FDA warns of new risks to babies with Roche drug

WASHINGTON Thu Jul 5, 2007 5:42pm EDT

WASHINGTON (Reuters) - 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.

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