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 1994. Since the first review of its safety profile in 1995, the patient database has increased substantially. This new safety analysis includes data from 46 clinical trials in hospitalized patients with serious bacterial infections. The additional data comprise patients with lower respiratory tract and intra-abdominal infections, septicaemia and meningitis, and cancer patients with febrile neutropenia, and represents a group of more severely ill patients 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 1g or 500 mg every 8 h. Meropenem-related adverse events most frequently reported were diarrhoea (2.3%), rash (1.4%), nausea/vomiting (1.4%) and injection site inflammation (1.1%). The most commonly reported meropenem-related laboratory adverse events were thrombocytosis (1.6%) and increased hepatic enzymes (1.5-4.3%). In meropenem-treated patients with meningitis, the incidence of seizures was low and none were drug related. In patients with infections other than meningitis, the incidence of 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 the comparator agents. Withdrawals and deaths were similarly infrequent in the meropenem, cephalosporin and imipenem-cilastatin groups. Increased doses of meropenem were not associated with an increased incidence of adverse events. Meropenem was well tolerated in all patients, including children and patients with neutropenia. This new analysis supports the previous findings that meropenem has a favourable and acceptable safety profile.