The FDA announced that the antibiotic Ketek which is used to treat pneumonia must come with a new black box? warning. The warning comes after the medication has been linked through studies to cause substantial liver damage.
The drug has also been limited in the areas it is prescribed for. Ketek is no longer recommended to treat the two milder conditions sinusitis and bronchitis.
According to Dr. John Jenkins director of the Office of New Drugs at the FDA's Center for Drug Evaluation and Research, "The changes are designed to inform health-care providers and patients regarding the safe and effective use of Ketek consistent with advice received from advisory committees in December of last year, the changes are the result of a comprehensive analysis of available data regarding the benefits and risks of Ketek conducted by [FDA] team members."
An article from Forbes.com states, The drug and the related approval process have been dogged by criticism, however. Last June, Sanofi-Aventis agreed to update Ketek's labeling to reflect the possibility of severe liver damage. And last month, a European Medicines Agency panel recommended that Ketek not be given to patients with a history of such liver conditions as hepatitis or jaundice.
On top of all this, the makers Ketek, Sanofi-Aventis, are under investigation by the Senate Finance Committee for cases of fraud discovered during the approval trial as well as another trail filed by the House of Representatives sub committee investigating irregularities in the approval process.
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FDA Calls for “Black Box” on Controversial Antibiotic
By : info@epharmacies.com
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Keywords:
ketek