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Stronger Warning Ordered For Ketek Antibiotic

A few days ago, the Food and Drug Administration ordered stronger warnings of potentially deadly liver failure with the antibiotic Ketek (telithromycin).

Ketek is approved to treat acute bacterial sinusitis, pneumonia, and chronic bronchitis.

The stronger warning is based on the FDA’s review of Ketek’s postmarketing adverse event reports. Those records show 12 cases of acute liver failure — four of which were fatal; a fifth required a liver transplant. There were also an additional 23 cases of acute liver injury.

Ketek’s new label will advise doctors and patients to watch carefully for signs and symptoms of liver injury while taking Ketek and to discontinue the drug promptly if any signs or symptoms of liver injury are to develop.

When the FDA approved Ketek in April 2004, the drug’s labeling included precautions about liver injury and possible worsening of myasthenia gravis, as with other drugs in its class.

Bob Kraft

I am a Dallas, Texas lawyer who has had the privilege of helping thousands of clients since 1971 in the areas of Personal Injury law and Social Security Disability.

About This Blog

The title of this blog reflects my attitude toward those government agencies and insurance companies that routinely mistreat injured or disabled people. As a Dallas, Texas lawyer, I've spent more than 45 years trying to help those poor folk, and I have been frustrated daily by the actions of the people on the other side of their claims. (Sorry if I offended you...)

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