Could FDA End Deadly Antibiotic Drug Trials?

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June 24, 2006 | 5,997 views

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.

  • Vioxx: The king of withdrawn drugs and well documented in previous chapters for causing 60,000 fatal heart attacks and strokes, and as many as 160,000 heart attacks and strokes, all by itself.

  • Bextra: Similar drug to Vioxx, withdrawn for similar reasons.

  • Rezulin: Given fast-track approval by the Food and Drug Administration, Rezulin was linked to 63 confirmed deaths and probably hundreds more. "We have real trouble," an FDA physician wrote in 1997, just a few months after Rezulin's approval. The drug wasn't taken off the market until 2000.

  • Baycol  (made by Bayer AG): A cholesterol-lowering drug taken by 700,000 Americans was pulled off the market in August 2000. It had been linked to 31 U.S. deaths. At least nine more fatalities abroad are known.

  • Lotronex: Against concerns of one of its own officers, the FDA approved Lotronex in February 2000. By the time it was withdrawn nine months later, the FDA had received reports of 93 hospitalizations, multiple emergency bowel surgeries, and five deaths.

  • Propulsid: A top-selling drug for many years, this drug was linked to hundreds of cases of heart arrhythmias and over 100 deaths.

  • Redux: Taken by millions of people for weight loss after its approval in April 1996, Redux was soon linked to heart valve damage and a disabling, often lethal, pulmonary disorder. Taken off the market in September 1997.

  • Pondimin: A component of Fen-Phen, the diet fad drug. Approved in 1973, Pondimin's link to heart valve damage and a lethal pulmonary disorder wasn't recognized until shortly before its withdrawal in 1997.

  • Duract: This painkiller was taken off the market when it was linked to severe, sometimes fatal, liver failure.

  • Seldane: America's, and the world's, top-selling antihistamine for a decade, it took the FDA five years to recognize that Seldane was causing cardiac arrhythmias, blackouts, hospitalizations, and deaths, and another eight years to take it off the market.

  • Hismanal: Approved in 1988 and soon known to cause cardiac arrhythmias, the drug was finally taken off the market in 1999.

  • Posicor: Used to treat hypertension, the drug was linked to life-threatening drug interactions and more than 100 deaths.

  • Raxar: Linked to cardiac toxicities and deaths.

  • Cylert: FDA received 13 reports of pemoline-associated hepatic failure leading to liver transplantation or death, representing an incidence rate 10 to 25 times greater than that of the general population.

  • Palladone: Withdrawn due to a high risk of accidental overdose when administered with alcohol.

  • Tysabri: Was expected to become the world's leading treatment for MS, but was pulled from the market after a patient died from a rare central nervous system infection.

  • [+]Sources and References [-]Sources and References