Posts Tagged ‘drug safety’

A Revealing FDA Op-Ed About Lorcaserin and Obesity

September 10, 2020 — Back in February we complained about “a near complete failure of transparency in drug safety decision making” by FDA. Our complaint had to do with taking lorcaserin (Belviq) off the market. Today, FDA took a step toward a bit more transparency. In the New England Journal of Medicine, senior FDA officials explained their thinking about […]

Landmark Cardiovascular Outcomes Study for Belviq

July 18, 2018 — For the first time ever, we have direct evidence for the long-term cardiovascular safety of an obesity medication. The drug is Belviq, also known as lorcaserin. Yesterday, Eisai released topline results for the long-awaited CAMILLIA-TIMI 61 trial. This was a five-year cardiovascular outcomes study of 12,000 patients. It was randomized and placebo controlled. CV Safety […]

Divided FDA Advisory Committee Votes to Require Cardiovascular Testing for New Obesity Drugs

March 29, 2012 — March 29, 21012 — A panel of experts at the FDA voted 17-6 in favor of requiring all new obesity drugs seeking approval to provide phase 2 or 3 safety data ruling out excess cardiovascular risk, even if the drug does not appear to have a cardiovascular profile.