DCGI, others told to remove monographs of lorcaserin hydrochloride hemihydrate, lorcaserin tablets from Indian Pharmacopoeia

According to the notice, Lorcaserin has been voluntarily removed from the US market based on the outcome of a safety clinical trial and the potential risk of cancer associated with the drug.

Medical Dialogues team had earlier reported that the US Food and Drug Administration (USFDA) had requested the manufacturer of Belviq (Lorcaserin) to voluntarily withdraw the weight-loss drug from the U.S market. The warning was issued after a safety clinical trial showed an increased occurrence of cancer associated with the use of lorcaserin. This was based on the findings from ( CAMELLIA-TIMI 61) clinical trial – randomized, double-blind, placebo-controlled, multicenter, parallel-group trial conducted between January 2014 and June 2018 in the US, Canada, Mexico, The Bahamas, Europe, South America, Australia, and New Zealand.

In light of the above, monographs of 'Lorcaserin Hydrochloride Hemihydrate' and 'Lorcaserin Tablets' are omitted from the Indian Pharmacopoeia (IP) 2018. Further, the Commission has urged all stakeholders in the country to bring the matter to the attention of all authorities that they comply with it.

Also Read: Weight-Loss drug lorcaserin withdrawn from the market after FDA warning of cancer risk