The Ministry of Food and Drug Safety (MFDS) will add the warnings of shock and anaphylaxis to the approval conditions of 17 pain relief patches with Loxoprofen compound useful for pain and inflammation in arthritis.
The ministry announced on its website Tuesday that it would adjust the approval conditions of 17 single Loxoprofen sodium hydrate products made by 15 Korean drugmakers.
The addition says, “Shock or anaphylaxis (decrease blood pressure, rash, edema on the back of a head, and difficulty in breathing) can occur. If you suffer from these symptoms, you have to make appropriate measures, such as the suspension of intake by symptoms.”
The revision is a follow-up measure to the ministry’s review of information about the safety of drugs with Loxoprofen, announced by Japanese Pharmaceuticals and Medical Devices Agency(PMDA) in July.
Jeil Long Pap Plaster by Jeil Pharmaceutical제일헬스사이언스, Loxona Cataplasma by Daehwa Pharmaceutical대화제약, and Lenox Cataplasma by Ildong Pharmaceutical일동제약 are among products subject to new conditions. All of these products are over-the-counter drugs.
According to a report by Korean Pharmaceutical Association대한약사회, Loxoprofen recorded the highest rate of side effect in the first half of this year.
Loxoprofen accounted for 3.5 percent of total side effect reports followed by a painkiller compound Tramadol complex with 3.2 percent, and Ranitidine, Bismuth Citrate to cure brash with 2.9 percent, Following them were Mosapride with 2.8 percent, Pseudoephedrine and expectorant with 2.7 percent each and Amoxicillin and enzyme inhibitor with 2.4 percent.
The ministry will accept opinions about the change until Aug. 23.