Europe imposes restrictions on Ketek prescribing
pharmafile | April 16, 2007 | News story | Sales and Marketing |Â Â Ketek, safetyÂ
The European Medicines Agency has issued guidance for the four indications of Ketek, the Sanofi-Aventis antibiotic stripped of several indications earlier this year by the FDA following safety fears.
Reports of severe liver injuries in patients taking the drug prompted an EMEA investigation and it has recommended restrictions in three indications: the treatment of bronchitis, sinusitis and tonsillitis/pharyngitis.
It says Ketek (telithromycin), should only be used for infections caused by bacterial strains that are suspected or proven to be resistant to – or cannot be treated with – macrolide or beta-lactam antibiotics. The agency has put no restrictions on the fourth indication, however – Ketek's treatment of community-acquired pneumonia.
It appears a less draconian response than that of the FDA, which in February removed two of the three previously approved indications – acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis – saying that the balance of benefits and risks no longer supported them.
But the EMEA's Committee for Medicinal Products for Human Use (CHMP) has, in fact, mirrored several of the FDA's actions, recommending the contraindication of the use of Ketek in patients with the potentially fatal muscle-weakening disease myasthenia gravisk, and strengthening warnings on side-effects such as loss of consciousness and effects on vision. This follows last year's labeling changes in which the EMEA warned of serious liver reactions and contraindicated Ketek in patients with a previous history of serious liver disorders.
The new precautions in the US and Europe are evidence of regulators' increasing use of post-marketing pharmacovigilance. In the US, Ketek remains on the market for the treatment of mild to moderate, community-acquired pneumonia. But the FDA made Sanofi Aventis develop a patient information guide to be handed out with each subscription, and enforced a change in Zetek's labeling to include a strong warning that the drug should not be contraindicated in patients with myasthenia gravis.
Ketek remains approved and marketed in more than 50 countries.
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