FDA warns of new risks to babies with Roche drug

U.S. regulators on Thursday warned doctors of new risks to newborn babies, including death, associated with combining an antibiotic made by Swiss drugmaker Roche Holding AG with certain other treatments.

The U.S. Food and Drug Administration said that the injection, called Rocephin, 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.

The FDA reported the new warning on the “MedWatch” section of its Web site on Thursday. Also posted is a letter to doctors dated June 2007 describing the drug’s updated prescribing information.

A spokesman for Roche USA was not available for comment.

The drug, also known as ceftriaxone sodium, is approved to treat lower respiratory infections, urinary tract infections, gonorrhea and other infections.

Print Version
Tell-a-Friend comments powered by Disqus

RELATED ARTICLES:

New biomarkers may influence drug design and alternative treatments of cancer, study shows   UGA ecologist finds another cause of antibiotic resistance   New drug for neuroblastoma shows promise in phase I study   Baclofen shows promise in patients with alcohol-induced liver disease   UTSW researchers identify a therapeutic strategy that may treat a childhood neurological disorder   Findings point to an ‘off switch’ for drug resistance in cancer   Siblings of children with autism can show signs at 18 months   Stopping statins may benefit terminally ill patients   Study finds hazardous flame retardants in preschools   Cholesterol drug users may use pills as a license to overeat   Pfizer lung cancer drug beats chemo for previously untreated patients   Mass. General study identifies path to safer drugs for heart disease, cancer