Ketek

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

Wednesday, February 14, 2007 by: David Gutierrez, staff writer
Tags: black box warning, ketek, the FDA

eTrust Pro Certified

Most Viewed Articles
Popular on Facebook
The five biggest lies about Ebola being pushed by government and mass media
Why does the CDC own a patent on Ebola 'invention?'
White House admits staging fake vaccination operation to gather DNA from the public
Ultraviolet light robot kills Ebola in two minutes; why doesn't every hospital have one of these?
EXCLUSIVE: Natural News tests flu vaccine for heavy metals, finds 25,000 times higher mercury level than EPA limit for water
Truvia sweetener a powerful pesticide; scientists shocked as fruit flies die in less than a week from eating GMO-derived erythritol
Irrefutable proof we are all being sprayed with poison: 571 tons of toxic lead 'chemtrailed' into America's skies every year
Russia taking McDonald's to court, threatens countrywide shutdown
Oregon man serving prison sentence for collecting rainwater on his own property
The best way to help your body protect itself against Ebola (or any virus or bacteria)
Senator who attacked Doctor Oz over dietary supplements received over $146,000 in campaign contributions from Big Pharma mega-retailer and Monsanto
Global warming data FAKED by government to fit climate change fictions
Healthy 12-year-old girl dies shortly after receiving HPV vaccine
Ebola outbreak may already be uncontrollable; Monsanto invests in Ebola treatment drug company as pandemic spreads
HOAX confirmed: Michelle Obama 'GMOs for children' campaign a parody of modern agricultural politics
Ben & Jerry's switches to non-GMO, Fair Trade ice cream ingredients
W.H.O. contradicts CDC, admits Ebola can spread via coughing, sneezing and by touching contaminated surfaces
BREAKING: CDC whistleblower confesses to MMR vaccine research fraud in historic public statement
Delicious
(NaturalNews) 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.

"FDA has determined that the balance of benefits and risks for Ketek do not support continued approval of Ketek for these generally nonserious and often self-limited illnesses," said Dr. John Jenkins, director of the agency's Office of New Drugs.

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.

Even before the new rules, Ketek already carried a bold warning about possible liver damage. Stronger warnings have now been added about other possible side effects, including blurred vision and loss of consciousness.

Sen. Charles Grassley of Iowa, who headed the Senate investigation and has been highly critical of the FDA's approval of the drug, expressed satisfaction with the new rules. "When the spotlight was turned on the questionable way in which Ketek got approved ... the FDA was held accountable," he said.

But not everyone is convinced that the new rules go far enough. "A black box warning is the FDA's way of justifying the continued sale of dangerous drugs that should probably be pulled from the marketplace," said Mike Adams, author of "Natural Health Solutions."

"Every time the FDA can no longer refute the evidence that a particular drug is extremely dangerous to the public, it resorts to using the black box warning to deflect attention from the fact that the drug should probably be banned. It's a tactical ploy used to maximize Big Pharma profits, which seems to be the FDA's primary mission now."

###

Join over four million monthly readers. Your privacy is protected. Unsubscribe at any time.
comments powered by Disqus
Take Action: Support NaturalNews.com by linking back to this article from your website

Permalink to this article:

Embed article link: (copy HTML code below):

Reprinting this article:
Non-commercial use OK, cite NaturalNews.com with clickable link.

Follow Natural News on Facebook, Twitter, Google Plus, and Pinterest

Colloidal Silver

Advertise with NaturalNews...

Support NaturalNews Sponsors:

Advertise with NaturalNews...

GET SHOW DETAILS
+ a FREE GIFT

Sign up for the FREE Natural News Email Newsletter

Receive breaking news on GMOs, vaccines, fluoride, radiation protection, natural cures, food safety alerts and interviews with the world's top experts on natural health and more.

Join over 7 million monthly readers of NaturalNews.com, the internet's No. 1 natural health news site. (Source: Alexa.com)

Your email address *

Please enter the code you see above*

No Thanks

Already have it and love it!

Natural News supports and helps fund these organizations:

* Required. Once you click submit, we will send you an email asking you to confirm your free registration. Your privacy is assured and your information is kept confidential. You may unsubscribe at anytime.