The FDA approved Merck’s Recarbrio today, a three-drug combination antibiotic injection for the treatment of hospital-acquired bacterial pneumonia, or HABP, and ventilator-associated bacterial pneumonia, or VABP, in patients aged 18 years and older, according to a press release from the FDA.
“As a public health agency, the FDA addresses the threat of antimicrobial-resistant infections by facilitating the development of safe and effective new treatments,” Sumathi Nambiar, MD, MPH, director of the division of anti-infectives in the Office of Infectious Disease in FDA’s Center for Drug Evaluation and Research, said in a press release. “These efforts provide more options to fight serious bacterial infections and get new, safe and effective therapies to patients as soon as possible.”
Researchers evaluated the efficacy and safety of Recarbrio in a randomized controlled trial of 535 hospitalized adults with HABP/VABP due to gram-negative bacteria in which 266 were given Recarbrio and 269 were given piperacillin-tazobactam. Results showed that 16% of the patients given Recarbrio and 21% of patients given piperacillin-tazobactam died through day 28 of the study.
Common adverse reactions in patients treated with Recarbrio included increased liver enzymes, diarrhea, anemia, hypokalemia and hyponatremia. Clostridioides difficile-associated diarrhea has occurred with nearly all antibacterial agents, including Recarbrio, and may range in severity from mild diarrhea to fatal colitis, according to the release.
The FDA emphasized that patients should be evaluated for prior hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta-lactam agents and other allergens before starting Recarbrio. The agency also noted that Recarbrio should not be used in patients who are prone to seizures and other central nervous system disorders.
Source URL: Read More
The public content above was dynamically discovered – by graded relevancy to this site’s keyword domain name. Such discovery was by systematic attempts to filter for “Creative Commons“ re-use licensing and/or by Press Release distributions. “Source URL” states the content’s owner and/or publisher. When possible, this site references the content above to generate its value-add, the dynamic sentimental analysis below, which allows us to research global sentiments across a multitude of topics related to this site’s specific keyword domain name. Additionally, when possible, this site references the content above to provide on-demand (multilingual) translations and/or to power its “Read Article to Me” feature, which reads the content aloud to visitors. Where applicable, this site also auto-generates a “References” section, which appends the content above by listing all mentioned links. Views expressed in the content above are solely those of the author(s). We do not endorse, offer to sell, promote, recommend, or, otherwise, make any statement about the content above. We reference the content above for your “reading” entertainment purposes only. Review “DMCA & Terms”, at the bottom of this site, for terms of your access and use as well as for applicable DMCA take-down request.
Acquire this Domain
You can acquire this site’s domain name! We have nurtured its online marketing value by systematically curating this site by the domain’s relevant keywords. Explore our content network – you can advertise on each or rent vs. buy the domain. Buy@TLDtraders.com | Skype: TLDtraders | +1 (475) BUY-NAME (289 – 6263). Thousands search by this site’s exact keyword domain name! Most are sent here because search engines often love the keyword. This domain can be your 24/7 lead generator! If you own it, you could capture a large amount of online traffic for your niche. Stop wasting money on ads. Instead, buy this domain to gain a long-term marketing asset. If you can’t afford to buy then you can rent the domain.
We are Internet Investors, Developers, and Franchisers – operating a content network of several thousand sites while federating 100+ eCommerce and SaaS startups. With our proprietary “inverted incubation” model, we leverage a portfolio of $100M in valued domains to impact online trends, traffic, and transactions. We use robotic process automation, machine learning, and other proprietary approaches to power our content network. Contact us to learn how we can help you with your online marketing and/or site maintenance.