Ketek Gets Limits On Use, New Warning

[OhioChick]

Antibiotic Linked To Liver Problems

POSTED: 1:45 pm EST February 12, 2007

WASHINGTON -- The government on Monday restricted use of an antibiotic linked to rare reports of severe liver problems, including several deaths, saying the drug now should be used only to treat pneumonia but not less serious bacterial infections like bronchitis and sinusitis.

The Food and Drug Administration said the antibiotic, Ketek, would remain on the market but that its label will bear a new, stern warning. The agency said it and manufacturer Sanofi-Aventis SA also created a guide for patients outlining the drug's risks and its safe use.

The changes are in line with the December recommendations of a panel of FDA expert advisers that the agency modify the label of the drug, also called telithromycin. In 17-2 votes, the outside advisers said the drug's benefits don't outweigh its risks in treating bronchitis and sinusitis, which are less serious infections than pneumonia and often spontaneously resolve on their own.

"The agency has determined that the balance of benefits and risks no longer support approval of the drug for these indications," the FDA said in a statement.

http://www.newsnet5.com/health/10990258/detail.html

[SCRUBDASHRUB]

1. Scary; I recall being prescribed this not too long ago for an

infection (sinus, I believe). Thanks for posting.