Defective Drug News

Ketek to Get a Boxed Warning of Heightened Risks

While the popular antibiotic Ketek has been under scrutiny for nearly a year after reports of serious adverse events were linked to the drug, the U.S. Food and Drug Administration has just recently issued a stronger warning label indicating additional Ketek side effects.

The new boxed label advises patients with myasthenia gravis—an autoimmune disease that may lead to potentially fatal muscle weakness—to avoid taking Ketek as it may severely worsen their condition. The label also warns doctors and patients of the serious adverse events associated with the use of Ketek including liver damage, loss of consciousness, vision problems, and more.

Lastly, the new stronger label restricts Ketek from being prescribed to treat bronchitis and sinusitis—although the drug was originally approved for such uses. Ketek may still be used for the treatment of mild to moderate pneumonia.

Reports of Ketek Side Effects

In January 2006, concerns over Ketek side effects were raised after a report showed that three hospital patients suffered extreme liver damage after taking the antibiotic. Since it’s approval in 2004, Ketek has been linked to hundreds of cases of liver damage, at least a dozen cases of liver failure, and nine deaths.

Adverse events linked to Ketek include:

  • Liver injury
  • Colon inflammation
  • Cardiovascular irregularities
  • Vision problems
  • Loss of consciousness

Harmed by Ketek? Please contact us today to speak with a qualified products liability attorney about your legal rights and options.

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