Regulators have added rhabdomyolysis – melting of cross-striated muscle – to the warnings on 210 drugs made by 98 companies, which contain gastritis-treating compound of esomeprazole.
The Ministry of Food and Drug Safety (MFDS)식품의약품안전처 Thursday ordered the change of approval conditions for medicines with esomeprazole.
The 210 products subject to changes in approval conditions are oral single tablets that contain esomeprazole, injections, and composite products with naproxen, including Nexium by Astrazeneca Korae한국아스트라제네카 and Espmezol by Hanmi Pharm한미약품.
Newly added contents to their approval conditions caution the users of esomeprazole compounds against the possibility of rhabdomyolysis, calling for them to prudently observe symptoms and suspend taking the drugs if symptoms such as muscle pain, asthenia, the increase in creatine kinase occur, and take appropriate measures.
This is a follow-up measure after Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) added rhabdomyolysis to its approval conditions in 2016.
At the time, among the Japanese patients treated with esomeprazole-containing drugs, nine reported rhabdomyolysis cases. In six of them, causal relationship could not be ruled out but there were no deaths reported.
Drugmakers with the products subject to changes in approval conditions should do so within a month or face administrative disciplines if they don’t take action.
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