The Food and Drug Administration asked Eisai to voluntarily withdraw lorcaserin weight loss medication (Belviq and Belviq XR) on February 13 after a post-marketing trial with more than 12,000 subjects that revealed a higher incidence of cancer .
In a Communication on medication safety, the agency said that "health professionals should stop prescribing and dispensing lorcaserin to patients. Contact patients currently taking lorcaserin, inform them about the highest incidence of cancer observed in the trial. and ask them to stop taking the medication. Discuss with your patients medications or alternative weight loss strategies. "
Eisai is complying with the withdrawal request.
The decision is based on the review of the 5-year trial agency, which was designed to assess the cardiac risk with the drug and ended in June 2018. In total, 7.7% of patients randomized to 10 Lorcaserin mg twice daily was diagnosed with 520 primary cancers, compared with 7.1% of placebo subjects diagnosed with 470 cancers, during a median follow-up of 3 years and 3 months. An additional cancer was observed for every 470 patients treated for 1 year.
"There were no apparent differences in the incidence of cancer during the first months of treatment, but the imbalance increased with the duration of lorcaserin," the FDA said. Pancreatic, colorectal and lung cancers were among those diagnosed.
In summary, "we believe that the risks of lorcaserin outweigh its benefits based on our complete review of" the data, the agency said. The FDA does not recommend special cancer screenings for patients who have taken lorcaserin.
The action follows an FDA alert in January about a possible high risk of cancer according to its preliminary analysis of the study.
Patients were also advised on February 13 to stop taking the medication and talk with their providers about alternative weight loss medications and weight management programs.
They were also told to discard the pills at a drug return location, if available, but if not, to mix them with an "unattractive substance" such as soil, cat litter or ground coffee; seal them in a plastic bag; and put them in the trash.
This article originally appeared on MDedge.com.
. (tagsToTranslate) us. food and medicine administration (t) food and medicine administration of the united states (t) fda (t) dietary supplements (t) weight loss (t) weight control (t) medication safety / treatment (t) regulation of medications (t) cancer (t) malignancy (t) carcinoma (t) cancer risk (t) patient safety