Make an appointment

Book an Appointment


Safety-related changes to daptomycin and ertapenem annotations

On October 5 and November 16, 2007, the United States Food and Drug Administration (FDA) approved changes to the annotation for daptomycin for injection (Cubicin, Cubist Pharmaceuticals) and ertapenem sodium for injection (Invanz, Merck & Co, Inc) affecting the safety of antibiotics. There is new information regarding the possibility of developing diarrhea associated with Clostridium difficile during treatment with these antibacterial drugs.

Like most antibiotics, daptomycin and ertapenem can affect the normal intestinal microflora, causing excessive growth of C. difficile and the subsequent release of toxins A and B, contributing to the development of diarrhea associated with antibiotics (DAA). This condition can vary in severity, from mild diarrhea to severe fatal colitis.

Because the strains producing toxins C. difficile may be resistant to antimicrobial treatment, taking into account the cases of C. diarrhea associated with difficile is associated with mortality increased and may require a colectomy.

The FDA recommends that all patients with symptoms of diarrhea develop antibiotic-associated diarrhea after taking antibiotics. A thorough study of the medical history data is necessary in relation to the risk of AMA cases with late onset of the disease. Therefore, there are case reports of C. diarrhea associated with difficult difficulties occurring more than 2 months after the end of antimicrobial treatment.

The FDA notes that in patients with suspected or established AAD, it may be necessary to discontinue the current antibiotic therapy prescribed for the primary infection. The necessary measures are also adequate rehydration and maintenance of the electrolyte balance, the introduction of protein solutions, antibiotic therapy for the treatment of C. diarrhea associated with difficult and observation of the surgeons.

Daptomycin is used to treat complicated skin and soft tissue infections caused by susceptible strains of gram-positive microorganisms and to treat bacteremia caused by Staphylococcus aureus.

Ertapenem is indicated for the treatment of complicated intra-abdominal infections, complicated skin and soft tissue infections, community-acquired pneumonia, complicated urinary tract infections and infections of the pelvic organs. The drug can also be used to prevent infections in the surgical area after colorectal surgery.

Leave a comment