The safety of Cempra's macrolide antibiotic sothithromycin was questioned by the FDA November 4, 2016 Source: US and Chinese medicine source The FDA has published a question on its website about the safety of Cempra's macrolide antibiotic solithumycin. The FDA believes that although solithromycin shows and compares the non-inferiority of moxifloxacin in clinical trials of community pneumonia , multiple hepatotoxic signals have been shown in smaller populations, including elevated transaminases. The FDA panel will discuss the listing of solithiromycin on Friday, and the PDUFA will be available at the end of December this year. Coupled with recent production problems, today's news has caused Cempra shares to fall 60%. Solithromycin is a macrolide antibiotic that is very similar to the structure of another well-known macrolide, Telithromycin (trade name Ketek). When Ketek went on the market, it was very popular with doctors because the upper respiratory tract infection was very effective. Unfortunately, this product can cause severe liver damage, and a major doctor involved in clinical trials is suspected of falsifying data, and Ketek's label is reduced by the FDA . The shadow of Ketek is one of the key factors that Solithromycin has been questioned. In fact, in the largest phase III clinical trial , the third- and fourth-grade transaminase elevations in the Solithromycin group were 4.6% and 0.5%, respectively, compared with 2.1% and 1.2% in the moxifloxacin group, respectively, in the most severe quaternary response control. The group is higher. Elevase transaminase is a common feature of all macrolide antibiotics , and even a large amount of azithromycin has this side effect. In the 1990s, Pfizer had a long-term clinical trial of azithromycin to prevent heart disease. More than 4,000 people had not been severely hepatotoxic for one year, and the indication for Solithromycin was a short-term upper respiratory infection. In addition, elevated transaminase is only transcendental, so the chance of liver damage is small. About seven-tenths of the patients had hepatitis after using Ketek, but the product was not withdrawn and used to treat pneumonia. Previously, 1-2 thousand patients have used Solithromycin, but no drug-induced hepatitis has been found. It seems that Solithromycin is no safer than Ketek. Of course, such rare side reactions require a large number of patients to observe, even if the FDA approves the listing of Solithromycin, there may be additional conditions such as black box warning and four-stage clinical follow-up. Solithromycin is essentially a me-too drug that can be approved immediately if there is no clear distinction between the FDA and the FDA . On the other hand, antibiotic research and development is currently at a low tide, and the antibiotic resistance that will occur sooner or later is not enough for the entire society. Therefore, the FDA has to protect the enthusiasm of a small number of companies looking for new antibiotics. The FDA's external expert group may differ greatly from the FDA's internal views. The FDA also said that if the expert group gives positive comments, they will seriously consider it, so this product does have many variables.
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The safety of Cempra's macrolide antibiotic sothithromycin was questioned by the FDA