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.
The conclusion of this article appears on NewsTarget.com, the independent natural health news source for consumers. This article, along with other uncensored news on important consumer health topics, can be found at:
Ketek antibiotic to carry black box warning, new use limitations by FDA
http://www.newstarget.com/021604.html
About NewsTarget
Read by over 500,000 unique readers monthly, NewsTarget is a progressive, independent natural health news site that teaches consumers how to improve their health through foods, herbs, exercise and natural therapies. The site also warns consumers about the dangers of processed foods, pharmaceuticals, chemotherapy, environmental toxins and the failure of government regulators like the FDA.