The antibiotic drug Ketek, manufactured by Sanofi-Aventis, is being tested to treat ear infections and tonsillitis in close to 4,000 children, ages 6 months to 13 years.
Although the Food and Drug Administration (FDA) approved plans for the trials, in May 2006 an FDA official said -- according to internal memos -- that the trials should be halted because Ketek could be deadly.
The antibiotic, approved for use in adults, appears to be more toxic than other antibiotics. Side effects range from liver failure and blurred vision to loss of consciousness.
Though other antibiotics have been associated with liver failure, the condition seems to be four times as common in Ketek. In the United States, 12 adults taking Ketek have had liver failure, of which four died, and 23 had serious liver injury since the drug was approved two years ago.
In the memos, FDA safety officials said the agency should consider withdrawing Ketek from the market, severely restrict its uses, or add a strong warning about its potentially deadly side effects. A spokesperson for the FDA said the memos were "a ... raw assessment" and a final decision would be made by "experts who have the full benefit of a large section of opinion and scientific fact."
Please understand that I fully appreciate how useful antibiotics can be, and I am very grateful that we have them as a tool that can save lives. However, 95 percent of the time they are absolutely unnecessary.
The use of this Ketek in children for ear infections is one of those cases, and any drug company testing it for that purpose is committing reprehensible criminal malpractice.
Why such strong feelings, you ask?
Antibiotics for ear infections are one of the most common uses of drugs in children -- about 10 million prescriptions are used for 6 million kids every year in the United States.
After more than two decades of clinical practice it is my experience that ear infections in children were one of the easiest conditions to treat and, more importantly, to prevent.
But that is not just my opinion. Many experts have reached this conclusion and found that the majority of ear infections clear up without antibiotics.
If you want to know how you can treat ear infections without drugs please read the links below.
Four thousand children are currently being abused by the makers of Ketek when there is growing evidence that Ketek is unusually toxic. Twelve adult patients in the United States have suffered liver failure, including four who died; 23 others suffered serious liver injury. Other antibiotics cause liver failure, but Ketek seems to do so almost four times as often.
How could this drug even be considered for use in kids?
If you have been reading this newsletter for awhile, you will certainly know the answer to that one -- the desire to increase the bottom line with patent disregard for human health. It's apparently not good enough that they are the most profitable industry on the planet, they just want more, and the system is set up to have the FDA allow them to do this.
My guess is that this drug will eventually be pulled from the market and join the others that have had that distinction since I started this newsletter.
If you thought that pulling drugs off the market is a rare event, you can review the other 16 drugs that have been pulled since I have been publishing the newsletter.