Hana Pharm’s opium pain medication, fentanyl citrate injection, had the most frequently reported side effects among biomedical products in Korea between 2013 and June 2017, statistics showed Thursday.
According to the data submitted by the Ministry of Food and Drug Safety to Rep. Kim Sang-hoon of the opposition Liberty Korea Party, Hana Pharm’s fentanyl citrate had 20,041 cases of side effect reports to become one of the top 100 drugs with the highest number of side effect reports.
Among the 100 drugs, seven were made by Yuhan Corp: Tridol Injection 50mg (ingredient: tramadol HCl) with 19,882 reports of side effects, Yuhanzid Tab. (ingredient: isoniazid) with 4,812 cases, Pyrazinamide Tab. 500mg (ingredient: pyrazinamide) with 4,578 cases, Myambutol Tab. 400mg (ingredient: ethmbutol HCl) with 3,912 cases, Solondo Tab. (ingredient: prednisolone) with 3,834 cases, and Tridol Injection 100mg (ingredient: tramadol HCl) with 3,824 cases.
Bayer Korea and Janssen Korea followed Yuhan, marketing six drugs each, followed by JW Pharmaceutical, Jeil Pharmaceutical, Hana Pharm, CJ HealthCare and Mundipharma Y.H. with four each. Ildong Pharmaceutical, Sanofi-Aventis Korea, Baxter, Dai Han Pharm, Braco Imaging Korea and Boryung Pharm had three drugs included in the 100 drugs, respectively.
The total number of reported side effects amounted to 812,425 during the five years. The number of reported side effects showed a growing trend year by year, going up from 183,260 in 2013 to 183,554 in 2014, to 198,037 in 2015, and to 228,939 in 2016. As of the end of this past June, the number reached 118,635.
When a side effect is reported, the health authorities take a safety measure after reviewing how the ingredient’s side effect is statistically meaningful and considering its domestic and overseas status. For the five years from 2013 to August 2017, the authorities ordered to take safety measures in 55 cases, involving 2,629 products.
“Although some of the side effects reported to the ministry did not show clear evidence that the involved drugs were the direct causes of the side effects, the ministry also runs the risk of omitting products that might have side effects by focusing only on the number of ill effects,” Rep. Kim said.
The government should not just focus on the frequency of side effects or those that draw social attention only but also enhance workforce and system to curb the rising number of side effects and deal with the issue thoroughly, he added.