viernes, 14 de febrero de 2020

FDA requests the withdrawal of Belviq, Belviq XR (lorcaserin) from the market - Drug Information Update

https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-weight-loss-drug-belviq-belviq-xr-lorcaserin-market?utm_campaign=FDA%20requests%20the%20withdrawal%20of%20the%20weight-loss%20drug%20Belviq%2C%20Belviq%20XR%20%28lorcaserin%29&utm_medium=email&utm_source=Eloqua
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FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market
The U.S. Food and Drug Administration (FDA) has requested that the manufacturer of Belviq, Belviq XR (lorcaserin) voluntarily withdraw the weight-loss drug from the U.S. market because a safety clinical trial shows an increased occurrence of cancer. The drug manufacturer, Eisai Inc,. has submitted a request to voluntarily withdraw the drug.

We are taking this action because we believe that the risks of lorcaserin outweigh its benefits based on our completed review of results from a randomized clinical trial assessing safety.

In January 2020, we announced we were reviewing clinical trial data and alerted the public about a possible risk of cancer associated with lorcaserin based on preliminary analysis of the data.

Patients should stop taking lorcaserin and talk to your health care professionals about alternative weight-loss medicines and weight management programs. It’s best to 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.

FDA is not recommending special screening for patients who have taken lorcaserin. Talk to your health care professional if you have questions.

Health care professionals should stop prescribing and dispensing lorcaserin to patients. Contact patients currently taking lorcaserin, 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 with your patients.

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