Safety profile of meropenem: a review of nearly 5,000 patients treated with meropenem

Meropenem is a parenteral carbapenem that has been used clinically since 19 94. Since the first review of its safety profile in 1995, the patient datab ase has increased substantially. This new safety analysis includes data fro m 46 clinical trials in hospitalized patients with serious bacterial infect ions. The additional data comprise patients with lower respiratory tract an d intra-abdominal infections, septicaemia and meningitis, and cancer patien ts with febrile neutropenia, and represents a group of more severely ill pa tients compared with the earlier review. In total, 4872 patients with 5026 meropenem treatment exposures were compared with 4642 patients treated with comparator agents (4752 exposures). Meropenem was administered most often by intravenous injection at 1 g or 500 mg every 8 h. Meropenem-related adve rse events most frequently reported were diarrhoea (2.3%), rash (1.4%), nau sea/vomiting (1.4%) and injection site inflammation (1.1%). The most common ly reported meropenem-related laboratory adverse events were thrombocytosis (1.6%) and increased hepatic enzymes (1.5-4.3%). In meropenem-treated pati ents with meningitis, the incidence of seizures was low and none mere drug related. In patients with infections other than meningitis, the incidence o f seizures considered by the investigators to be related to meropenem was 0 .08%. In general, the safety profile of meropenem was similar to that of th e comparator agents. Withdrawals and deaths were similarly infrequent in th e meropenem, cephalosporin and imipenem-cilastatin groups. Increased doses of meropenem mere not associated with an increased incidence of adverse eve nts. Meropenem mas well tolerated in all patients, including children and p atients with neutropenia. This new analysis supports the previous findings that meropenem has a favourable and acceptable safety profile.