Medical network - on March 29th March 28, the CFDA website on the revised McCaw phenolic announcement of drug instructions, according to the decision to McCaw phenolic drugs (including:? For he command ester preparation (including tablet, dispersible tablet, capsule, dry suspension agent, injection), 7 phenol sodium enteric-coated metformin hydrochloride) specifications add black box warning, and on 【 side effect 】 and 【 taboo 】 to revise. 

 

CFDA requires all McCaw phenolic pharmaceutical production enterprise according to the relevant provisions of the "drug registration management measures" and so on, according to it for he command ester oral preparation manual revision requirements, use it for 7 injection of phenol ester specifications revision request or McCaw phenol sodium enteric-coated metformin hydrochloride revision request, put forward to revise the description of the supplement, on May 15, submitted to the provincial food and drug regulatory department for the record. 

 

Revised content involves drug label, should be revised; Specification and other contents label shall be consistent with the original approval content. Within 6 months after the supplement for the record for the factory's instructions and labels to be replaced. 

 

According to the requirements, it for 7 phenolic resin for oral preparations with a vial McCaw phenol ester all needs to increase the black box warning, the content as follows: 

 

Immunosuppressant would increase susceptibility to infection, could promote the occurrence of lymphoma and other tumors. Only to immunosuppressive therapy and to transplant patients experienced specialist can use this product, the patient should be equipped with corresponding medical equipment and laboratory personnel and can support the treatment of medical conditions to accept the goods. Responsible for long-term follow-up of patients physician should grasp the patient's comprehensive information so that the necessary follow-up for patients. 

 

Use the product of women of childbearing age must use birth control. Use this product during the pregnancy may increase the risk of miscarriage, congenital malformation, etc. 

 

The attachment > > > 

 

He phenol sodium enteric-coated metformin hydrochloride manuals revision requirements 

 

This revised requirement applies to all of China's listed McCaw phenol sodium enteric-coated metformin hydrochloride. 

 

1, 【 side effect 】 the post-marketing adverse reaction to add: 

 

Listed has been reported after the pregnancy period to accept the goods and other immunosuppressants combination therapy of patients with children, a congenital malformation. 

 

2, 【 taboo 】 : 

 

This product is pregnant women, because of its mutagenic and teratogenic. 

 

This product is not using effective contraception childbearing age women. 

 

This product is nursing mothers. 

 

Third, pregnant women and nursing mothers medication 】 【 item should include: 

 

Teratogenic effects: pregnancy category D classification (FDA) 

 

Use in pregnancy McCaw sodium phenolate, can make the abortion and increased risk of congenital malformations. Have been reported related to it for he phenolic acid ester of congenital malformation, and use it for 7 of phenol benzoate can increase the risk of spontaneous abortion. It for 7 of phenol resin after oral or intravenous drug into McCaw phenolic acids, so he phenol sodium enteric-coated metformin hydrochloride is also should be considered and it for 7 of phenol ester risk. 

 

This product prohibited for pregnant women and not using effective contraception childbearing age women. 

 

In patients with fertility, before using this product for treatment must be fully aware of this product will increase the risk of pregnancy loss and congenital malformation, must consult doctor advice on contraception and pregnancy. 

 

Patients with fertility of women before starting using this product for treatment, there must be two negative result of serum or urine pregnancy test, and the sensitivity is at least 25 mlu/mL; After the second inspection should be in the first 8-10 days, and is about to start using this product before treatment. During routine follow-up, patients should be repeated pregnancy test. The doctor should be all pregnancy test results are discussed with the patient. Patients should be fully aware, pregnant need to consult a physician immediately. 

 

Because this product has the possibility of mutagenic and teratogenic, recommend that women have fertility before starting using this product for treatment, patients during treatment and 6 weeks after the end of treatment, should be used at the same time two reliable contraceptive measures, include at least an efficient method, or choose abstinence as birth control. Suggested that sexually active after the termination of the male patients during treatment and treatment of at least 90 days to use condoms for birth control. Condoms, apply to the male patients with reproductive ability, can also be applied to vasal ligation, male patients, because vasal ligation, male patients may exist semen transport related risks. In addition, it is recommended that the male patients with female partners during the treatment, and finally a dose of this product for at least 90 days after the drug to take effective contraceptive methods. 

 

Listed has been reported after gestation period for 7 of phenol ester and other immune inhibitor combination therapy of patients with children, congenital malformation, including multiple malformations. 

 

The deformation of the most commonly reported adverse events related to, as follows: 

 

Facial deformity (such as cleft lip and cleft palate, small micromaxillary deformity and broadening apart) 

 

Ear anomalies (such as outer ear/middle ear dysplasia or absent) and ocular anomalies (such as eye tissue defects, small eye) 

 

Finger deformity (such as deformity, and more, for short) 

 

Cardiac abnormalities (for example, atrial septal defects (VSD) 

 

Esophageal abnormalities (such as esophageal atresia) 

 

The nervous system abnormalities (such as spina bifida) 

 

, according to a report in the medical literature in the use of it for 7 phenol ester in the treatment of patients with pregnancy and live birth fetal malformation rate was 23%, 27%; And in the general population, live birth fetal malformation rate was 2%; In the use of other immune inhibitors in the treatment of solid organ transplant recipients, live-birth fetal malformation rate at about 4% - 5%. 

 

After exposure to it for 7 patients with phenolic resin (mainly) in early pregnancy about abortion in the incident report. 

 

, according to a report in the medical literature in the use of it for 7 phenolic resin in the treatment of patients with pregnancy, reports of spontaneous abortion rate was 45%, 49%; But in the use of other immune inhibitors in the treatment of solid organ transplant recipients, reports of spontaneous abortion rate was 12%, 33%. 

 

Animal studies have shown that this product has the reproductive toxicity. 

 

breastfeeding 

 

Because this product may cause a serious adverse reaction of the nursing a baby, so this product is nursing mothers.