SANOFI-AVENTIS SAID ON THURSDAY IT HAS ADDED A BOLDED WARNING TO THE LABEL FOR ITS ANTIBIOTIC KETEK, ADVISING DOCTORS AND PATIENTS ABOUT THE POTENTIAL FOR SERIOUS LIVER DAMAGE ASSOCIATED WITH THE DRUG, ACCORDING TO REUTERS. THE FRENCH DRUG MAKER SAID THE U.S. FOOD AND DRUG ADMINISTRATION HAD BEEN ADVISED ABOUT AND AGREED TO THE CHANGES TO THE PRESCRIBING INFORMATION, WHICH INCLUDES REVISED RECOMMENDATIONS FOR THE USE OF KETEK IN PATIENTS WITH MYASTHENIA GRAVIS. KETEK, WHICH WAS APPROVED IN APRIL OF 2004 TO TREAT RESPIRATORY INFECTIONS IN ADULTS, CAME UNDER INTENSE SCRUTINY IN JANUARY AFTER RESEARCHERS REPORTED THAT THREE PATIENTS DEVELOPED SEVERE LIVER DAMAGE AND ONE DIED. EARLIER THIS MONTH, SANOFI-AVENTIS HALTED ENROLLMENT OF CLINICAL TRIALS OF KETEK IN CHILDREN. "BASED ON THE IN-DEPTH REVIEW OF THE CLINICAL TRIAL AND POST-MARKETING DATA, WE CONTINUE TO BELIEVE THAT THE BENEFITS OF KETEK OUTWEIGH THE RISKS WHEN THE DRUG IS USED AS DIRECTED" FOR APPROVED USES, SAID DR. SOL RAJFER, PRESIDENT OF SCIENCE AND MEDICAL AFFAIRS AT SANOFI-AVENTIS U.S. SANOFI SHARES CLOSED UP $2.24 TO $48.17 ON THE NEW YORK STOCK EXCHANGE ON THURSDAY AMID A BROAD MARKET RALLY.
