The Food and Drug Administration (FDA) announced that it is considering allowing the use of amphetamine-like drug fenfluramine to treat forms of epilepsy that are otherwise difficult to treat and resistant to traditional anti-epileptic drugs.
Amphetamine-like substances are banned in Taiwan, with the import, manufacture and sale of fenfluramine prohibited in 1980, when all licenses for its use were revoked, Medicinal Product Division deputy head Lin Yi-chu (林意筑) said today.
The FDA, under the Ministry of Health and Welfare (MOHW), on Tuesday announced draft revisions to the regulations on amphetamine-like substances and their derivatives, with a 14-day window for public comment.
Photo: Chung Li-hua, Taipei Times
Fenfluramine was previously used for weight loss, with many countries removing it from the market following clinical trials that showed it can cause side effects, including valvular heart disease, Lin said.
However, research has shown that controlled use of the drug is effective in treating Dravet Syndrome and Lennox-Gastaut Syndrome, rare forms of epilepsy otherwise difficult to treat, she said.
Since 2020, the US, Europe and Japan have gradually approved it for controlled use, she added.
Repeated seizures can hinder normal development and cause neurological impairments, leading to a higher mortality rate and impacting the quality of life of caregivers, she said.
Several organizations in Taiwan, including the Taiwan Foundation for Rare Disorders, the Taiwan Epilepsy Association and the Taiwan Child Neurology Society, have petitioned that the FDA approve the use of fenfluramine, she said.
After consulting medical societies and medical professionals, the FDA is considering approving fenfluramine and its salt to treat these two rare syndromes, she said.
Amphetamine-like drugs are central nervous system stimulants that may cause symptoms such as restlessness, dizziness, tremors, hyperactivity, insomnia, anxiety and delirium, the draft regulation said.
They are also addictive and can cause increased tolerance in patients, it said.
Amphetamine-like substances would still be strictly controlled under the Pharmaceutical Affairs Act (藥事法), including amphetamine, dexamphetamine, methamphetamine, phendimetrazine, diethylpropione and fenfluramine, it said.
The manufacture of the remaining 28 M1A2T Abrams tanks Taiwan purchased from the US has recently been completed, and they are expected to be delivered within the next one to two months, a source said yesterday. The Ministry of National Defense is arranging cargo ships to transport the tanks to Taiwan as soon as possible, said the source, who is familiar with the matter. The estimated arrival time ranges from late this month to early next month, the source said. The 28 Abrams tanks make up the third and final batch of a total of 108 tanks, valued at about NT$40.5 billion
Two Taiwanese prosecutors were questioned by Chinese security personnel at their hotel during a trip to China’s Henan Province this month, the Mainland Affairs Council (MAC) said yesterday. The officers had personal information on the prosecutors, including “when they were assigned to their posts, their work locations and job titles,” MAC Deputy Minister and spokesman Liang Wen-chieh (梁文傑) said. On top of asking about their agencies and positions, the officers also questioned the prosecutors about the Cross-Strait Joint Crime-Fighting and Judicial Mutual Assistance Agreement, a pact that serves as the framework for Taiwan-China cooperation on combating crime and providing judicial assistance, Liang
A group from the Taiwanese Designers in Australia association yesterday represented Taiwan at the Midsumma Pride March in Melbourne. The march, held in the St. Kilda suburb, is the city’s largest LGBTQIA+ parade and the flagship event of the annual Midsumma Festival. It attracted more than 45,000 spectators who supported the 400 groups and 10,000 marchers that participated this year, the association said. Taiwanese Designers said they organized a team to march for Taiwan this year, joining politicians, government agencies, professionals and community organizations in showing support for LGBTQIA+ people and diverse communities. As the first country in Asia to legalize same-sex
MOTIVES QUESTIONED The PLA considers Xi’s policies toward Taiwan to be driven by personal considerations rather than military assessment, the Epoch Times reports Chinese President Xi Jinping’s (習近平) latest purge of the Chinese People’s Liberation Army (PLA) leadership might have been prompted by the military’s opposition to plans of invading Taiwan, the Epoch Times said. The Chinese military opposes waging war against Taiwan by a large consensus, putting it at odds with Xi’s vision, the Falun Gong-affiliated daily said in a report on Thursday, citing anonymous sources with insight into the PLA’s inner workings. The opposition is not the opinion of a few generals, but a widely shared view among the PLA cadre, the Epoch Times cited them as saying. “Chinese forces know full well that
RSS