Clipping Board » Drug Poisoning ─ It is necessary to be aware of the toxic side effects before taking medication.
02/26/2011 21:56 [United Daily News / Reporter Shi Jingru / Taipei Report]
A painkiller containing propoxyphene, used by 110,000 people annually in Taiwan, has been banned by the Department of Health's Food and Drug Administration (FDA) due to its risk of causing severe heart arrhythmia. The administration announced the revocation of its drug license yesterday, requiring its removal from the market.
The Department of Health also urged physicians to promptly switch patients currently using this medication to safer alternatives. Patients currently taking drugs containing this ingredient are advised to consult their doctors for a replacement.
The Department of Health has approved five drug licenses containing this ingredient, indicated for "relief of mild to moderate pain." Four of these are compound formulations combined with paracetamol and classified as Schedule IV controlled drugs. These include:
- Excellent Chemical Pharmaceuticals' "You Tong Fu Tablets"
- Boryung Pharmaceutical's "Ke Teng Tablets"
- Huangjia Chemical Pharmaceuticals' "Tong Ke Hui Tablets"
- Standard Chemical & Pharmaceutical's "Da Ke Tong Tablets"
The fifth is a single-ingredient formulation classified as a Schedule II controlled drug, produced by the FDA's pharmaceutical factory, which has ceased production in recent years.
Dai Xueyong, head of the Drug Safety Evaluation Division at the FDA, stated that painkillers containing propoxyphene have been deemed to carry cardiac toxicity risks—even potentially fatal—by both the European Medicines Agency (EMA) and the U.S. FDA, based on clinical trials and epidemiological data. These products have already been withdrawn from markets in those regions.
Dai noted that the U.S. FDA issued a warning about this ingredient in November last year. The Department of Health recently convened an expert committee meeting and concluded that although Taiwan's approved maximum daily dose (390 mg) is lower than the U.S. (600 mg) and no adverse reaction cases have been reported, concerns remain.
Elderly patients, those with poor liver or kidney function, or those taking other medications may experience drug interactions that affect metabolism, increasing blood concentration and risks. Additionally, domestic usage, prescriptions, and patient numbers have been rising annually. Given the availability of safer alternatives, the committee recommended market withdrawal, with an official revocation announcement forthcoming.
Luo Rongsheng, director of the Neuromuscular Disease Department at Chang Gung Memorial Hospital, mentioned that non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used clinically for acute pain relief. However, some patients experience gastrointestinal discomfort, leading to a switch to acetaminophen. Painkillers containing propoxyphene are rarely used in major hospitals.
Source: http://udn. com/ NEWS/ HEALTH/ HEA2/ 6154688. shtml
Propoxyphene Painkiller "Harms" Heart, Health Department Revokes License
A painkiller containing propoxyphene, used by 110,000 people annually in Taiwan, has been banned by the Department of Health's Food and Drug Administration (FDA) due to its risk of causing severe heart arrhythmia. The administration announced the revocation of its drug license yesterday, requiring its removal from the market.
The Department of Health also urged physicians to promptly switch patients currently using this medication to safer alternatives. Patients currently taking drugs containing this ingredient are advised to consult their doctors for a replacement.
The Department of Health has approved five drug licenses containing this ingredient, indicated for "relief of mild to moderate pain." Four of these are compound formulations combined with paracetamol and classified as Schedule IV controlled drugs. These include:
- Excellent Chemical Pharmaceuticals' "You Tong Fu Tablets"
- Boryung Pharmaceutical's "Ke Teng Tablets"
- Huangjia Chemical Pharmaceuticals' "Tong Ke Hui Tablets"
- Standard Chemical & Pharmaceutical's "Da Ke Tong Tablets"
The fifth is a single-ingredient formulation classified as a Schedule II controlled drug, produced by the FDA's pharmaceutical factory, which has ceased production in recent years.
Dai Xueyong, head of the Drug Safety Evaluation Division at the FDA, stated that painkillers containing propoxyphene have been deemed to carry cardiac toxicity risks—even potentially fatal—by both the European Medicines Agency (EMA) and the U.S. FDA, based on clinical trials and epidemiological data. These products have already been withdrawn from markets in those regions.
Dai noted that the U.S. FDA issued a warning about this ingredient in November last year. The Department of Health recently convened an expert committee meeting and concluded that although Taiwan's approved maximum daily dose (390 mg) is lower than the U.S. (600 mg) and no adverse reaction cases have been reported, concerns remain.
Elderly patients, those with poor liver or kidney function, or those taking other medications may experience drug interactions that affect metabolism, increasing blood concentration and risks. Additionally, domestic usage, prescriptions, and patient numbers have been rising annually. Given the availability of safer alternatives, the committee recommended market withdrawal, with an official revocation announcement forthcoming.
Luo Rongsheng, director of the Neuromuscular Disease Department at Chang Gung Memorial Hospital, mentioned that non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used clinically for acute pain relief. However, some patients experience gastrointestinal discomfort, leading to a switch to acetaminophen. Painkillers containing propoxyphene are rarely used in major hospitals.
Source: http://udn. com/ NEWS/ HEALTH/ HEA2/ 6154688. shtml