Sanofi, Health Canada warn about use of Ketek.Sanofi-Aventis Canada and Health Canada are warning patients and physicians not to use the antibiotic Ketek to treat bronchitis, sinusitis sinusitis Inflammation of the sinuses. Acute sinusitis, usually due to infections such as the common cold, causes localized pain and tenderness, nasal obstruction and discharge, and malaise. , tonsillitis tonsillitis Inflammatory infection of the tonsils, usually with hemolytic streptococci (see streptococcus) or viruses. The symptoms are sore throat, trouble in swallowing, fever, and enlarged lymph nodes on the neck. or pharyngitis due to risks of liver damage. Ketek can still be used to treat community-acquired pneumonia (CAP). Acute hepatic failure and severe liver injury, in some cases fatal, have been reported in patients treated with Ketek. These hepatic reactions included fulminant ful·mi·nant adj. Occurring suddenly, rapidly, and with great severity or intensity, usually of pain. ful hepatitis and hepatic necrosis leading to liver transplant, and were observed during or immediately after treatment. In some of these cases, liver injury progressed rapidly and occurred after administration of a few doses of Ketek. Earlier this year, Sanofi-Aventis issued a similar "Dear Healthcare Professional" letter to notify clinicians in the U.S. about updated warnings and prescribing information regarding Ketek (telithromycin) tablets. The prescribing information was revised to remove the indications for the treatment of acute exacerbation of chronic bronchitis (AECB AECB Acute exacerbation of chronic bronchitis. See Chronic bronchitis. ) and acute bacterial sinusitis (ABS) from the labeling, and to add a boxed warning and contraindication contraindication /con·tra·in·di·ca·tion/ (-in?di-ka´shun) any condition which renders a particular line of treatment improper or undesirable. con·tra·in·di·ca·tion n. noting that "exacerbations of myasthenia gravis myasthenia gravis (mīəsthē`nēə grä`vĭs), chronic disorder of the muscles characterized by weakness and a tendency to tire easily. have been reported in patients and sometimes occurred within a few hours of the first dose of telithromycin. Reports have included fatal and life-threatening acute respiratory failure with a rapid onset and progression." These revisions followed "discussions with FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. regarding its decision to follow recommendations of a December 2006 Advisory Committee that the balance of the benefits and risks no longer support continued marketing of Ketek for these two indications. It is important to note that Ketek continues to be indicated only for the treatment of community-acquired pneumonia (CAP) of mild to moderate severity due to Streptococcus pneumoniae, (including multi-drug resistant isolates [MDRSP*]), Haemophilus influenzae, Moraxella catarrhalis, Chlamydophila pneumoniae, or Mycoplasma pneumoniae, for patients 18 years old and older." Safety information regarding visual disturbances and loss of consciousness, previously in the precautions section, was added to the warnings section. |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion