Taiwan’s Food and Drug Administration (FDA) said on Thursday that Belviq’s drug permit license has been permanently revoked. Cancer risks were cited as the reason.
Taiwan’s FDA requested Belviq’s removal from Taiwan’s market in February. The move came after the United States FDA said that clinical trials linked the drug with an increased risk of multiple cancers, including lung, colorectal and pancreatic cancers. Taiwan’s FDA said an American report found that more patients who took Belviq developed cancer than those who took a placebo, and this “numerical imbalance” increased as the duration of Belviq use increased.
U.S. regulators also asked for Belviq to be withdrawn from the U.S. market. Taiwan’s FDA said the U.S. government advised it to stop the drug’s production and take the drug off the market.
Taiwan’s FDA had told the media that only a single product containing lorcaserin possessed a permit license in the country – 10 milligram doses of Belviq. The agency had asked the holder of Belviq’s Taiwanese drug permit license to recall the drug from the market, re-evaluate the safety of the medication and temporarily suspend sales of the drug.
On Thursday, though, the agency said that a drug safety assessment concluded that Belviq’s risks outweighed its benefits. This determination led to the drug’s drug permit license being revoked and the use of the product in Taiwan being permanently banned.
Around 167,000 boxes containing 10.02 million Belviq tablets have been sold to around 10,000 to 20,000 people in Taiwan since the drug was introduced to the country in 2017, according to Huang Chyn-liang, an official with Taiwan’s FDA.
Huang said the agency received five adverse reaction reports to Belviq, including suspected symptoms of breast cancer, sleep disorder, itchy skin and dizziness, after the drug was pulled from Taiwan’s market in February.
U.S. authorities approved the drug in 2012 as an obesity medication intended to be used along with calorie restriction and an increase in physical activity. A large, randomized 2018 clinical trial found that the medication reduced the risk of kidney complications and type 2 diabetes while failing to raise cardiovascular risk.
A lawsuit filed by a New York woman claims that Belviq manufacturer Eisai, Inc. knew for years that the weight loss drug increased patients’ cancer risk, yet failed to warn consumers of this risk. The lawsuit contends that Eisai placed the medication on the market even though it knew the drug was defective, noting a study started in 2007 which found that the drug caused cancer in rats.
For more information on Belviq lawsuits, visit https://www.personalinjurylawcal.com/belviq-cancer-lawsuits/