Astellas to discontinue Ketek antibiotics

Astellas is to discontinue the production of Ketek antibiotic tablets, it was announced today – a. decision which follows recent FDA investigations into the drug.

The pharmaceutical will no longer be involved in its alliance with fellow manufacturer Sanofi-aventis and they will discontinue production from September 30th this year. Known as the first ketolide, the drug was produced to treat community-acquired respiratory tract infections. These included Streptococcus pneumoniae bacteria that have so far proved resistant to other drugs.

Astellas states that the drug was launched in December 2003 and was marketed for the “treatment of pharyngitis/laryngitis, tonsillitis, acute bronchitis, pneumonia and secondary infections of chronic respiratory disease”.

Earlier this year, the Annals of Internal Medicine published a report suggesting that patients had suffered “severe liver toxicity” following the Ketek therapy. The FDA reports that it is to continue examining liver problems as a result of the findings, though it cannot be sure of the frequency of adverse symptoms following the report.

It states that it is to carry on its endeavours to understand the frequency of incidents where Ketek causes liver dysfunction and has provided a list of recommendations for patients and healthcare providers in the meantime.

Of the three patients studied in the trial, one recovered, one was given a transplant and the other died. It is thought that two of the patients had said they drank alcohol while and that liver tissue death was also observed in two of the patients’ livers.

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