It is common for the FDA to ask drug manufacturers for additional studies after approving the medication in question. After its initial approval, the FDA ordered Eisai Inc., the manufacturer of Belviq and Belviq XR, to conduct a study on the drug’s cardiovascular side effects. Since many weight loss medications can place stress on the heart, this additional research was necessary to prove that Belviq was not dangerous.
The resulting study did not show a higher rate of adverse cardiovascular side effects among Belviq patients. However, the data did reveal a disturbing trend among patients’ risk for cancer -- while only 7.1% of placebo patients received a cancer diagnosis, 7.7% participants in the Belviq group developed cancer over the study’s period. While this 0.6% difference may seem small, it was significant enough for the FDA to request a voluntary recall of Belviq and Belviq XR. The company complied with this request, but remains adamant that Belviq’s benefits outweigh the potential cancer risk.