Drugs Xagena
Annals of Internal Medicine published an article reporting three patients who experienced serious liver toxicity following administration of Ketek ( Telithromycin ).
These cases have also been reported to FDA ( Food and Drug Administration ) MedWatch.
Telithromycin is an antibiotic of the ketolide class.
It was the first antibiotic of this class to be approved by the FDA in April, 2004 for the treatment of respiratory infections in adults caused by several types of susceptible microorganisms including Streptococcus pneumoniae and Haemophilus influenzae.
The FDA is continuing to evaluate the issue of liver problems in association with use of Telithromycin in order to determine if labeling changes or other actions are warranted.
As a part of this, FDA is continuing to work to understand better the frequency of liver-related adverse events reported for approved antibiotics, including Telithromycin.
FDA provides the following recommendations to healthcare providers and patients:
- Healthcare providers should monitor patients taking Telithromycin for signs or symptoms of liver problems. Telithromycin should be stopped in patients who develop signs or symptoms of liver problems.
- Patients who have been prescribed Telithromycin and are not experiencing side effects such as jaundice should continue taking their medicine as prescribed unless otherwise directed by their healthcare provider.
- Patients who notice any yellowing of their eyes or skin or other problems like blurry vision should contact their healthcare provider immediately.
As with all antibiotics, Telithromycin should only be used for infections caused by a susceptible microorganism.
Telithromycin is not effective in treating viral infections, so a patient with a viral infection should not receive Telithromycin since they would be exposed to the risk of side effects without any benefit.
Researchers at the Carolinas Medical Center. Charlotte ( New Carolina ), reported three serious adverse events following administration of Telithromycin.
All three patients developed jaundice and abnormal liver function.
One patient recovered, one required a transplant, and one died.
When the livers of the latter two patients were examined in the laboratory, they showed massive tissue death. These two patients had reported some alcohol use.
All three patients had previously been healthy and were not using other prescription drugs.
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Data from Telithromycins prescribing information state that abnormal results on liver function tests ( alanine aminotransferase levels >3 times the upper limit of normal ) occurred in 1.6% of patients receiving Telithromycin and 1.7% of those receiving the comparator drug and that reversible hepatitis, with or without jaundice, occurred in 0.07% of patients receiving Telithromycin.
The prescribing information for Telithromycin advises caution in patients with a history of hepatitis or jaundice associated with this drug.
Phase III data provided by Sanofi-Aventis described 7 cases of hepatitis or hepatocellular damage in patients taking Telithromycin.
Alcohol use, baseline elevations in aminotransferase levels, and hepatitis B virus infection were confounders in 4 of the cases.
Sanofi-Aventis also reported that 3 cases in a large study comparing Telithromycin with AmoxicillinClavulanate met safety end points for possible substantial drug-related hepatic injury.
Two of these cases were determined to have a compatible temporal relationship between the hepatic adverse event and Telithromycin exposure and the third was determined to involve medical complications, but an effect of the drug could not be discounted.
Postmarketing surveillance has also produced reports of infrequent hepatocellular or cholestatic hepatitis with and without jaundice.
The FDAs AERS ( Adverse Event Reporting System ) describes 10 postmarketing cases of hepatic adverse events associated with Telithromycin use.
Eight of these cases involve a wide range of additional agents taken concomitantly with Telithromycin.
Severity of reactions ranged from serious to fatal ( 2 patients died ) and involved cholestatic hepatitis, abnormal aminotransferase levels, increased bilirubin levels, liver disorder, cholestatic jaundice, and hepatocellular damage.
Duration of Telithromycin use ranged from 1 to 30 days, and patient ages ranged from 35 to 85 years.
Only 2 cases were described with Telithromycin in the absence of other agents; both involved increased aminotransferase levels and required hospitalization, but neither resulted in death.
Source:
1) Fda, 2006
2) Annals of Internal Medicine, 2006
XagenaMedicine_2006
