According to the report published today in SILVER SPRING the U.S. Food and Drug Administration has approved a drug Fetroia (cefidecocol). It is an antibacterial drug that is used to treat the complicated cases of urinary tract infections for the patients of age having 18 years or older than this.
The drug is also able to treat some kidney infections that are usually caused by Gram-negative bacteria. The bacteria are resistant to many of the treatments so limited therapies and drugs are available to treat the infections related to this gram-negative strain bacteria.
According to the words of John Farley , M.D., M.P.H., the acting director of the office of infectious diseases in the Food and Drug Administration Center for the Drug Evaluation and Research that the approval of the drug provides the patients with cUTIs have proper treatment against the disease which previously was not possible or have limited alternative treatments.
The main challenge faced by the FDA at the global level is the increased resistant against the antibiotics that are used to treat infections such as cUTIs. The approval of this drug by FDA ensures effective safe, and quality care treatment for infectious diseases.
The drug testing was proved by a study in which the Fetroja is administrated in the 448 patients having cUTLs. 72.6% of patients show the recovery of symptoms with the elimination of bacteria after taking the drug for seven days. The results are compared with 54.6% of patients who had received another antibiotic. Both the treatment groups show the same clinical response rate.
The drug labeling warns about the higher all-cause mortality rate. The rate of mortality was higher in critically ill patients who received drug Fetroja as compare to the patients who were treated with an alternative drug. The patients are usually multidrug-resistant against gram-negative bacterial infections. The real cause of this mortality rate has not been identified.
The increased number of deaths was seen in the patients who had severe infections with complications, comorbidities and those who had acquired nosocomial infections or sepsis. The safety margins for the Fetroja has not been developed for the effective treatment of these type of infections.
The common adverse reaction related to the drug that is observed in the patients includes constipation, diarrhea, vomiting, nausea, elevations in the liver test, a yeast infection candidiasis, headache, infusion site reactions, cough, hypokalemia (low potassium).
It is prohibited to use the drug (Fetroja) in the patients who have a history of severe hypersensitivity against the beta-lactam antibiotics
The Fetroja received the certification of FDA’s Qualified Infectious Disease (QIDP) designation. Under the Generating Antibiotic Incentive (GAIN), the designation is only giving to the drugs or antibiotic or antifungal drugs which are used to treat the life-threatening infections. The drug was granted the Priority Review.
The Fetroja approval was granted to Shionogi and Co., Ltd by FDA.
Within the U.S. department of health and human services, the FDA is an organization that protects the health of the public. It ensures the safety, security, and effectiveness of human and veterinary drugs, vaccinations and related products and chemicals and medical devices. The followings are the other responsibilities of the FDA including food safety, food supply regulation to the nation, food safety, dietary supplements, regulation of tobacco products and electronic radiation products.