FDA Requests Withdrawal of Lorcaserin
February 13, 2020
The FDA requests the withdrawal of the weight-loss drug lorcaserin from the market due to potential increased risk of cancer.
The FDA has determined that the risk of cancer outweighs the benefits of lorcaserin therapy. A recent clinical trial found an increase in the risk of certain types of cancer, (pancreatic, colorectal, and lung), associated with lorcaserin use.
Recommendations for Healthcare Professionals
- Stop prescribing and dispensing lorcaserin to patients.
- Contact patients currently taking lorcaserin to inform them of the increased occurrence of cancer seen in the clinical trial and ask them to stop taking the medicine.
- Discuss alternative weight-loss medicines or strategies as appropriate.
The FDA is NOT recommending any special screening for patients who have taken lorcaserin.
The full drug safety communication from the FDA can be read online.
Recommendations for Patients
- Stop taking lorcaserin and talk to their health care professionals about alternative weight-loss medicines and weight management programs.
- Dispose of unused lorcaserin using a drug take back location, but if you can’t get to one you can dispose of lorcaserin in your household trash:
- Mix the pills with an unappealing substance such as dirt, cat litter, or used coffee grounds; do not crush them.
- Place the mixture in a container such as a sealed plastic bag.
- Throw away the container in your trash at home.
- Remove or delete all personal information on the prescription label of empty medicine bottles or packaging, then throw away or recycle them.
If you know of a patient who has developed cancer after taking lorcaserin, report it to the MedWatch program as recommended in the Indian Health Manual and include “IHS” in the reporter section (section G).
Instructions for reporting can be found online at the NPTC Pharmacovigilance website.