The Fluoroquinolone Toxicity Research Foundation

 
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Addressed to the Honorable Rush Holt, United States House of Representatives on February 12, 2004:

My name is Gary Pettijohn, residing in Batesville, Indiana. Although I have not personally taken or suffered any adverse reaction to a chemotherapeutic agent, commonly referred to as a fluoroquinolone type drug, I make this statement on behalf of a loved one who cannot be with us today to tell of her plight. My daughter, Kristen Pettijohn, passed away from complications resulting from multiple simultaneous severe adverse reactions to the fluoroquinolone, Avelox. These reactions are documented by the extensive autopsy and toxicology tests performed after her death by the Indiana University Medical hospital in Indianapolis.

Within 8 days I watched in horror as a vibrant, energetic, healthy young lady went from a mild respiratory illness to suffering from severe abdominal pain, hallucinating, incoherent, a skin rash to comatose, liver failure, kidneys failing, skin peeling off in sheets (toxic epidermal necrolysis), and on life support and then ultimately death, a direct result of taking but 3 doses of Avelox for a minor respiratory infection.

The loss of Kristen is not only a tragic loss to her family, fiancée, and friends but to society as well. Kristen was a junior in the Indiana University School of Nursing carrying a straight A average. She was the type of person that put other's interests ahead of her own. She felt nursing was a way for her to contribute to society and the betterment of others. Everyone who got to know or meet Kristen felt there was no doubt this beautiful young lady would have been a significant contributor to society.

Kristen was diagnosed with bronchitis and was prescribed Avelox to clear this mild ailment. She even carefully read the attached warning literature that accompanied the drug and also referenced "Davis's Drug Guide For Nurses", eighth edition, to verify dosage and review potential adverse reactions. What she was about to suffer from the Avelox was not completely mentioned in either the accompanying warning label or Nurse’s text and what adverse reactions that were listed were significantly downplayed to the point there would be only a minor concern in taking this drug.


Knowing what we know now, after extensive research on Avelox and other fluoroquinolones, there is no doubt that anyone in our family, including Kristen, would have ever consented to taking this poison. Based upon the incidences of adverse reactions as well as their severity and life threatening events I conclude this drug should only be used for very chronic verifiable bacterial infections and / or life threatening conditions but never for initial treatment.

Unfortunately, this information was not known at the time that she took the first of 3 doses
of Avelox. Despite immediately discontinuing to take the remaining prescribed Avelox after the very first signs started, she was taken to a hospital emergency ward seeking treatment. No medical personnel, of whom there were several, called in to see her, could diagnose her condition or offer any treatment for her. You see there is no treatment protocol for adverse reactions to Avelox in which medical personnel can follow. So I must ask what good does it to put out warning labels when; (1) you could die from an adverse reaction from the very first dose, and (2) if you did suffer an adverse reaction there is no treatment known or approved to remedy the adverse reactions. Additionally if the medical personnel have no knowledge of such severe adverse reactions how can they possibly participate in a risk/benefit discussion of any value?

I offer the following investigative report published by Knight Rider News on November 4, 2003. This report briefly describes the chronology of events and her severe reactions resulting from the Avelox. I ask on behalf of my late daughter, Kristen, as well as others who are not able to state their claim, to look closely at the "real" facts as to the damage the fluoroquinolones is doing to our society. This family of drugs in which there has already been specific drugs banned for use should all be banned for use or at a minimum reduces the usage to only the most severe verifiable bacterial infections.

Respectfully submitted on the behalf of the late Kristen Pettijohn (Deceased),

Mr. and Mrs. Gary Pettijohn

 

MISUSE OFTEN ENCOURAGED

The drug Kristen Pettijohn took was called Avelox. It's part of a family of antibiotics called fluoroquinolones. Those powerful but risky drugs are intended for patients who are fighting particular bacterial bugs. But they're widely prescribed off-label for less serious illnesses, sometimes even to treat viruses, which can't be killed by antibiotics.

A study this year funded by the National Institutes of Health reviewed 100 emergency room prescriptions for fluoroquinolones and found that only 19 were written for appropriate conditions and only one was given in the correct dose and for the proper duration.

The FDA long has been aware of the possibility that Avelox could be misused. Just before it approved Avelox in 1999, a member of the agency's expert review panel — Robert Danner, a critical care expert at the NIH — offered a warning: "This is exactly the kind of place that you get into trouble. … I am absolutely convinced that the drug will be used differently once it's marketed frequently."

Avelox was approved, however, and marketed hard by Bayer Corp. In 1999 and 2001, the FDA admonished company officials for encouraging unapproved uses.

This past May, Pettijohn, a gregarious 23-year-old nursing student from Batesville, Ind., who recently had gotten engaged, picked up the persistent cold that had been running through her family. "Her version was a little worse than ours," said her father, Gary Pettijohn. "I would say it was moderate at best." Early in the morning of May 15, Pettijohn's mother took her to an emergency room. Going there, Pettijohn told her mom, would be quicker than waiting for an appointment with their family physician. Forty-two minutes later, Pettijohn was on her way to the drugstore. The doctor had diagnosed her with acute bronchitis and prescribed Avelox. The potent antibiotic's label says it's approved for cases of chronic, or long-term, bronchitis, and only after blood tests have been taken to identify the bacteria causing the problem. Her medical records show no blood work was done.

That was a Thursday. By Sunday, Pettijohn was nauseated and suffering abdominal pain. Her mother packed a plastic bag with the remaining Avelox pills and took her to the hospital. Over the next five days, Pettijohn was incoherent. She had a burning rash and her skin began peeling off. She slipped into a coma, resting on an air bed, totally wrapped as though she were a severe burn patient.

By Wednesday, a doctor approached Gary and Ruth Pettijohn. "Our problem just got twice as difficult," he said. "She has two life-threatening conditions simultaneously." Pettijohn's liver was in full failure, and she was experiencing a form of Stevens-Johnson syndrome, a rare and extreme drug reaction mentioned on the Avelox label.

She had a liver transplant on Friday. The doctors reported that her old liver had turned to mush and fallen apart in their hands. Soon after the operation, Pettijohn had a heart attack, then another. Her death certificate cited Avelox as the prime-contributing factor in her death. The hospital had no comment about her death. Bayer had no comment beyond saying the death "was promptly and accurately reported to the FDA," and that it thinks its antibiotic should be prescribed only for approved conditions.

Posted on Tue, Nov. 04, 2003

PART 3 of 3
FDA oversight of 'off-label' drug use wanes
By CHRIS ADAMS and ALISON YOUNG
Copyright 2003 Knight Ridder Newspapers