Very soon controversial antibiotic ‘Ketek’ (generic name telithromycin) would come with a ‘black box’ warning when prescribed to treat pneumonia. The U.S. Food and Drug Administration announced this on Monday. Moreover, FDA has announced that from now ‘Ketek’ would not be used to treat health problems like sinusitis and bronchitis.
Ketek was approved by FDA in the year 2004, for the treatment of sinusitis, bronchitis and community-acquired pneumonia and is sold in more than 50 countries and has been used to treat an estimated 28 million patients worldwide. The main purpose behind labeling ketek with a black box is to show its major side effects like liver injury, rare neuromuscular problems and vision disturbances, etc.
Now on this black box warning there would be warning stating that no one with myasthenia gravis, a neuromuscular condition should take ‘Ketek’ since results can be life-threatening. As the following words of John Jenkins, director of the FDA’s Office of New Drugs states:
…it can lead to potentially life-threatening exacerbations of their disease.
This is a good move hurled by FDA since we know that this drug is quite useful for treating patients with mild respiratory infections but at the same time we can not keep a blind eye to the fact that it does have life-threatening side effects too. Therefore, it becomes quite important to know about the negative aspect of this drug before seeking help from it.
Image credit: Kcci
Via: USA Today