Positive: Professionalism , Responsiveness How does one improve upon a professional team? Perhaps more interaction with the attorney necessary, but paralegals are quite competent.
Gordon Wilson
3 years ago
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) claims that a safety trial for the weight-loss drug lorcaserin, sold by the brand name Belviq and Belviq XR, proved that taking the drug increases the risk of developing cancer. As a result of the FDA’s interpretation of the trial results, Eisai, the maker of […]
Weight loss drugs Belviq
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) claims that a safety trial for the weight-loss drug lorcaserin, sold by the brand name Belviq and Belviq XR, proved that taking the drug increases the risk of developing cancer. As a result of the FDA’s interpretation of the trial results, Eisai, the maker of Belviq, voluntarily agreed to pull the drug from circulation for the time being. According to the Miami Herald, lorcaserin was designed to help people battling obesity to lose weight by curbing their appetite. Eisai manufactured lorcaserin to work in conjunction with a diet and exercise regimen. Eisai maintains that the drug is safe but agreed to the recall demand made by the FDA.
The FDA conducted safety trials of Belviq and Belviq XR to ascertain the drugs’ potential effect on the patients’ hearts. However, the FDA found no discernable trend regarding cardiac issues caused by lorcaserin. Instead, the FDA believes it discovered a link between lorcaserin and cancer. Eisai does not agree with the conclusion the FDA drew from those studies. Notwithstanding, the company decided to pull the drug from circulation. Eisai made it clear that agreeing to the recall is not the equivalent of conceding that the drug is dangerous or capable of causing cancer.
For now, patients who were prescribed Belviq or Belviq XR must stop taking the drug immediately and consult their doctor about safer alternatives. The FDA believes that the heightened risk of developing cancer from taking lorcaserin substantially outweighs the weight loss benefit of the drug. The FDA based its findings on a study of 12,000,000 people who showed more people in the study were on lorcaserin and developed cancer compared to those who only took a placebo. Some of the patients in the study group who received lorcaserin developed colorectal, pancreatic, or lung cancer.
Eisai disagrees with the FDA interpretation of the data and still believes that the drug’s significant benefits outweigh the risks.