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Ketek antibiotic to carry black box warning, new use limitations by FDA

The FDA has strengthened its warnings on the controversial antibiotic Ketek and banned the drug's use for treatment of sinusitis and bronchitis. The new move follows a yearlong FDA investigation into the drug's side effects. The use of the drug will still be permitted for pneumonia.

The FDA investigation began after a scandal broke out over severe liver complications that led to the deaths of five Ketek patients. The deaths sparked a Senate Finance Committee investigation into whether faulty data and fraud were used in the FDA's approval process for the drug.

Under the FDA's new rules, Ketek will carry a "black box" warning against its use by patients with the neuromuscular disorder myasthenia gravis. The "black box" warning -- so called because of the thick black border used to make it stand out -- is the strongest warning that the FDA can put on a drug. Any stronger concerns about a drug's safety require that it be banned.

Click here to read the original article  (newstarget.com)

Lawsuits of Interest

Accutane  (isotretinoin)
Advair  (Fluticasone/salmeterol)
Avandia  (Rosiglitazone)
Bextra  (Valdecoxib)
Celebrex  (Celecoxib)
Chantix  (Varenicline)
Digitek  (Digoxin)