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I’ve posted about Ketek several times now and today it is announced that Sanofi has agreed to change the labeling of the drug.

Technology News: Health: Antibiotic Label Will Carry Liver Warning

The warning is in regard to the liver problems and now includes that the drug should not be taken along with any of the statins, which are very common drug for reducing cholesterol. I’ve posted several times about Ketek and have been somewhat pessimistic about it. I guess time will tell. I should note that the side effect is pretty rare; 23 in 10 miilion prescriptions on par with other antibiotics. However, it least adding the warning alerts doctors (and patients who bother to read the package insert or prescribing information) to the potential problems. Also it is approved for use in sinusitis, bronchitis and pneumonia including cases where the bacteria may be resistant.

Here’s quote from the following article: Sanofi adds new liver warning to antibiotic label | Reuters.com

The new, bold-faced warning on Ketek’s label advises doctors and patients to watch for signs of liver problems and stop taking Ketek if they appear. Symptoms can include fatigue, malaise, loss of appetite, nausea, yellow skin and dark urine.

I should also mention that this is a new class of antibiotics called ketolides that certainly hold promise as bacteria become more resistant to the commonly used antibiotics.

Here is the warning on the front page of the Ketek.com website.

KETEK® is contraindicated in patients taking cisapride or pimozide and in patients with a history of hypersensitivity to telithromycin or any macrolide antibiotic.
Exacerbations of myasthenia gravis have been reported in patients with myasthenia gravis treated with KETEK®. KETEK® is not recommended in patients with myasthenia gravis.
KETEK® has the potential to prolong the QTc interval of the electrocardiogram in some patients. QTc prolongation may lead to an increased risk for ventricular arrhythmias, including torsades de pointes. Thus, KETEK® should be avoided in patients with congenital prolongation of the QTc interval, and in patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (eg, quinidine and procainamide) or Class III (eg, dofetilide) antiarrhythmic agents.
KETEK® may cause visual disturbances particularly in slowing the ability to accommodate and the ability to release accommodation. Visual disturbances included blurred vision, difficulty focusing, and diplopia.
There have been post marketing adverse event reports of syncope. Patients should be cautioned about the potential effects of visual disturbance and syncope on driving or engaging in potentially hazardous activities.
Hepatic dysfunction, including increased liver enzymes and hepatitis, with or without jaundice, has been reported with the use of KETEK®. Caution should be used in patients with a previous history of hepatitis/ jaundice associated with the use of KETEK®.
Use of simvastatin, lovastatin, or atorvastatin concomitantly with KETEK® should be avoided. If KETEK® is prescribed, therapy with simvastatin, lovastatin, or atorvastatin should be suspended during the course of treatment. Concomitant treatment of KETEK® with rifampin, a CYP 3A4 inducer, should be avoided.
Most adverse events were mild to moderate and included diarrhea, nausea, headache, dizziness, and vomiting.
*KETEK® is indicated for 5-day treatment in:
Acute bacterial exacerbation of chronic bronchitis (AECB) due to Streptococcus pneumoniae, Haemophilus influenzae,
or Moraxella catarrhalis

Acute bacterial sinusitis due to S pneumoniae, H influenzae, M catarrhalis, and Staphylococcus aureus

7- to 10-day treatment in:
Mild to moderate community-acquired pneumonia due to S pneumoniae, multi-drug resistant S pneumoniae, H influenzae, M catarrhalis, Chlamydophila pneumoniae, or Mycoplasma pneumoniae

Other sources:

KETEK® - Treatment for the Following Respiratory Tract Infections…
Yahoo! News Search Results for ketek label warn
ketek warn label - Google News

Blog Sources:

Google Blog Search: ketek sanofi label
ketek sanofi label - Ask.com Search
IceRocket Blog Search: ketek warn label

Technorati Tags: antibiotics, drug safety, FDA, Ketek, telithromycin

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