Investigative Report: Cipro – What You Don't Know Can Hurt You
Kevin Curran, NewsMax.com
Thursday, Nov. 29, 2001
It is a simple medical equation: Anthrax exposure + Cipro = cure. Or does it?
A NewsMax.com investigation of the reaction to the recent anthrax episodes has found the pursuit of a treatment has opened the door for misinformation, confusion and the protection of a major pharmaceutical company.
Since the initial attacks, health officials have approved other drugs for post-exposure anthrax treatment and are testing still more. These alternate antibiotics come with their own complicating factors.
The future of anthrax treatment is murky. Federal officials, health experts and drug companies continue to search for better methods of handling patients exposed to anthrax.
The problems of the military's anthrax vaccine program will be revisited. Other methods to prevent or treat anthrax will also be tested, sometimes with bad results.
What American citizens are watching amounts to a large science experiment, but the laboratories could be anywhere, including New York's subway system and a small Connecticut hospital, and the guinea pigs are human beings facing a disease virtually unknown in the general medical community before October.
Cipro Not Benign
As anthrax fears spread, health officials initially recommended that people with potential exposure begin taking the antibiotic known as Cipro for 60 days.
Cipro is the trademark for ciprofloxacin hydrochloride, a drug first approved by the FDA in 1987. It is manufactured by Bayer and was the only drug with a specific FDA approval for treatment of post-exposure anthrax.
As more exposures were reported, thousands rushed to their physicians, seeking prescriptions for Cipro. Others have bypassed the normal methods and tried obtaining the drug through other sources, including foreign pharmacies.
Now that treatments are under way, those same health officials who recommended Cipro are receiving reports of its dark side and are finding other drugs that may be just as effective in treating anthrax, at a much lower cost.
The FDA's Center for Drug Education and Research warns patients that Cipro's side effects can include disorders of the central nervous system like dizziness, confusion and depression. It can also prompt an allergic reaction such as breathing difficulties, swelling or hives. Other side effects include pain, inflammation or ruptures of tendons, colon tissue inflammation or increased sensitivity of skin to sunlight.
Cipro is part of a group of antibiotics known as fluoroquinolones. Other drugs in this group include levofloxacin, marketed as Levaquin, lomefloxacin and ofloxacin.
"That drug absolutely ruined my life," said Linda Baldwin, 61, of Oxnard, Calif. "It makes me heartsick watching people on TV grabbing up Cipro," she told the Los Angeles Times Oct. 29, "when they're not even sick and letting themselves in for so many adverse reactions that their doctors may not even recognize."
Baldwin was given Cipro and another fluoroquinolone for a urinary tract infection in 1996. She claims the drugs prevent her from working and enjoying her grandchildren as she deals with blurred vision, muscle pain and other side effects.
Author Stephen Fried knows first-hand the debilitating effects of fluoroquinolones. In his 1998 book, "Bitter Pill: Inside the Hazardous World of Legal Drugs," he discussed his wife's battle against the effects of a single antibiotic tablet she took in 1992 for a urinary tract infection.
Fried says she was so delirious six hours after taking the pill that she had to be taken to an emergency room. For nine years, she has been treated for a manic-depressive illness.
Some postal workers are also wondering about the wisdom of passing out Cipro. John Ford, 66, is a representative of the postal workers union who frequently visited the Brentwood mail facility in Washington, D.C.
Ford told USA Today Oct. 31 that he developed nausea, vomiting and cramps after taking the antibiotic. "Being a reasonable person, I thought I'd rather have this than anthrax," said Ford.
He added that side effects have required hospitalization for two of his union members and sent a third to an emergency room.
In Florida, reports of Cipro's side effects prompted state officials to establish a 24-hour hotline to gather information and provide guidance. State epidemiologist Steven Wiersma told the Miami Herald Nov. 3 that "these drugs have some pretty severe side effects, and they shouldn't be taken lightly."
After the anthrax exposure at American Media in Boca Raton, Fla., 970 people were given 60-day Cipro prescriptions. Eighty percent of them were still taking the drug two weeks later.
Of those, 95 patients reported itching, breathing problems, or swelling of the face, neck or throat, or had sought medical attention for adverse side effects. Six of them stopped taking Cipro after going to a doctor's office or emergency room, or in two cases, requiring hospitalization.
"The adverse events that people are reporting in Florida are no different than what we've typically seen," CDC deputy director Julie Gerberding told the Los Angeles Times Nov. 9.
Dr. Gerberding does not agree with those who think antibiotics have been over-prescribed. "[W]hen we have the immediate event where there's a case of anthrax, or a powdered envelope that proves to be anthrax, we cannot immediately ascertain who's at risk for exposure."
Physicians Respond
At the American College of Physicians, president William Hall is also not surprised by reports of adverse reactions. "It's not a question of if, but when, people are going to get side effects from a broad-spectrum antibiotic."
Hall will be carefully watching reports of these anthrax prevention treatments. "We need to really understand what's the implication of putting thousands of people on an antibiotic for two months. There's never been an experience like this in the world. We have no idea what to expect from this."
Another doctor with his eyes on the treatment is Jay Cohen, a professor at the University of California, San Diego. Cohen recently completed a study on the side effects of fluoroquinolones that was supposed to be published in the December issue of The Annals of Pharmacotherapy.
The sudden interest in these drugs prompted the journal's editors to post the study's results on its Web site in advance of publication.
Cohen found that patients who have side effects from Cipro and its related drugs find out quickly: 58 percent of those in his study reported adverse events within 72 hours of taking the drug.
These effects tend to linger: 80 percent of the patients reported severe discomfort or limited functions that lasted more than two months. Cohen reported following one case that has lasted six years.
Not only do the effects tend to linger, they also are hard on the patients. Only 20 percent of the patients reported mild or moderate symptoms; 80 percent of them said the symptoms were severe.
Perhaps the most striking result of Cohen's research was the resistance of some physicians to recognize side effects as side effects.
Prescribing doctors "have difficulty admitting it," Cohen told NewsMax.com. "When they see patients with side effects, they think they are something else. The doctors are not comprehending there could be multiple effects from one drug."
Cohen said patients rushing to their doctors for a prescription must understand that "Cipro is not benign."
Furthermore, Cipro is the strongest broad-based antibiotic available and Cohen felt its use should be reserved for resistant strains of anthrax.
Cohen was happy to see the growing use of doxycycline as a post-exposure treatment. Doxycycline is another broad-spectrum antibiotic, but is not a member of the fluoroquinolone family. "Most doctors think doxycycline is the way to go," Cohen said, "since it is safer and better known."
In the immediate aftermath of the anthrax outbreaks, some people became instant doctors. "I've been trying to hold back my own friends and relatives who are trying to get this stuff," Dr. Stephen Baum of New York's Beth Israel Medical Center told CBS News Oct. 26.
Prescriptions for Cipro almost tripled in the New York area, despite requests from doctors and health officials that patients not create personal stockpiles.
Continued tomorrow in Cipro – Part Two
newsmax.com |
