Roche warns of antibiotic baby risk

Roche has issued a letter to physicians warning of the potential risk to infants relating to its injectable antibiotic Rocephin (ceftriaxone) following reports of deaths of babies both premature and full-term administered with calcium within 48 hours of receiving the drug.

The drug is an antibiotic of the cephalosporin class and was introduced in 1982, with sales outranking those for all other Roche products worldwide by 1987.

It is used as a treatment for a range of bacterial infections, such as pneumonia, bronchitis, skin infections, meningitis, ear infections and others.

Antibiotics are recommended for use in infants with ear infections by the National Institutes of Health, Bloomberg notes.

“The US Food and Drug Administration (FDA) said that the injection?should not be combined with calcium or calcium-containing products, following reports of an unspecified number of cases of fatal reactions in the lungs and kidneys of newborns,” Reuters reports.

A warning regarding the drug was posted on the website of the FDA yesterday, while doctors have received updating prescribing information for the compound.

At its annual general meeting in February 2006, Roche reported a drop in sales of Rocephin – once its sole billion-selling pharmaceutical product – following its US patent expiry in 2004.