Yourlawyer.com (Cipro News)

Double Vision Possible Fluoroquinolone Side Effect

Wed, 09 Sep 2009 00:00:00 -0700

Fluoroquinolones, a class of antibiotics that includes Levaquin and Cipro, may cause double vision in some patients, according to a new study. The study appears in the September issue of Ophthalmology.

In conducting this latest fluoroquinolone study, researchers at Casey Eye Institute at the Oregon Health and Science University in Portland analyzed all eye-related adverse event associated with the drugs that had been reported in international databases and the medical literature between 1986 and 2008. The found 171 case reports of double vision. Of those, 75 cases were linked to Cipro, 9 to Tequin, 20 to Levaquin, 16 to Avelox, 11 to Noroxin and 40 to Floxin. In the 53 reported cases in which a patient stopped taking the medication, vision returned to normal quickly. In five of those cases where the patient was then given the drug again, the problem returned.

The more frequently prescribed fluoroquinolones were more likely to be the subject of double vision reports. This suggests that the problem involves the class of drugs rather than just one or two types of fluoroquinolones, the study authors said.

The study did not reach a conclusion as to the cause of the double vision, but did speculate that the antibiotics may have had an effect on tendons involving the eyes, impacting their ability to focus.

Fluoroquinolones are very strong antibiotics that are used to treat bacterial infections of the lungs, urinary tract and skin. They have been associated with a number of serious side effects, including tendonitis. Last July, the Food & Drug Administration (FDA) asked the manufacturers of fluoroquinolones to add a Black Box warning to the drugs’ labels because of their association with tendon damage. At the time, the FDA said the risk of tendon damage was greatest for those over age 60, those on concomitant steroid therapy, and kidney, heart, and lung transplant recipients. The ruptures generally related to the use of fluoroquinolones involve the Achilles tendon as well as ruptures of the shoulder, hand, biceps, and thumbs. At the time of the warning, he FDA has received nearly 2,250 reports of tendon disorders and 775 reports of tendon ruptures among patients taking fluoroquinolones.

Other side effects associated wit fluoroquinolones have included liver damage, gastrointestinal problems, skin phototoxicity and nervous system problems. Several fluoroquinolones, including Tequin, have been withdrawn from the market because of side effect issues.

Free Antibiotics Programs Criticized

Fri, 06 Mar 2009 00:00:00 -0800

In January we wrote about a promotional antibiotic giveaway campaign that had the Infectious Diseases Society of America (IDSA) concerned. Now, MSNBC is reporting that while giving away free antibiotics during the current economic downturn might have seemed the right course of action, health experts disagree.

Both the IDSA and the U.S. Centers for Disease Control and Prevention (CDC) wrote to five major retailers urging them to reconsider the promotion, explaining that the antibiotic giveaways adds to a growing problem involving drug resistant bugs that stems from antibiotic abuse and overuse, said MSNBC. “We were a little alarmed, especially when they suggested they’d be doing it during cold and flu season. We know that antibiotics aren’t effective for cold and flu. We don’t want to perpetuate the idea that they are,” said Dr. Lauri Hicks, medical director of the CDC’s program on appropriate antibiotic use.

Stores—such as Wegmans, ShopRite, Stop and Shop, and Giant Food—argue that they only fill doctor-mandated prescriptions, said MSNBC. “We feel like it’s a way to help our customers out during tough economic times,” said Jamie Miller, a spokesman for the 182-store chain Giant Food, quoted MSNBC. Experts disagree saying that the promotion prompts consumers to request antibiotics, noting that doctors often prescribe antibiotics just because a patient asked for the medications, said MSNBC. As a matter-of-fact, a study published last year in the British Medical Journal revealed that in some cases, doctors prescribe antibiotics like placebos for those patients who insist on leaving with a prescription. “It’s much easier to give someone an antibiotic than it is to explain to someone why they don’t need it,” said Dr. Ed Septimus, an internist who helped write the letters sent by the IDSA, said MSNBC.

“I was actually driving to work and saw this huge billboard that said ‘Come to Wegmans for free antibiotics,’” said Ann Marie Pettis, director of infection prevention at the University of Rochester Medical Center in Rochester, New York. “Here we are all working so hard to control the use of antibiotics and then to see something that’s well-intentioned but obviously ill-advised was surprising,” she added, said MSNBC.

Some say that the promotions bring in customers who will spend money on other items, a good deal given that the stores are spending pennies on the medications, said MSNBC. But, experts are concerned that the giveaways only add to the drug resistance problems that have now include superbugs such as methicillin-resistant Staphylococcus aureus (MRSA), and Clostridium difficile (C. diff), both of which can be seriously dangerous, even fatal.

Also, said MSNBC, about 142,000 annual emergency department visits are linked antibiotic use, many of which are allergic reactions, according to a recent study in the journal Clinical Infectious Diseases. “The fact is that antibiotics are not harmless,” said Hicks, the CDC specialist. “There’s a perception that antibiotics are like candy,” quoted MSNBC. Hicks also noted that she has urged the stores to help raise awareness of antibiotic use via the CDC’s program, “Get Smart: Know When Antibiotics Work.” Wegmans is one store which may be stocking the CDC information with the free antibiotics. Wegmans spokeswoman Jo Natale said Wegmans was surprised that health experts and doctors had such strong reactions. “Did we go to public health officials and ask their advice? We did not,” she said. “We should have had those conversations,” reported MSNBC.

It is a known medical fact that antibiotics do nothing to alleviate viral illnesses and their use carries risks. For instance, Cipro, an antibiotic in the fluoroquinolone group is used to treat bacterial infections and is linked to serious tendon injury and rupture; Levaquin has also been found to increase the risk of tendonitis and tendon ruptures. According to an earlier report by the Atlanta Constitution-Journal, the tendon risks associated with fluoroquinolones have been known for close to 20 years. Critics of fluoroquinolone antibiotics argue that the drugs were developed and put on the fast track for U.S. Food and Drug Administration (FDA) approval without adequate pre-market testing to accurately determine the probability of certain side effects. After gaining approval, the new antibiotics were aggressively marketed. According to the Atlanta Constitution-Journal, in 2007, U.S. patients received more than 40 million prescriptions for fluoroquinolone antibiotics.

Cipro, Levaquin Still Popular Despite Tendon Risks

Mon, 05 Jan 2009 00:00:00 -0800

Despite the fact that Cipro, Levaquin and other antibiotics called fluoroquinolones have been linked to serious tendon damage - including ruptures of the Achilles heel - not many patients are aware of the risk. According to an article in The Atlanta Constitution-Journal, drugs like Cipro and Levaquin are still being over-prescribed at an alarming rate in spite of this danger.

The first fluoroquinolone was introduced in 1986. Critics of these drugs allege that fluoroquinolone antibiotics were developed and put on the fast track for Food & Drug Administration (FDA) approval without the benefit of adequate premarket testing to accurately determine the probability of certain side effects within the general population. After gaining FDA approval, the new fluoroquinolone antibiotics were aggressively marketed by the manufacturers.

Cipro became widely known when it was used to treat and prevent anthrax infections in people exposed to the virus as a result of the 2001 mail attacks. While Cipro was apparently an effective weapon against anthrax, it left some victims with lingering health problems.

Last July, the FDA asked the manufacturers of Cipro and other fluoroquinolones to add a black box warning to the drugs’ labels about their association with tendon damage. The FDA said the risk of tendon damage was greatest for those over age 60, those on concomitant steroid therapy, and kidney, heart, and lung transplant recipients. The ruptures generally related to the use of fluoroquinolones involve the Achilles tendon as well as ruptures of the shoulder, hand, biceps, and thumbs. At the time of the warning, he FDA has received nearly 2,250 reports of tendon disorders and 775 reports of tendon ruptures among patients taking fluoroquinolones, though the actual numbers are likely much greater since most side effects are never reported.

According to the Atlanta Constitution-Journal, the tendon risks associated with fluoroquinolones have been known for close to 20 years. The FDA warning only came after the agency was sued by a consumer group for ignoring the drugs' safety risks.

When the FDA finally had the makers of these drugs add warnings to their labels, it stopped short of requiring that drug companies send letters to doctors alerting them of the change. Only a few, such as Bayer HealthCare Pharmaceuticals the maker of Cipro and Avelox, and Oscient Pharmaceuticals, which sells Factive, have voluntarily done so.

As a result, fluoroquinolones are still being prescribed at a high rate, despite the fact that there are safer alternatives. According to the Atlanta Constitution-Journal, in 2007, U.S. patients received more than 40 million prescriptions for fluoroquinolone antibiotics. What's worse, studies have shown that these drugs are often used to treat diseases that don't even respond to antibiotics.

The fact that few doctors and patients are aware of the risks of fluoroquinolones is a serious concerns. The tendon damage often caused by these antibiotics can be mitigated if patients are treated - and switched to another antibiotic - as soon as they start feeling pain. But without the right knowledge, most won't even know the medicine they are taking could be causing their discomfort. If they continue taking the drug, the result could be a tendon rupture, which will require even more intervention - including surgery.

Antibiotics Most Likely to Cause Drug Induced Liver Injury

Tue, 02 Dec 2008 00:00:00 -0800

Antibiotics are the drugs most responsible for the occurrence of drug induced liver injury (DILI), a new study has found. According to a press release announcing the study, DILI is the most frequent adverse drug-related event leading to abandonment of potentially promising new drug candidates during clinical trials and development.

DILI is the most common cause of death from acute liver failure and accounts for approximately 13 percent of all such cases in the U.S. It is caused by a wide variety of prescription and nonprescription medications, nutritional supplements and herbals.

"DILI is a serious health problem that impacts patients, physicians, government regulators and the pharmaceutical industry," Naga P. Chalasani, MD, lead author of the study, said in the press release. "Further efforts are needed in defining its pathogenesis and developing means for the early detection, accurate diagnosis, prevention and treatment of DILI."

The study, published in the journal Gastroenterology, consisted of an initial analysis of an ongoing prospective study of DILI. Its primary aim is to develop well-characterized cases of medication-related liver injury on which to conduct hypothesis-driven research targeted at developing means to diagnose, prevent and treat DILI, the press release said. Patients with suspected DILI were enrolled based upon predefined criteria and followed for at least six months. According to the press release, those with acetaminophen liver injury were excluded.

According to the Gastroenterology article, the study found that DILI was caused by a single prescription medication in 73 percent of the cases, by dietary supplements in 9 percent and by multiple agents in 18 percent. More than 100 different agents were associated with DILI; antibiotics (45.5 percent) and central nervous system agents (15 percent) were the most common, the press release said.

Of the dietary supplements causing DILI, compounds that claim to promote weight loss and muscle building accounted for nearly 60 percent of the cases. The study found that at least 20 percent of patients with DILI ingest more than one potentially hepatotoxic agent.

Researchers found no relationship between gender and severity of DILI, but individuals with diabetes experienced more severe DILI.

The researchers noted that DILI is a diagnosis of exclusion, meaning that detailed testing must be performed to exclude competing causes of liver disease. For that reason, the study authors recommended that in patients with suspected DILI, acute hepatitis C virus (HCV) infection should be carefully ruled out through the use of HCV RNA testing.

Antibiotics Can Disrupt Digestive Tract

Fri, 21 Nov 2008 00:00:00 -0800

The overuse of antibiotics is making the news again. This time, a newly released study is indicating that not only does the antibiotic commonly known as Cipro upset the bacterial balance in the digestive system, but those effects seem to be more long-lasting that first believed, reports The Canadian Press.

"You don't want to be giving readers the impression that we shouldn't be using antibiotics (when needed)," Dr. David Relman, senior author of the study told the Canadian Press. However, his study found that digestive effects from Cipro, and the negative symptoms of those effects, were still present in healthy patients six months after cessation of antibiotic treatment.

The study, which was published this week in the journal PLoS Biology, found that at the six month mark, “good” bacteria in the digestive tract were either present at decreased levels or not at all present.

According to the Canadian Press report, Relman did agree that “we do overuse antibiotics" and that digestive disruption is “the flip side. It's the trade-off part.” Relman is an infectious diseases specialist at Stanford University and the Veteran Affairs Hospital at Palo Alto, California. He conducted the study—funded by the Doris Duke Charitable Foundation and the U.S. National Institutes of Health—with a team of colleagues, said the Canadian Press.

The study noted that because antibiotics cannot target one bacteria while ignoring others, people can develop problems such as yeast infections or the diarrheal illness, C. difficile, from taking them.

According to the Canadian Press, Relman's team worked with three volunteers and the antibiotic ciprofloxacin, known as Cipro, which is considered the mildest of antibiotics when it comes to flora disruption. All three volunteers received one course of treatment with Cipro. The team “collected stool samples from their volunteers before they started, during treatment, and for months after,” reported The Canadian Press.

Although the study continues, actually extending out one year, and includes other volunteers, the article in PLoS Biology only refers to the first six months of study, said The Canadian Press. Over that time, the researchers found that “the diversity in bacterial types” decreased by “about one-third.” The large reduction surprised the team, according to Relman, who was also quoted by The Canadian Press as saying, "We find that Cipro was more disruptive than we had thought.... About 30 percent of all of the strains and species that we could see were disrupted. And most of them were ... either knocked out or knocked down."

Both the Infectious Diseases Society of America and the Society of Healthcare Epidemiology of America have published guidelines meant to minimize the spread of the C. diff superbug that include avoiding the overuse of antibiotics.

Coincidentally, earlier this month, the federal Centers for Disease Control and Prevention reported that cases of the C. diff diarrhea bug have been seen in all 50 states.

Antibiotic Side Effects Responsible for 140,000+ ER Visits Every Year

Thu, 14 Aug 2008 00:00:00 -0700

Overuse of antibiotics like Cipro and amoxicillan result in serious reactions that send more than 140,000 people to emergency rooms every year. Those starting statistics provide yet another reason for doctors to limit their use of the drugs.

The findings are part of a new study on antibiotic reactions in the U.S. - the first of its kind -conducted by the Centers or Disease Control (CDC). The researchers used the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project, a sample of 63 U.S. hospitals, between 2004 and 2006. According to their survey, the hospitals recorded more than 6,600 emergency visits that were due to an adverse reaction to an antibiotics. They were able to extrapolate this to the whole country and estimated that 142,000 such emergency visits are made every year.

Systemic antibiotics (pills or injections as opposed to creams) were implicated in 19.3 percent of all emergency department visits for drug-related adverse events," they wrote in the September 15 issue of Clinical Infectious Diseases.

Penicillin and related antibiotics such as amoxicillin - among the most trusted and widely prescribed drugs - accounted for half the emergency visits. Other classes of antibiotics such as cephalosporins, fluoroquinolones - the class that includes Cipro - and newer antibiotics accounted for the rest.

The study found that 78 percent of the adverse events in the study were allergic reactions, ranging from rash to a serious reaction known as anaphylaxis, and the remaining 22 percent were caused by errors and overdoses.

The researchers said that their findings prove that overuse of antibiotics is a serious public health problem. "This number is an important reminder for physicians and patients that antibiotics can have serious side effects and should only be taken when necessary," said the CDC's Dr. Daniel Budnitz, who led the study.

Some studies have found that half of the estimated 100 million antibiotic prescriptions written for respiratory tract infections in the U.S. are unnecessary. The majority of these functions are caused by viruses, and antibiotics are useless against them.

Serious reactions to antibiotics are nothing new. Last month, the Food & Drug Administration (FDA) asked the manufacturers of Cipro and other fluorquinolones to add a black box warning to the drugs’ labels about their association with tendon damage. The FDA said the risk of tendon damage was greatest for those over age 60, those on concomitant steroid therapy, and kidney, heart, and lung transplant recipients. The ruptures generally related to the use of fluoroquinolones involve the Achilles tendon as well as ruptures of the shoulder, hand, biceps, and thumbs

Cipro Tendon Injury Still Plagues Anthrax Attack Victim

Fri, 08 Aug 2008 00:00:00 -0700

Victims of the 2001 anthrax attacks are still dealing with some difficult health issues. Surprisingly, their difficulties have nothing to do with the deadly virus itself, but rather were caused by Cipro, the medicine that was supposed to make them well.

Cipro belongs to the antibiotic group known as fluoroquinolones. Fluoroquinolones are known to carry a number of risks. These include liver problems and tendon damage. The first fluoroquinolone was introduced in 1986, but they are really modified quinolones, a class of antibiotics discovered in the early 1960s. Critics of these drugs allege that fluoroquinolone antibiotics were developed and put on the fast track for Food & Drug Administration (FDA) approval without the benefit of adequate premarket testing to accurately determine the probability of certain side effects within the general population. After gaining FDA approval, the new fluoroquinolone antibiotics were aggressively marketed by the manufacturers.

Cipro became widely known when it was used to treat and prevent anthrax infections in people exposed to the virus as a result of the 2001 mail attacks. While Cipro was apparently an effective weapon against anthrax, it left some victims with lingering health problems.

One of those was John Angell, who was working on Capitol Hill as staff director for Senator Max Baucus (D-Mont.) when the anthrax attacks occurred. While not diagnosed with anthrax, like hundreds of other people, Angell took a course of Cipro to prevent infection. He told The Wall Street Journal that a few days later, he felt pain in both his Achilles tendons. A week after that, the pain had grown so bad that he talked to a doctor, who switched him to another antibiotic.

Angell's Cipro injury was so bad, that he became all but immobile for a time. He had to undergo rehab, and missed a great deal of work. He had to give up his staff director position, and now holds a much less senior job. Even today, Angell still walks with a cane and can’t hike or play tennis the way he used to.

Last month, the FDA asked the manufacturers of Cipro and other fluorquinolones to add a black box warning to the drugs' labels about their association with tendon damage. The FDA said the risk of tendon damage was greatest for those over age 60, those on concomitant steroid therapy, and kidney, heart, and lung transplant recipients. The ruptures generally related to the use of fluoroquinolones involve the Achilles tendon as well as ruptures of the shoulder, hand, biceps, and thumbs

Unfortunately, the new black box warning came too late for John Angell and many others like him.

FDA To Seek Black-Box Warning On Cipro and Levaquin

Tue, 08 Jul 2008 00:00:00 -0700

The U.S. Food and Drug Administration (FDA) has announced that it will seek to add black box warnings about the risk of tendon rupture associated with Cipro and Levaquin. The drugs are in a class of antibiotics used to treat bacterial infections and black box warnings are the strongest warning the FDA issues. Cipro is made by Bayer AG and Johnson & Johnson makes Levaquin. Six months ago, the consumer group Public Citizen sued the FDA to require it to add black-box warnings to the drugs.

Cipro and Levaquin belong to the antibiotic group known as fluoroquinolones, which are sold by several drug makers under a variety of brand and generic names. Although the drug labels warn of the risk of tendon ruptures, none include black-box warnings. A black-box warning is in bold type, surrounded by a black box to make it stand out. Such warnings usually appear at the top of drug labels. Any advertising of products that carry black box labels must also include the black box warning information as part of the advertisement. The FDA also announced it will ask the drug companies to create a Medication Guide to be provided to patients to alert them about possible side effects.

Serious reports of tendonitis and tendon rupture are on the rise with the use of these drugs, which finally prompted the FDA to ask drug companies to add the stronger labeling. The ruptures generally related to the use of fluoroquinolones involve the Achilles tendon as well as ruptures of the shoulder, hand, biceps, and thumbs. Tendons are the areas that connect your muscles to your joints. The Achilles tendon is at the back of the ankle. The risk of tendonitis and tendon rupture linked to drugs such as Cipro and Levaquin is "especially increased" in patients older than 60, as well as those who have received kidney, heart, or lung transplants and people on “concomitant” steroid therapy.

Fluoroquinolone Antimicrobial Drugs include: Cciprofloxacin, marketed as Cipro and generic ciprofloxacin; ciprofloxacin extended release, marketed as Cipro XR and Proquin XR; gemifloxacin, marketed as Factive; levofloxacin, marketed as Levaquin; moxifloxacin, marketed as Avelox; norfloxacin, marketed as Noroxin; and ofloxacin, marketed as Floxin and generic ofloxacin.

The FDA believes that the addition of a black box warning and a Medication Guide would strengthen the existing warning information already included in the prescribing information for fluoroquinolone drugs.

The FDA warns that physicians “should advise patients, at the first sign of tendon pain, swelling, or inflammation—symptoms that typically precede tendon rupture and tendonitis—to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug.” Fluoroquinolone is only suggested for the treatment or prevention of an infection proven to be caused by, or strongly suspected to be caused by, bacteria.

According to the FDA release, other side effects experienced in those taking Fluoroquinolones include “seizures, hallucinations, depression, heart rhythm changes (QTc prolongation and torsade de points), and intestine infection with diarrhea. Rarely, damage to the liver, kidneys or bone marrow, and changes to blood sugar may occur.”

Antibiotic Lawsuit Seeks Stronger Warnings on Cipro, Levaquin and Others for Tendon Damage

Fri, 04 Jan 2008 00:00:00 -0800

Cipro, Levaquin and other antibiotics known as fluoroquinolones have long been known to cause serious side effect, including tendon damage. Yet despite massive amounts of evidence, the Food & Drug Administration (FDA) has not required the makers of Cipro, Levaquin and other fluoroquinolone antibiotics to add warning labels about their links to ruptured tendons and other tendon problems. Now, the consumer advocacy group Public Citizen is trying to force the FDA to act, and has taken it to court in attempt to compel the agency to add black box warnings about tendon problems to the labels of these antibiotics.

Fluoroquinolones are used to treat bacterial infections in many different parts of the body. They work by killing bacteria or preventing their growth. From November 1997 through December 2005, the FDA received 262 reports of tendon ruptures, mainly of the Achilles tendon, 258 cases of tendinitis and 274 cases of other tendon disorders in patients using fluoroquinolone antibiotics. An additional 74 tendon ruptures have subsequently been reported to the FDA for a total of 336. But Public Citizen contends that only a small fraction of cases are typically reported to the FDA, so the actual number of ruptures and other tendon injuries attributable to the antibiotic is probably much higher.

Public Citizen announced yesterday that it had sued the FDA in the U.S. District Court for the District of Columbia over the issue of floroquinolone antibiotics and tendon damage. Public Citizen wants the court to force the FDA to act upon a petition the consumer group filed with the agency 16 months ago. So far, the FDA has failed to respond to the petition, which asked the agency to put a “black box” warning on fluoroquinolone antibiotics to make doctors and patients are more aware of the risk of serious tendon injury before tendons actually rupture.

The Public Citizen petition also urged the FDA to send a warning letter to physicians, as well as require an FDA-approved medication guide to be dispensed when prescriptions are filled. In a press release announcing the antibiotic lawsuit, Public Citizen asserted that stronger warnings could lead to earlier intervention and prevent needless injuries by allowing doctors to switch patients to other antibiotics. “While the FDA sits idly by and ignores the problem, more people will suffer serious tendon ruptures that could have been prevented,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “The current warning is buried in a long list of possible adverse reactions and is far too easy to miss.”

Public Citizen said in its complaint that by failing to act upon its fluoroquinolone petition, the FDA is violating the Administrative Procedure Act.

Despite Side Effects, Antibiotics Being Tested For Children

Sun, 15 Aug 2004 00:00:00 -0700

Companies that produce a group of powerful antibiotics are being encouraged by the federal government to move into the pediatrics market, even though the drugs' use for children has been discouraged for a decade because of severe side effects.

The Food and Drug Administration in March approved the use of ciprofloxacin, or Cipro, for some kidney and urinary tract infections in children under 18, in the event other antibiotics failed to work.

And two clinical trials are under way to demonstrate that another drug, Levaquin, is a safe and effective treatment for pneumonia and middle ear infections in children.

Both Cipro and Levaquin belong to a class of pharmaceuticals called quinolones. The drugs, which include Avelox, Tequin, Floxin and others, have been hailed as life-saving medications that often work when other antibiotics have failed. Hundreds of millions of doses are prescribed every year.

After anthrax spores were released in Florida, New York, Washington, D.C., New Jersey and Connecticut in the fall of 2001, the Centers for Disease Control and Prevention recommended that more than 10,000 people take Cipro as a safeguard.

Johnson & Johnson Corp., which markets Levaquin through its subsidiary, Ortho-McNeil Pharmaceuticals Corp., reported to the Securities and Exchange Commission that Levaquin sales last year were over $1 billion.

But those positive figures, and the risk-benefit calculations that led the FDA to move to open pediatrics markets to quinolones, do not impress thousands of people who say they have suffered adverse reactions from the drugs.

"There are people who are sitting ducks, waiting to have the side effects of these drugs, which are very effective antibiotics that work often for millions of other people," said Dr. David Flockhart, chief of the Division of Clinical Pharmacology at Indiana University School of Medicine.

Adverse side effects either listed by quinolone manufacturers on drug labels or reported to the FDA's Adverse Events Reporting System include moderate to abnormal sensitivity to light, grand mal seizures, heart arrhythmia, toxic psychosis and ruptured tendons.

"It's pure evil," said John Angell, a Senate staffer who had Achilles tendon injury after taking Cipro in the aftermath of the 2001 anthrax attack.

The fact that quinolones can damage tendons in adults has led some experts to worry about the impact they may have on growing cartilage in children.

Flockhart recalls examining a teen-age girl from the Chicago suburbs after she had been given Levaquin four years ago for a condition that was diagnosed as a sinus infection.

The 35-page FDA-approved label for Levaquin, also known by the generic term levofloxacin, contains the following warning:

"The safety and efficacy of levofloxacin in pediatric patients, adolescents under the age of 18 years, pregnant women and nursing women have not been established."

The Chicago teen-ager is one of 81 persons from 1 to 17 years old whose adverse reactions to Levaquin, Cipro or Floxin appear in the FDA's adverse events data base.

These reactions ranged from nausea to coma and cardiac failure, according to the data base. The side effect listed, without explanation, for one 16-year-old girl was "murder."

The Chicago teen-ager was also 16 when a physician told her mother to give her Levaquin, according to the girl's sister.

The sister, Mrs. Teri Noto of Roselle, Ill., said the teen-ager did not get through the full course of daily 500-milligram Levaquin pills.

"After five days, it was as if a bomb went off in her body," said the sister. "She collapsed at school and had to be half-carried out of the building."

Noto said her sister had been a talented musician, artist and athlete, advancing to within a few points of a black belt in Tae Kwon Do karate.

The girl, now 20, can walk only a short distance at a time, according to her sister. She attends college and gets around on an electric scooter.

She has had 29 orthopedic casts to prevent tendon rupture in her arms and legs, her sister said, and the hands that once played the piano and executed the swift movements of karate are often too weak to pick up a book.

More than 2,000 children with pneumonia or ear infections will be receiving Levaquin in trials being sponsored by Johnson & Johnson Pharmaceutical Research & Development Corp.

The ongoing pneumonia trials stopped recruiting subjects two weeks ago. Children age 6 months to 5 years are still being recruited for the otitis media, or ear infection, trial.

The purpose of that trial is to compare the effectiveness and safety of Levaquin with another antibiotic, Augmentin, according to information posted on a government Web site, clinicaltrials.gov.

Dr. Edward Goldblatt, an Alabaster, Ala., pediatrician, said he signed up to participate in the trial but withdrew because it required so much time. He said he hoped the trial succeeded, because "we need another antibiotic for this condition."

"There are some antibiotic-resistant pneumonias and ear infections in children that can be most severe," he said. "Some of them are resistant to just about anything we can give by mouth."

Ortho-McNeil spokespersons said the company organized clinical trials of Levaquin for pediatrics use at the request of FDA.

They said that because of growing bacterial resistance to drugs, the agency is eager to increase the number of antibiotics available for use in children.

In addition to the warning that Levaquin has not been shown to be safe for children, the drug label states that experiments on immature animals of several species showed that it and other quinolones harmed cartilage and eroded weight-bearing joints.

Ortho-McNeil spokeswoman Leslie Fishman said concern that quinolones might hinder the growth of cartilage in children was based solely on these animal studies.

"There was concern at the outset, but there has never been a report of cartilage damage in a child," she said. "Based on the available data, it (the early concern) did not pan out."

She provided a paper published this year by scientists from Israel, Costa Rica and Switzerland, all of whom disclosed that they receive research funding from Johnson & Johnson or other pharmaceutical companies that produce quinolones.

The paper concluded that cartilage damage by quinolones "is a laboratory phenomenon in juvenile animals" and has not been documented in children who were given the drugs because of hard-to-treat infections.

FDA officials declined to answer questions on the record about the issue of quinolones and children. Speaking on background, an official said the agency faces a complicated decision in the matter.

The fact that laboratory studies show cartilage deformation in juveniles from several species, including rats, guinea pigs and dogs, rather than just one species that might have a unique susceptibility, is significant, the official said.

Also, doses used in these experiments were similar to levels that would be given to children.

On the other hand, with growing problems of bacterial resistance to antibiotics and the fact that a child might be allergic to another drug, the agency's scientific advisers have urged it to establish safe quinolone levels as backup drugs for children.

Some doctors don't believe anything should be done to weaken restraints on use of quinolones.

"I feel these drugs should be used only by specialists in infectious disease," said Dr. Edward Cooper, a general practitioner who works at a walk-in clinic in San Jose, Calif.

Cooper said the drugs are commonly prescribed as first-line antibiotics when they should not be used in most cases unless other antibiotics have been shown not to work.

The problem is exacerbated, some doctors and researchers say, by errors in prescribing the drug in a climate unduly influenced by the high-pressure sales tactics of pharmaceutical manufacturers.

"The drug reps will come by and extol the virtues of the medications and we get mailings every two months about how good these medications are," Cooper said. "But they rarely tell doctors about the side effects."

"I feel that it is like a dysfunctional family where no one is allowed to talk about the father's drinking problem despite all the evidence to the contrary," he said.

Records that came to light last year in an employment discrimination lawsuit in Chicago depict a sales climate consistent with Cooper's observations.

In the suit, lawyers for Ortho-McNeil successfully moved to suppress evidence about "the efficacy, appropriate medical use, potential side effects and/or cost of Levaquin."

Minutes of a meeting held in June 2000 and entered as evidence in the trial describe sales representatives being exhorted to push Levaquin.

They were urged to increase their calls to hospital officials, take them to lunch and sponsor office Christmas parties, the minutes show.

They were told to refer to Augmentin (the drug against which Levaquin will be compared in the children's ear infection trial) as a "horse pill" and use a large piece of hard candy as an illustration, according to the minutes.

A federal judge directed a jury to rule in favor of Ortho-McNeil in the job discrimination matter and the plaintiff has appealed. Ortho-McNeil spokesman Fishman said the company could not comment about ongoing litigation.

In 1996, Ralph Nader's Public Citizen consumer advocate organization petitioned the FDA to require that quinolone labels contain warnings about tendon rupture, a step cautious European regulators already had taken.

Public Citizen requested that the warnings be printed in boldface type and that the agency send a "Dear Doctor" letter to all physicians, specifically calling their attention to the danger.

The FDA required the warnings -- on page 15 of the 35-page label and not in boldface type -- but did not send the letter.

Larry Sasich, a Public Citizen pharmacist who signed the petition, said this was disappointing.

"We thought it was necessary to raise a red flag," said Sasich, "because who would suspect that you would get tendon rupture from an antibiotic?"

He said doctors seldom have time to read lengthy drug "labels."

In fact, researchers at the University of Pennsylvania School of Medicine last year analyzed 100 quinolone prescriptions written in a hospital emergency room and found that only one of them was written for the right condition and in the right dosage.

Dr. Ebbing Lautenbach, an epidemiologist, said in an interview that he and the other researchers were primarily concerned not with adverse reactions but by worries that overuse of quinolones would accelerate the development of quinolone-resistant germs.

He said that after analyzing a random prescription for the antibiotic and the 99 subsequent prescriptions for the same quinolone, they found:

In 43 cases, another drug was considered the proper first-line treatment.

In 27, there was no documentation of infection.

In 11, there was no way to assess the need for antibiotics.

In the remaining 19 cases, quinolones were found to have been the correct medication, but only one of these patients received the correct dose for the correct duration.

No one knows how many Americans experience adverse reactions to quinolones each year. The FDA estimates that between one and 10 percent of all adverse drug reactions are reported to its Adverse Events Reporting System.

They say the system is intended to help them spot trends in drug side effects and is not a comprehensive accounting of drug reactions.

Because of the Internet, persons who believe they have been harmed by quinolone side effects are becoming more and more visible. Bound together by Web sites on which they share stories, they have formed a bitter electronic community.

Flockhart is skeptical about some of the self-reported reactions. Such people may have some other problem and until they are examined by a physician trained in clinical pharmacology, no one will know what they have, he says.

Others, he also believes, have quinolone reactions that are misdiagnosed as something else.

"Quinolones are really the tip of the iceberg," he said. "It's the general fact that we're not good at recognizing and treating adverse drug reactions in primary care."

Anthrax Drug Blamed For Lingering Ailments

Sun, 20 Oct 2002 00:00:00 -0700

For some American Media employees, veterans of last year's agonizing anthrax scare, it isn't over yet.

A very small number of people say they continue to suffer physical problems that are both persistent and perplexing. They attribute those discomforts to the drug they were given to fight possible anthrax poisoning Cipro a product of the Bayer Corp.

In fact, some have decided that the medicine has posed more of a threat to them than the malady a claim challenged by some doctors involved in the crisis and by the company. But the federal Centers for Disease Control and Prevention in Atlanta is concerned enough that it is in the middle of a two-year study of people who took anthrax antibiotics.

"I think the stuff is horrible and wish I hadn't taken anything," says a 45-year-old mother of two who still works at AMI and asked that her name not be used. "Ten days into taking it, I got pains in my right foot, and then it started in my left Achilles tendon. I stopped taking it after 20 days, but in all the months since I haven't taken a step that I didn't feel it."

Computer technician Rick Stonecypher was working at AMI as a contract employee last October when anthrax was discovered in the Boca Raton building, and he took Cipro as recommended by county health authorities.

"I've had respiratory problems ever since," he says, adding that his doctors have him taking Allegra, an over-the-countermedicine for allergies that he never needed before.

Jill Perel, wife of David Perel, editor of AMI's The National Enquirer, suffered severe illness after taking Cipro, including vomiting, major muscular pain and pounding headaches, and had to be hospitalized. She stopped taking it after seven days.

"I figured it would be easier to die of anthrax," she said recently, although she has now recovered fully.

"But there are employees who have suffered more than I have," Perel says. "I know there are people, especially those who are very physically active, who've had problems. It seems the more physically active a person is, the more problems they've had and some of them run marathons."

None of those interviewed hesitated to take the Cipro when it was offered, and they all signed releases freeing county health authorities of responsibility.

'We were all flipped out'

The releases were requested because, with fears of bioterrorism growing among federal officials, Cipro was approved in 2000 for treatment of anthrax poisoning, but it had to be done without testing on humans because there were no anthrax victims to test it on.

"I don't really know what I signed. We were all flipped out," says the mother of two. "I would have signed to take poison, that's how afraid we were."

Stonecypher agrees. He was asked to provide a verbal release, which was taped.

"I would have said anything to know what was happening to me," he says.

According to the CDC, 1,132 people who either worked for AMI, were related to employees, had been in the building in the previous 60 days or worked at post offices that processed AMI mail took antibiotics. Most 86 percent were put on Cipro, two 500 mg doses per day, and the recommended duration was 60 days. The others including children and pregnant women were given either amoxicillin or doxycycline, also antibiotics, and were also placed on 60-day regimens. Cipro is not approved for children or pregnant women because clinical testing showed cartilage and tendon damage in immature rats.

A study by the CDC released this month revealed that of 5,343 people studied who took the anthrax antibiotics last year not only in Florida but in New York, New Jersey and Washington, D.C. 57 percent reported adverse side effects while they were taking the drugs. Almost all were minor, with the most common being nausea, vomiting, headaches and dizziness, but some also suffered tendinitis, fainting spells and seizures. Sixteen percent of those people, including Jill Perel, were sick enough to require medical attention.

Cipro Lawyer Tendon Rupture Attorneys Injury Lawyers

Sun, 20 Oct 2002 00:00:00 -0700

Cipro Lawyers

Keywords: Cipro Lawyer Tendon Rupture Attorneys Injury Lawyers

The lawyers and attorneys at our firm are offering free consultations to individuals who experienced tendon ruptures and tendonitis after treatment with the antibiotic Cipro. If you or a loved one suffered a tendon injury as a result of this antibiotic, we urge you contact one of our Cipro injury lawyers right away.

Cipro is a member of the fluoroquinolone group of antibiotics, prescribed to treat bacterial infections of the abdomen, bones, urinary tract skin and lower respiratory system. Health officials prescribe Cipro to combat bronchial infections, typhoid fever, prostate gland infections and tuberculosis. Cipro gained notoriety in 2001, when it was used to treat victims of the anthrax attacks.

Cipro and Tendon Ruptures

Since its approval, our Cipro injury lawyers have heard from many individuals who suffered serious tendon injuries - including ruptures - as a result of treatment with Cipro. On Nov 8, 2003 a study conducted in Germany on lab rats showed that the rats' Achilles tendons suffered "degenerative alterations" shortly after being given Cipro. In the study, ruptures continued to occur even after the rats stopped taking Cipro.

In January 2008, the consumer advocacy group Public Citizen filed a lawsuit against the Food & Drug Administration (FDA) in an attempt to compel the agency to act on a petition filed it filed 16 months prior requesting that new warnings be added about side effects of Cipro and other antibiotics, which could increase the risk of tendonitis and tendon ruptures. At the time of the filing, Public Citizen said the FDA had received reports of at least 336 individuals who experienced a tendon rupture after using Cipro, one of the fluoroquinolone antibiotics. The most common tendon rupture involved the Achilles tendon. .

Finally in July 2008, the FDA directed the maker of Cipro to add a black box warning to the drug's label about is association with tendon damage. The FDA said that Cipro and other fluoroquinolones had been associated with tendonitis and tendon ruptures. The risk is greatest for those over age 60, those on concomitant steroid therapy, and kidney, heart, and lung transplant recipients.

The FDA warned that Cipro treatment should be stopped if a patient experiences pain or inflammation in a tendon (symptoms that may precede rupture of the tendon), or tendon rupture. Health care professionals were told to advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking Cipro, to avoid exercise and use of the affected area, and to promptly contact their healthcare provider about changing their medication.

Cipro and Toxic Epidermal Necrolysis

Our Cipro injury lawyers are also offering free consultation to anyone who developed Toxic Epidermal Necrolysis (TEN) following therapy with Cipro. In May 2005, a warning was added to the label of Cipro regarding its association to TEN. TEN - also called Lyle's Syndrome - is a life-threatening skin condition that is frequently induced by a reaction to medications.

TEN affects many parts of the body, but it most severely affects the mucous membranes, such as the mouth and eyes. These severe symptoms are often preceded by 1 to 2 weeks of fever, and many victims at first believe they are suffering from a common upper respiratory tract infection.

When the rash appears it may be over large and varied parts of the body, and it is usually warm and appears red. In hours, the skin becomes painful and the epidermis can be easily peeled away from the underlying dermis. The mouth becomes blistered and eroded, making eating difficult and sometimes necessitating feeding via a tube through the nose or stomach. The eyes are affected, becoming swollen, crusted, and ulcerated.

TEN is often fatal. Patients with the disorder should be hospitalized and highly specialized nursing care given, often in an intensive care unit. In some situations patients may be treated in a burn unit.

Legal Help for Victims of Cipro Injuries

If you or a loved one suffered a serious injury, such as a tendon rupture or TEN, you have valuable legal rights. Please fill out our online form or call 1-800-LAW-INFO (1-800-529-4636) to speak with an experienced Cipro injury lawyer about your case.