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

Delicious Pin It
(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."

###

Get breaking news alerts on GMOs, fluoride, superfoods, natural cures and more...
Join over four million monthly readers. Email privacy 100% protected. Unsubscribe at any time.


Have comments on this article? Post them here:

comments powered by Disqus

Take Action: Support NaturalNews.com

Email this article to a friend

Permalink to this article:

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

Embed article link: (copy HTML code below):
Most Popular
Today | Week | Month | Year

See all Top Headlines...



GET SHOW DETAILS
+ a FREE GIFT

Now Available at ShopNaturalNews.com

O3 Essentials OraJuvenate™
A powerful, cleansing dental cream for maximum oral/dental health.
New Cancer Solutions
Over 3 hours of content covering today’s best cancer tests, how to kill cancer cells and the best diets and exercise routines.
Freeze-Dried 100% Organic Whole Corn
Our freeze-drying method preserves taste, texture and nutrients better than any other food preservation method ever invented.
Fenix TK35 Flashlight
Tough, waterproof, extremely bright and it’s touted to throw an 800+ lumen beam more than 1,000 feet into the night.
Inca Treasure Smoothie Pack
This pack of our four most popular superfoods from South America is the perfect combo pack for smoothie lovers.
Pink Himalayan Salt
This salt delivers significant levels of magnesium, zinc and selenium, with trace levels of dozens of other elements.
Pinhole Glasses - Aviator Style
Pinhole glasses are becoming famous for helping people improve their vision without the risks of laser surgery.
Oxy-Rich Facial Serum
O3 Essentials Jojoba Oxy-Rich Facial Serum is cellular nourishment for your skin. Helps smooth fine lines while enhancing tissue elasticity.
Freeze-Dried 100% Blackberry Halves
Our freeze-dried blackberry halves are grown in Serbia under strict organic standards.

Also on NaturalNews:

Health Ranger Videos
Activist music
CounterThink Cartoons
Food documentaries
FREE Special Reports
Podcasts
Colloidal Silver

Advertise with NaturalNews...

Support NaturalNews Sponsors:

Advertise with NaturalNews...

Most Popular Stories

Flu shot kills 19-year-old, but vaccine industry still has total immunity against lawsuits
Here's a nutty fact: Eating more tree nuts lowers the risk of all-cause death by up to 20 percent
Six important facts you're not being told about lost Malaysia Airlines Flight 370
Malaysia Airlines Flight 370 now clearly a government cover-up: All evidence contradicts official story
10 other companies that use the same Subway yoga mat chemical in their buns
BLM fracking racket exposed! Armed siege and cattle theft from Bundy ranch really about fracking leases
High-dose vitamin C injections shown to annihilate cancer
U.S. treating meat with ammonia, bleach and antibiotics to kill the '24-hour sickness'
USDA to allow U.S. to be overrun with contaminated chicken from China
Vaccine fraud exposed: Measles and mumps making a huge comeback because vaccines are designed to fail, say Merck virologists
Battle for humanity nearly lost: global food supply deliberately engineered to end life, not nourish it
Diet soda, aspartame linked to premature deaths in women

25 Amazing Facts About Food

This FREE downloadable report unveils a collection of astonishing and little-known facts about the food we eat very day. Click here to read it now...

 

Resveratrol and its Effects on Human Health and Longevity - Myth or Miracle.

Unlock the secrets of cellular health with the "miracle" nutrient Resveratrol Click here to read it now...

 

Nutrition Can Save America

FREE online report shows how we can save America through a nutrition health care revolution. "Eating healthy is patriotic!" Click here to read it now...

The Healing Power of Sunlight and Vitamin D

In this exclusive interview, Dr. Michael Holick reveals fascinating facts on how vitamin D is created and used in the human body to ward off chronic diseases like cancer, osteoporosis, mental disorders and more. Click here to read it now...

Vaccines: Get the Full Story

The International Medical Council on Vaccination has released, exclusively through NaturalNews.com, a groundbreaking document containing the signatures of physicians, brain surgeons and professors, all of which have signed on to a document stating that vaccines pose a significant risk of harm to the health of children. Click here to read it now...

Health Ranger Storable Organics

GMO-free, chemical-free foods and superfoods for long-term storage and preparedness. See selection at www.StorableOrganics.com



Recommended Resources On:

Natural News trends
Health Ranger news
Natural News GMOs
Mike Adams tracker
Natural News photos
Natural News Global
Natural News in focus
Natural News connect
Natural News shocking stories
Natural News radar
GMOs
Quackwatch
Vaccines
Health freedom
Dr. Paul Offit

This site is part of the Natural News Network © 2014 All Rights Reserved. Privacy | Terms All content posted on this site is commentary or opinion and is protected under Free Speech. Truth Publishing International, LTD. is not responsible for content written by contributing authors. The information on this site is provided for educational and entertainment purposes only. It is not intended as a substitute for professional advice of any kind. Truth Publishing assumes no responsibility for the use or misuse of this material. Your use of this website indicates your agreement to these terms and those published here. All trademarks, registered trademarks and servicemarks mentioned on this site are the property of their respective owners.

eTrust Pro Certified Android app on Google Play

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.