Medical network - on April 10, recently, the state food and drug supervision and administration bureau released seventy-four bulletin of adverse drug reactions information risk warning McCaw phenolic reproductive toxicity of the drug. 

 

McCaw phenol drug is immunosuppressants, mainly a merger with ring spore element and corticosteroid use, prevent allograft kidney or liver transplantation in patients with acute rejection. McCaw phenolic drugs mainly includes McCaw phenolic acid sodium and it for 7 of phenol ester. McCaw phenolic the reproductive toxicity of drug risk continues to cause the attention of national regulators. 

 

Focus on the risk of reproductive toxicity McCaw phenolic drugs 

 

McCaw phenol drug risk of reproductive toxicity and the relevant evidence 

 

Recently, the European drug administration (EMA) issued warnings, in the choice of other prevent graft rejection drugs, taboo McCaw phenolic drug used for pregnant women, and updated in the leaflet contraindications, risk control Suggestions, etc. Update product information, emphasizes the use of this drug is effective contraceptive measures should be taken to women and men, in front of the medicine and treatment according to the need for a pregnancy test in the process, to eliminate unplanned pregnancy. 

 

EMA to McCaw phenolic product risk control measures is based on a study of it for 7 phenol ester assessment report. Because it for 7 of phenol resin after oral or intravenous drug into McCaw phenolic acids, so he phenolic acid and sodium should consider it for 7 phenolic resin products of the same risks. 

 

EMA in the assessment report pointed out that after exposure to it for he phenol ester in women, about 45-49% of pregnancies had spontaneous abortion, by contrast, in an other immune inhibitors to treat solid organ transplant patients reported incidence of 12 to 33%. Maternal exposure during pregnancy? For he phenolic ester in the fetus, report the incidence of abnormal for 23-27%, by contrast, in transplant patients accept other immunosuppressant therapy for 4-5% incidence of birth deformities, incidence of birth deformities in the total population of 2-3%. Deformity associated with it for 7 of phenol ester including ear, eye and facial deformity, congenital heart disease including the septal defect, more refers to the or and means, tracheoesophageal deformities such as esophageal atresia, effects on the nervous system, such as spina bifida, and renal abnormalities, etc. 

 

He phenolic adverse drug reaction monitoring 

 

(a) situation of adverse drug reactions monitoring database in China 

 

On January 1, 2004 to March 31, 2016, national drug adverse reaction case report database received more than 2000 cases including 7 phenols report adverse drug reactions/events, 49.6% reported serious, mainly comes from the report production enterprise collection (62.14%). Adverse reactions mainly affects the gastrointestinal system, urinary system, respiratory system, systemic damage, blood system, etc. May be associated with the risk of reproductive toxicity of case report 3 cases, 2 cases for women, adverse reactions are characterized by spontaneous abortion; 1 case for men, involving the adverse reactions of sperm abnormalities. 

 

Patients, female, 31 years old, because of the systemic lupus erythematosus (sle) in 2009 began to use it for 7 June phenol ester capsule 500 mg, at the same time take a prednisolone and hydroxychloroquine sulfate pills. Medication to March 22, 2012 or so to check found pregnant 38 days, on March 29 morning review B to exceed normal embryos, vaginal bleeding symptoms, on March 29 afternoon on March 30 patients with spontaneous abortion. 

 

In addition, our country adverse drug reaction monitoring data and Chinese literature are prompt, 7 phenols drugs in addition to manual recommended indications, there are nearly 15% report medication for a heart transplant, a bone marrow transplant hematopoietic stem cell transplantation, lung transplantation, simultaneous pancreas kidney transplantation, autoimmune diseases, including systemic lupus erythematosus (sle), with lupus nephritis, IgA nephropathy, sjogren's syndrome, etc. So he phenolic used drugs in clinical super indications, can increase the risk of reproductive toxicity. 

 

(2) the world health organization (who) adverse drug reaction monitoring database 

 

As of August 30, 2016, with active substances Mycophenolic Acid (McCaw phenolic Acid) as the search term, the world health organization (WHO) cases of adverse drug reactions report database (Vigibase) more than 25000 cases. Risk for the more than 500 cases of reproductive toxicity, report, 1000 cases involved adverse reaction performance, main show is abortion (14.4%), congenital abnormalities (8.4%), ear malformation (7.1%), gastrointestinal tract malformation (4.1%), growth retardation (3.0%), cardiac abnormalities (2.9%), cleft palate (2.8%), eye malformation (2.4%) and ventricular septal defect (2.2%), deformity (2.2%), fetal deaths (2.2%), etc. 

 

Related Suggestions 

 

National adverse drug reaction monitoring center of McCaw phenolic drug safety evaluation, think that although containing the reproductive toxicity of risk of McCaw phenolic drugs less number of cases in our country, but the risk of reproductive toxicity has been confirmed in the world. Combined with the current situation of the use of drugs in our country, and the state food and drug administration of management advice: 

 

(a) medical personnel according to McCaw phenolic instructions recommend indications to use this kind of product. Indications for manual recommended with lupus nephritis and other autoimmune disease, in view of the fact that there is no reliable evidence of evidence-based medicine, suggest that the risk of medical staff weigh the drugs to benefit, standardize the clinical use. 

 

(2) the drug production enterprises should strengthen the safety propaganda, science to promote products, in a timely manner to inform the prescription of the security information changes the doctor; Strengthen the post-market research, provide the basis for clinical rational drug use; Improve the drug instruction safety warning information in a timely manner. 

 

Q & A > > > 

 

A what are the indications and McCaw phenolic drugs? 

 

McCaw phenol drug is immunosuppressants, mainly a merger with ring spore element and corticosteroid use, prevent allograft kidney or liver transplantation in patients with acute rejection. 

 

Second, what is our country McCaw phenolic drugs? 

 

Now go on sale in China McCaw phenolic drugs including McCaw phenol sodium enteric-coated metformin hydrochloride, it for 7 of phenol ester capsules, it for 7 phenolic resin piece, it for 7 of phenol ester dispersible tablets, it for 7 phenolic resin dry suspension agent, a vial for McCaw phenolic resin. 

 

3, 7 phenols the reproductive toxicity of drug risk what are the performance? 

 

McCaw phenolic the reproductive toxicity of drug risk mainly for pregnant women to spontaneous abortion, fetal or neonatal congenital anomaly, ear deformities, gastrointestinal tract malformation, growth retardation, cardiac abnormalities, cleft palate, eye malformation, ventricular septal defect, malformation, fetal death, etc. 

 

Fourth, how to reduce the reproductive toxicity of severe adverse reactions happen? 

 

(a) suggest that the medical staff recommended according to McCaw phenolic leaflet indications using this kind of product. Indications for manual recommended with lupus nephritis and other autoimmune disease, in view of the fact that there is no reliable evidence of evidence-based medicine, suggest that the risk of medical staff weigh the drugs to benefit, standardize the clinical use. 

 

(2) the drug production enterprises should strengthen the safety propaganda, science to promote products, in a timely manner to inform the prescription of the security information changes the doctor; Strengthen the post-market research, provide the basis for clinical rational drug use; Improve the drug instruction safety warning information in a timely manner.