Hainan recalled three batches of progesterone injection of hundreds of patients injected with lumps

Xiaoli injection of progesterone parts of the emergence of red lumps
Injection of progesterone parts of the emergence of red lumps. Patients provided by Guangzhou manufacturers of progesterone injection. Hainan Province Food and Drug Administration announced today that the province has been asked to suspend the use of medical institutions 3 batik progesterone injection, and urge enterprises involved in the recall of 13980 injections. According to the Bureau of detection, in addition to sterile test items to be cultured for 14 days to determine the results of other projects are in line with the provisions of the test. Prior to the media reported that more than 400 patients in Hainan and Beijing Reproductive Hospital, Guangzhou Baiyun Mountain Ming Hing Pharmaceutical Co., Ltd. production of progesterone injection, 142 people local redness, induration and other adverse reactions. (North Green newspaper reporter Lu Chang) News Review: Hainan 142 pregnant women hospital play luteinone hit lumps April 19 this year, test tube baby transplant success of the small Mary just immersed in the joy of mothers, the child stopped developing. Eventually she can only give up. A month later, Mary injection of progesterone parts of the emergence of red lumps. She also found that many of the pregnant women who had received test-tube infants in Hainan and Beijing Reproductive Hospital (hereinafter referred to as "Hainan and Beijing Hospital") had the same symptoms as her. In Xiaoli (a pseudonym) and so on more than 100 patients "progesterone rights group" micro-credit group, we suspect that the use of the hospital in Guangzhou Baiyun Mountain Ming Hing Pharmaceutical Co., Ltd. production of progesterone injection problems. In this regard, the hospital that may be poor absorption of adverse reactions caused by injection; manufacturers said that there is no problem with the injection of drugs involved in the case may be overdose use of the hospital situation. Southern Metropolis Daily reporter Meng Jian A patient crying to replace the infusion after the baby did not introduce Mary, she went to the end of Hainan and Beijing Hospital to take test tube transplant, injection to promote ovulation needle. After the Spring Festival this year, that is, March 2 began to transplant, while injection of progesterone. "I was injected with a manufacturer of Zhejiang progesterone injection, half a month later, the blood test to determine my pregnancy." Not long after, Hainan and Beijing Hospital gave her to replace the Guangzhou Baiyun Mountain Ming Hing Pharmaceutical limited The company produces progesterone injection. Xiaoli said, just change the injection, the needle is difficult to hit into the buttocks have the feeling of itching. "The hospital said Zhejiang manufacturers of progesterone injection is not." Xiaoli told reporters that the injection of Guangzhou manufacturers of progesterone after 5 days, she went to the hospital blood examination found that the body of progesterone decreased, the original pregnant with the Vomiting and other reactions did not, the doctor continued to give her twice the Guangzhou manufacturers of progesterone. Xiao Li said that she injected these doses of progesterone, in the B-ultrasound was told when the progesterone is still down, the baby is developing slowly. "The doctor still continued to open the Guangzhou factory's injection." Mary said that the last check, progesterone index fell very powerful, belly baby also stopped developing. April 19, sad disappointed Mary can only do the flow of people. A month later, the location of injection injection swelling, lumps, lumps slowly expanded to the thigh. "As a long time, the doctor said puncture and cupping are difficult to deal with, I do not know how to do now." B survey to understand more than 100 people with the injection of adverse reactions in the interview process found that such as Mary Response to the patients there are many. A woman pulled the reporter called "progesterone rights group" WeChat group, the group members of more than 120 people, are recently in Hainan and Beijing Hospital to take test tube transplant and the emergence of symptoms of patients, we also injected Guangzhou manufacturers of progesterone. The micro-group from time to time to join new members. Members of the photos made shocking: the photos are mostly red and even festering parts. Reporters randomly contacted two of the patients. Li Xue (a pseudonym): March 20 began to take test tube baby transplant, April 18 injection of Guangzhou manufacturers of progesterone. "Injection did not take long, the injection site appeared lump." She stopped at the end of June after injection, the location of the lumps out of multiple lumps, but also accompanied by swelling and pain symptoms. Li Xue is now most worried about is that she has been pregnant for two months, do not know the needle will not have an impact on the baby. A flower (a pseudonym): April 23 this year in Hainan and Beijing Hospital to take test tube transplant, and began to use Guangzhou manufacturers of progesterone injection, until May 7. "At the end of May, my buttocks showed redness and tenderness, and the feet were numb." The position of the injection was clearly hardened by hand pressure. Spent more than 40,000 yuan, did not expect such a thing happened, A flower worry about the injection will cause other adverse reactions in the body. C and the Beijing hospital may be poor absorption of drugs led to a patient in the packaging of drugs, the reporter saw that this is a by Baiyun Mountain in Guangzhou Ming Hing Pharmaceutical Co., Ltd. in January 28, 2016 production of progesterone injection Liquid, batch is 150909. What is the cause of adverse reactions in patients with the progesterone injection? Reporters found the hospital in Hainan and Beijing Li long. "Our hospital with progesterone 10 years, the first time there are so many people appear abnormal situation." Li said the hospital previously used a factory in Zhejiang, progesterone injection, the end of March this year, Zhejiang manufacturers of progesterone Out of stock, by the recommendation, they purchased from the two companies in Guangzhou this company produced progesterone. "Our patients live scattered, and some in the hospital injection, and some take home injection." Li said that the beginning of the patient did not receive adverse reactions to the situation, until the beginning of June, a patient in the hospital "Patient WeChat group" reflects the location of the injection of swelling and pain, followed by several patients also feedback this situation. "The chief physician learned of the situation and reported to me and began to visit the patient, the results found that most patients have similar symptoms." Li said that he began to think that the injection of adverse reactions, but with the increase in the number of statistics , There are 142 cases of abnormal symptoms of the patients, the need for more than 10 individual treatment. Li Zhizhong suspected the injection of the problem, the urgent use of the previous use of Zhejiang manufacturers of progesterone, June 18 to stop the use of Guangzhou manufacturers of injection, and contact with the manufacturers. "July 5, the manufacturers feedback to us the test report, the indicators are qualified." Li told reporters that patients with abnormal symptoms, and manufacturers insisted that the drug no problem, July 12, he was bad medicine to Hainan Province Response monitoring center and the Hainan Provincial Health Commission to reflect the food and drug supervision departments have been involved in sampling samples of samples for testing. Li said that the initial investigation, the pharmacy with 4049 boxes of a total of 40,000, the symptoms are using the 160111 and 160206 two batches of patients, a total of 3400 boxes. He believes that the injection should be incomplete, the injection of local tissue stimulation caused by the emergence of reactive inflammation of the adverse reactions. "Normal medicine can not be absorbed two months." Li said the president. It is understood that the progesterone is due to oily injection, the body absorption is not good when the situation has occurred, the hospital has informed the patient free treatment, but the effect is not good, part of the reaction of patients with severe swelling, ulceration symptoms. After the hospital took a puncture cupping approach. "Some patients are willing to receive treatment, some patients are excited to refuse treatment." For the case of abortion, Li said that there is no conclusion that the use of the injection will lead to abortion. D injection manufacturers suspected of hospital overdose use for the Hainan and Beijing hospital to reflect the situation, in early July this year, Guangzhou Baiyun Mountain Ming Hing Pharmaceutical Co., Ltd. Quality Management Department issued a "on the progesterone injection of the note": the company Organization of self-examination related products, the whole process of production inspection, and re-examination of the relevant products to stay, the results show that the batch production process to meet the requirements of the production batch records complete, no abnormal situation. In the case description also shows: "In the clinical use of the product, some patients use a longer period of time, the greater the injection dose, the more likely to form induration, such problems in the product specification 'adverse reactions' and other items described in detail ... ... "15, the reporter contacted the Guangzhou Baiyun Mountain Ming Hing Pharmaceutical Co., Ltd. Sales Manager Wu Jingli. Wu Jingli introduction, their raw materials procurement, pharmaceutical production are all strictly tested, each batch of injection has a corresponding quality inspection report, and also did not receive other areas of adverse reactions reported. Wujing Li said the company suspected that Hainan and Beijing hospitals in the use of drugs did not follow the relevant provisions. The hospital said before using another manufacturer of the injection did not appear problems, from the characteristics of injection, they produce progesterone injection and the hospital previously used another manufacturer is different. "Our progesterone injection has 'benzaldehyde', is an analgesic, medication guide that should be deeply into the muscle." Wujing Li said that their injection of a 20 mg, just when the injection is a bit Hemp feeling, post-injection care is very important, which is different from other manufacturers. He understood that Hainan and Beijing hospitals use their injections for allegedly overdose use, but whether there is such a behavior still requires further investigation by the relevant departments. E regulatory authorities need to wait for the results of the two weeks on July 12, Hainan Province, adverse drug reaction monitoring center in that the situation is very important, the Joint Provincial Food and Drug Inspection Bureau of the Beijing and the hospital used in Guangzhou Baiyun Mountain Ming Xing Pharmaceutical Co., Ltd. production of progesterone injection samples, sent to the detection of drug testing in Hainan Province. The director of the center Li Yunda introduced, progesterone is a natural progesterone secreted by ovarian corpus luteum, in the body of estrogen-induced endometrial significant morphological effects, in order to maintain pregnancy necessary. "Progesterone is from the muscle injection, excipients containing soybean oil, oil absorption is slower, if the injection is more difficult to absorb." Li Yunda told reporters, whether the need for further testing of qualified. To carry out aseptic culture observation, it takes 14 days to get the results. Has been reported to the National Drug Adverse Drug Reaction Monitoring Center.


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