The license for the weight-loss drug Belviq has been permanently revoked in Taiwan, the Food and Drug Administration (FDA) said on Thursday, citing cancer risks.
The FDA in February asked that Belviq be withdrawn from the market, after the US Food and Drug Administration said that clinical trials of the active ingredient lorcaserin showed an increased risk of several types of cancer, including pancreatic, colorectal and lung cancer.
The US regulator also requested that the holder of the product’s drug license voluntarily withdraw Belviq from the US market.
Photo courtesy of the Food and Drug Administration
After receiving the warning in February, the FDA told the media that only one product containing lorcaserin — Belviq 10mg tablets — was licensed in Taiwan.
At the time, the FDA said it had asked Chuang Yi Biotech, holder of the product’s drug license in Taiwan, to suspend sales, re-evaluate the drug’s safety and recall it from the market.
However, the FDA on Thursday said that a drug safety assessment found that the risks of taking Belviq outweighed the benefits.
The FDA said that it had revoked the license for Belviq 10mg tablets and permanently banned the product in Taiwan.
Belviq, a prescription drug not covered by the National Health Insurance system, was introduced to the local market in 2017, said Medicinal Products Division head Huang Chyn-liang (黃琴喨).
Since then, about 10 million Belviq tablets have been sold to between 10,000 and 20,000 people in Taiwan, Huang said.
After Belviq was pulled from the market in February, the FDA received five reports of adverse reactions to it, including dizziness, itchy skin, sleep disorders and suspected symptoms of breast cancer, Huang added.
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