CUF REPORT ON ROCEPHIN

The Italian medicines commission, the CUF, has completed its review of the documentation regarding suspected cases of adverse reactions to Hoffmann-La Roche's antibiotic Rocephin (ceftriaxone), with a favorable conclusion for the company.

The CUF appointed a clinical committee to look into reports of adverse reactions in patients receiving the drug, including several deaths, in order to see if they could be attributed to the antibiotic. A review of the hospital files of these patients revealed adverse effects of varying type and severity (including urticaria, nausea, vomiting, headache, hyperpyrexia, dyspnea, paresthesia and anaphylactic shock). The committee concluded that some of these were definitely not attributable to the drug, while others could be considered as possible side effects of any antibiotic and are, in any case, mentioned in the relevant data sheets and package inserts.

"On the basis of the above findings and the favorable chemical and toxicological results supplied by ISS the National Health Institute..Ed. , the CUF has confirmed the safety and tolerability of the preparation Rocephin, which are fully comparable with those of other injectable antibiotics, particularly other third-generation cephalosporins," said the agency. It also stressed that the use of injectable antibiotics should be confined to serious infections such as septicemia, pneumonia and meningitis, and to treat infections in immunocompromised patients.