Previously, pharmacists who had received much attention questioned that Pidotimod, a "magic medicine", had made new progress. Ji Lianmei, a former pharmacist of Hemujia, believes that there is a lack of high-quality and reliable clinical research to confirm the effectiveness and safety of the drug, and there is abuse. The State Food and Drug Administration announced yesterday that in order to further protect the public’s medication safety, china food and drug administration decided to revise the instructions of pidotimod preparation, narrowing the scope of indications and explicitly pointing out that children under 3 years old are prohibited.
Event review:
Pharmacists questioned Pidotimod, a "magic medicine", attracting attention.
In December last year, Ji Lianmei, then a pharmacist at Hejia Hospital, issued a document questioning Pidotimod, a widely used pediatric "magic medicine". Ji Lianmei said in the article that parents often ask Pidotimod at work. On a medication platform, Ji Lianmei found that the drug is the darling of pediatricians, otolaryngologists and dermatologists. Almost every child who comes out of these three departments has the figure of Pidotimod on his medication list, and the assembly line generally prevents a box of colds, a box of fever and cough, a box of rhinitis and tonsillitis, and a box of eczema and urticaria … …” And "the unit price of each box ranges from tens to hundreds of yuan, and it is a month’s amount when it is opened, and a three-month course of treatment when it is eaten."
However, such a "pediatric best-selling drug" lacks high-quality and reliable clinical research, and its clinical efficacy and safety are not clear. This is the conclusion reached by Ji Lianmei after consulting a large number of authoritative data at home and abroad. At the same time, Ji Lianmei pointed out that the data show that in 2016, the sales of Pidotimod in domestic grade hospitals reached 3.5 billion, and the sales in retail pharmacies reached 427 million. Together with the sales in other non-grade hospitals, Ji Lianmei speculated that the total amount would reach 4 billion, and most of them were paid by children. After the article was published, it aroused social concern.
Latest progress: the General Administration of Food and Drug Administration revised the instructions of Pidotimod.
Yesterday, the State Food and Drug Administration issued an announcement and decided to revise the instructions of pidotimod preparations (including pidotimod tablets, powders, dispersible tablets, oral solutions, oral liquids, capsules and granules).
According to the revised information provided by the State Food and Drug Administration, the indications of pidotimod after revision are only used for the adjuvant treatment of chronic or recurrent respiratory tract infections and urinary tract infections, and other acute infections, otorhinolaryngology infections and gynecological infections are deleted. At the same time, adverse reactions have also increased. The following adverse reactions can be observed by post-marketing monitoring and literature: digestive system damage: occasional nausea, vomiting, diarrhea, abdominal pain, stomach discomfort, dry mouth, abdominal distension, abnormal appetite, heartburn, and rare liver aminotransferase increase; Damage to skin and its accessories: occasionally it may cause skin allergy (including rash and itching), skin flushing, etc. In severe cases, skin and mucosal ulcers may be rare; Nervous system damage: occasional dizziness, headache, dizziness, etc. Others: occasional chest tightness, fever, lethargy, palpitation, facial edema, lip edema, etc. It is worth noting that this revision clearly States that the drug is prohibited for children under 3 years old. In terms of usage and dosage, it is stipulated that children and adolescents aged 3 and above should be given 0.4g each time, twice a day, and no more than 60 days. Adults: 0.8g each time, twice a day, no more than 60 days.
The State Food and Drug Administration requires that all manufacturers of pidotimod preparations should submit supplementary applications for revision of the instructions in accordance with the relevant provisions of the Measures for the Administration of Drug Registration and the template of the instructions for pidotimod preparations, and report them to the provincial food and drug regulatory authorities for the record before April 30, 2018.
If the revision involves drug labeling, it shall be revised together; Other contents of the instructions and labels shall be consistent with the original approved contents. Replace all drug instructions and labels that have left the factory within 6 months after the supplementary application is filed. Each pidotimod preparation production enterprise shall carry out in-depth research on the mechanism of new adverse reactions, take effective measures to publicize and train the use and safety issues, and guide doctors to use drugs rationally. Clinicians should carefully read the revised instructions of pidotimod preparation, and make full benefit/risk analysis according to the newly revised instructions when choosing drugs. Patients should strictly follow the doctor’s advice and read the instructions carefully before taking the medicine.
Text/reporter Zhang Xiaomei
Dialogue:
The pharmaceutical factory has been bothering me for six years when it was more serious with the "magic medicine"
Dialogue: Questioning the article of Pidotimod — — "Pidotimod, which sells 4 billion yuan a year, please leave China children alone! The author is Ji Lianmei, a former pharmacist at United Family Hospital.
Yesterday, after the announcement, the reporter of Beiqing Daily contacted Ji Lianmei who had just resigned from Hejia Hospital for the first time. Ji Lianmei was very excited after learning the news. After carefully reading the official revision, she reviewed with the reporter of Beiqing Daily the "road of questioning the magic medicine".
Beiqing Daily: When did you start to pay attention to Pidotimod?
Ji Lianmei: The earliest article about Pidotimod in Weibo was published in May 2012. At that time, the background was like this: in 2011, I started to do medicine popularization. In 2012, a Weibo netizen asked me if this medicine could treat eczema, which was definitely not symptomatic, so I replied to him. Weibo’s content is the record at that time. Later, people kept asking questions about Pidotimod, and I took pains to reply one by one. Doubts about Pidotimod also arose in this process.
Beiqing Daily: What preparatory work did you do before you officially issued a question?
Ji Lianmei: "Selling 4 billion pidotimod a year, please let the children of China go!"! This article was published on December 18th last year. Before this article, we "asked the pharmacist team" to cooperate with another article, which was posted in Lilac Garden. Under that article, some readers left a message hoping to talk about "Pidotimod". We asked how many people paid attention to this medicine and saw more than 2,000 likes. So we decided to study this medicine carefully and find out it thoroughly. In the next four days, I organized the pharmacists of the "Ask Pharmacists Team" to search the literature together. Two pharmacists, Mou Jinjin and Xu Shixi, together with me, completed a large number of literature searches at home and abroad, covering all authoritative drug data websites at home and abroad, and finally I wrote the manuscript.
Beiqing Daily: After the questioning, the social attention was very high. Were you under pressure at that time?
Ji Lianmei: There is a lot of pressure. Others questioned that I thought I was wrong, or questioned that the data we were looking for was wrong. Pharmaceutical companies are also constantly picking on me. A friend told me that pharmaceutical companies would sue me.
Beiqing Daily: When did you learn the news of the official revised manual? How do you feel that the question has been officially recognized?
Ji Lianmei: You are the first to tell me the news. I am very, very happy to see the official voice revision! In response to the official revision of the instruction manual, I saw the progress of drug supervision in China. As a pharmaceutical professional, this is the motivation that can keep me on this road.
Beiqing Daily: What do you think are the most noteworthy changes in this revision?
Ji Lianmei: In this revision, the most noteworthy change is the indication. Its indications have narrowed. According to the original indications, it is an immunomodulator, which can be used for people with low immunity. Many doctors will classify children into this category, and parents will think that it is an immunomodulator and can be used for children.
After revision, the indications of pidotimod are only used for the adjuvant treatment of chronic or recurrent respiratory tract infections and urinary tract infections, and other acute infections, otorhinolaryngology infections and gynecological infections are deleted. It is also very important to limit the crowd. After the revision, Pidotimod is no longer used for children under 3 years old. I think this is very meaningful. Because children under the age of 3 are also more common to have repeated infections, and in the foreign materials I consulted before, Pidotimod was used for repeated respiratory infections, and there is no data on children under the age of 3.
Text/reporter Zhang Xiaomei Image source/network
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