-advises-fda-to-approve-lorcaserin-obesity-pill/