Reported by Yeh Hui-Xuan

Due to the rise of concern over carcinogens found in some antihypertensives, the TFDA took a precautionary action to recall tens of thousands of affected products from the market.  The Consumers’ Foundation urged the TFDA to toughen the drug safety policy, and make the regulations as stringent as those for food safety, as well as fully implement the annual sampling and inspection mechanism.

Since last year, there have been reports about carcinogens, such as NDMA and NDEA, found in sartan manufactured in China and India. Sartan is an active substance of antihypertensives.   As a precautionary measure, the TFDA requested drug companies to recall all products in concern.  Lei Li-Fen, the President of the Consumers’ Foundation, pointed out that these incidents raise the alarm about drug companies’ use of cheap APIs imported from China and India in order to survive the global price competition.

As cost becomes drug companies’ major concern, the government should strengthen the control over the supply sources and the manufacturing process of APIs in order to ensure their safety, said Lei.  She also expressed her concerns that the NHI drug price cut might have exacerbated the situation.  The Consumers’ Foundation reminded patients on antihypertensives to consult their doctors about their medication and whether it is necessary to change prescriptions.  Patients should not stop taking medicines without talking to their doctors first.

According to the US FDA’s announcement, the amount of NDMA and NDEA found in drugs is within the safety limit, and there has been no evidence of carcinogenicity.  However, Lei Li-Fen pointed out that the long-term effect is still unknown, as toxic substances may accumulate in human body.  Though it may seem safe at the moment, no one knows what would happen in the future.  

The Consumers’ Foundation suggested that patients who took the drugs in question should have a health check on a regular and long-term basis.  The data should be compared with the data of those who are not affected by the questionable drugs so as to fully evaluate the risk of carcinogenicity.

【2019-03-26 / United Evening News】