New Antibiotic Causes Liver Damage and Death

The antibiotic drug Ketek is the thought to be the cause of several cases of severe liver failure including several deaths. The drug is thought to be the cause because the deaths could not be attributed to any other factor. Think what you may of the FDA, but for all of the unknown good they do it only takes one OOPS like people dying from a drug they approved to bring large amounts of public criticism down on their collective heads. Not that it is undeserved as the Vioxx fiasco proved or the so-called morning after pill brought into question the political neutrality of the FDA. In this wired world, we all know just what is going on at the FDA. It is no different than what goes on in any other department of the government. So with that as a backdrop, you need to know how to stay away from antibiotics in the first place.

There are several natural antibiotics readily available to you at Tri-Valley Health Foods. They are Goldenseal, Grapefruit Seed Extract (GSE), Oregano Oil, Colloidal Silver, Olive Leaf Extract and Xylitol. Goldenseal is probably the most widely known of all of the antibiotic herbs. The active ingredient beribine has mild antibiotic properties. It is usually found in combination with other herbs like echinacea. The active ingredient of Grapefruit seed extract is called citricidal. It has been tested against and found to kill hundreds of types of bacteria. Oregano Oil is a fatty based substance that has only been commercially available for a few years. It has fast become one of my best selling herbal products because it is not only an antibiotic, but it is effective against fungi and viruses as well. Colloidal Silver is an ancient remedy. It supposedly can be traced back to Greece during the Helenistic age. Whereever it was discovered, silver does have some antibiotic properties. It has fallen out of favor in the last few years as better products have emerged on the scene. Olive leaf can also trace it heritage back to the Greeks. The active chemical in olive leaf is called oleuropein. Olive leaf has very strong antiviral properties. Lastly the sugar alcohol Xylitol has some very surprising antibiotic properties. Discovered in WWII in Finland as a sugar substitute, the Finnish noticed that their children had fewer dental cavities using Xylitol than when they were using sugar. Testing hs shown that xylitol kills the bacteria that causes periodontal disease. It is also useful as a nasal rinse for sinusitis. These are all very useful and less toxic ways to kill bacteria instead of using new unproven antibiotics.

I posted the entire article about Ketek below for you to read.

Thanks for spending a art of your day here with me,

James


WASHINGTON (June 29) - The label of a novel antibiotic will be updated to reflect reports of severe liver problems, including several deaths, associated with its use, the drug's maker and health officials said Thursday.
Sanofi-Aventis' Ketek will carry a bold-type warning about the rare reports of liver failure and severe injury, some of them fatal, in patients treated with the drug. The company also is providing additional information to patients and doctors.
The Food and Drug Administration approved Ketek in 2004. The drug is used to treat respiratory tract infections, bronchitis, sinusitis and community-acquired pneumonia. Both the FDA and Sanofi-Aventis believe the drug's benefits still outweigh its risks.
Through April, the FDA has received reports of 12 cases of acute liver failure, including four deaths, among people treated with Ketek. A fifth required a liver transplant.
"In certain of these cases, it appears there are no other likely causes of liver injury, so it does appear they were linked to the use of the drug," said Dr. John Jenkins, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research.
The FDA will continue to monitor the safety of Ketek and take further action if necessary, said a second agency official, Dr. Gerald Dal Pan of the Office of Epidemiology and Surveillance in the drug center.
There have been two further cases of acute liver failure reported since April, though details were not immediately available, Dal Pan said.
The FDA also knows of 23 other cases where patients had serious liver injuries after receiving the antibiotic, which also is called telithromycin.
The rate of reported liver problems associated with the drug is 23 per 10 million prescriptions filled, according to the FDA. In a previously disclosed internal memo, the FDA said the rate appeared higher in comparison with similar antibiotics.
But a study published in January that detailed several of the liver cases associated with the drug may have stimulated the reporting of further problems. That can skew perceptions of the risk of Ketek compared with older but similar antibiotics.
"At this point we cannot conclude the risk is higher than with other antibiotics used to treat these conditions," Dal Pan said.
Dr. Bruce Lavin, vice president of internal medicine for Sanofi-Aventis, said Ketek remains an option needed by doctors when they treat people who are infected with bacteria that have developed resistance to other antibiotics.
The label change comes as the Senate Finance Committee investigates allegations of fraud connected with trials of Ketek, as well as how the FDA has handled safety issues associated with the drug.
"There are questions about whether this drug should stay on the market, and there's great legitimacy to those questions. Ketek is another example where the FDA accommodated a drug maker and turned a blind eye to serious safety concerns," Sen. Charles Grassley, R-Iowa, the committee's chairman, said in a statement.
The updated label for Ketek warns doctors and patients to watch for signs of hepatitis such as fatigue, malaise, anorexia, jaundice and nausea. Patients with signs or symptoms of hepatitis should stop treatment with Ketek immediately and seek a medical evaluation, including liver functions tests, according to the label.
The label was updated to warn of cases of death and life-threatening acute respiratory failure seen in Ketek-treated patients with myasthenia gravis, an autoimmune disorder marked by muscle weakness and fatigue. The FDA knows of three such deaths. Patients with the disorder should not be given Ketek unless other options aren't available, the company said.
This month, Sanofi-Aventis stopped enrolling children in trials of the drug. The company said it had not identified any safety reason that would merit the "pause," but that it wanted to confirm the trial conformed with FDA guidelines.
U.S. sales of Ketek were an estimated $50 million in the first half of 2006, the company said.