PARIS (AFX) – Sanofi-Aventis said today that the European Medicines Agency (EMEA) has updated its indications for use of the group’s Ketek antibiotic, prohibiting its use for patients with a rare auto-immune disease and giving a ‘strengthened warning’ of other side effects for all patients.
In a statement, the group said EMEA’s Committee for Medicinal Products for Human use (CHMP) concluded that the effectiveness of Ketek has been confirmed in its approved indications in Europe.
Last month, the US Food and Drug Administration (FDA) restricted the prescription of Ketek to the treatment of pneumonia and no longer for less serious illnesses after it was linked to rare reports of severe liver problems, leading to several deaths.
In its statement today, Sanofi-Aventis said the strengthened EMEA warning notes the occurrence of ‘temporary visual disturbances and transient loss of consciousness… for which a bedtime intake should be considered to reduce the impact of these side effects.’
The group added that ‘severe problems with the liver have rarely been reported with Ketek but they do not occur more frequently than with other relevant antibiotic medicines.’
It said however that the medicine is now prohibited by the EMEA for use with patients with myasthenia gravis, a rare autoimmune disease.
Sanofi-Aventis said it ‘commits to undertake risks minimization measures by providing updated information to healthcare professionals and myasthenia gravis patient associations.’
It said Ketek is currently marketed in over 50 countries and that over 30 mln courses of treatment with the drug have been prescribed worldwide to date.
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