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.
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