On May 8, the CFDA issued the latest edition of the report on adverse drug reactions, warning of the misuse risk of methotrexate. 

 

Methotrexate is an inhibitor of folate reductase, which is mainly used in cancer and immunotherapy. In recent years, foreign drug regulatory departments issued several messages to remind methotrexate piece for treating other disorders such as rheumatoid arthritis by mistake when change the dosing frequency poisoning, and even death. Our country adverse drug reaction monitoring database and the analysis of relevant literature, according to the situation in our country there are errors for patients using methotrexate lead to poisoning cases occurred. 

 

First, the foreign pharmaceutical supervisory department reported the safety of the methotrexate 

 

On July 21, 2016, the Swiss department of therapeutic products issued an important safety message to prevent patients with rheumatoid arthritis and psoriasis from overusing methotrexate. , according to the information methotrexate for rheumatoid arthritis and psoriasis medicine method for once a week, unlike conventional drug delivery methods, the Swiss have patients took methotrexate by using frequency modulation for daily use. 

 

Between January 1997 and July 2015, the Swiss treatment products bureau received 18 cases took methotrexate daily use and cause of poisoning cases, most of oral medicine, individual to subcutaneous dosing, and 4 patients died. Toxic behavior includes mucosa, oral inflammation, diarrhea, vomiting, skin lesions, fever, hemorrhagic events, abnormal weakness or fatigue (due to bone marrow suppression). Drug errors can occur at any stage of the treatment period or during the treatment period. Medication errors can be caused by changes in drug dosage forms, medical institutions and caregiver changes. Medication errors in prescription, carers or family members to take the medicine, the patient's own drug use and so on each link, the communication between medical staff and patients is an important reason of medication errors. 

 

Swiss treatment products bureau issued new measures to solve the problem of the above misuse, CARDS, including providing patients/pharmacists were given to patients by doctors and indicate the date of the weekly drug use, drug overdose symptoms and related processing advice and other information; On the product box, add "for example rheumatoid arthritis and psoriasis," the black box warning is used once a week. Use the contents of the instruction manual, and use the highlighted color and black box to highlight the use of the first weekly treatment of methotrexate in non-tumor indications. 

 

In January 2017, the ministry of health of Canada also issued the safety information on the incorrect use of methotrexate. Health Canada suggest methotrexate oral preparations manufacturers added in the product label "check - methotrexate dosage and number is usually use for 1 times a week" warning information. 

 

In the case of methotrexate in our country 

 

(1) the situation of the domestic drug adverse reactions database 

 

On January 1, 2004 to September 30, 2016, national adverse drug reaction monitoring center case report database retrieval to methotrexate case report of 1249 cases, including 1 case report entitled as "drug dosage error" adverse reactions, 1 patients with rheumatism mistaking methotrexate slice of daily use, a total of 5 days (correct usage should be 1 times a week, one of 7.5 mg), resulting in lack of granulocyte, thrombocytopenia performance, such as poisoning patients died. 

 

(2) domestic documents 

 

Retrieval China hownet, ten thousand medical literature database, involving more than about patients taking methotrexate lead to poisoning of literature reports, poisoning manifestations including oral ulcers, gastrointestinal bleeding, fever, skin lesions, bone marrow suppression, liver damage, etc. 

 

suggestion 

 

(1) from the present evaluation, the correct use of methotrexate is more beneficial than risk. But with both at home and abroad with methotrexate dosage or frequency error and the misuse of poisoning cases, suggest that physicians and pharmacists fully recognize and pay attention to the possible problem of patients using the wrong product, to long-term should do well in patients treated with methotrexate piece of guidelines, to the patient and family to clear and to emphasize this the right way. 

 

(2) using methotrexate piece of patients should be carefully read the instructions, in strict accordance with the usage and dosage of doctors' prescriptions on methotrexate, not to change. At the same time, it is recommended that the patient follow the doctor's order and do not stop the medicine without taking the medicine, so as not to delay the treatment of the disease.