Yourlawyer.com (Levaquin News)

Study Sees Higher Liver Risks with Levaquin, Avelox Antibiotics

Tue, 14 Aug 2012 00:00:00 -0400

Levaquin (levofloxacin) and Avelox (moxifloxacin), antibiotics known as fluoroquinolones, have been linked to an increased risk of severe liver injuries in elderly people. According to a new study published August 13 in the Canadian Medical Association Journal, of the two drugs, Avelox has the highest liver injury risk, but it and Levaquin are both associated with a statistically significant risk of hepatotoxicity.

Levaquin, Avelox and other fluoroquinolones are used to treat bacterial infections including respiratory infections and sinus infections. In recent years, health regulators in Europe and Canada have issued liver injury warnings for Avelox. However, few studies have been conducted to the safety of fluoroquinolones, especially related to liver damage.

For this new study, Canadian researches examined the risk of acute liver injury in patients taking Avelox compared with those taking other commonly used antibiotics. They analyzed the medical records of 144 patients in Ontario who were over 65 and admitted to the hospital to treat liver injury within a month of receiving one of the antibiotics. None of the subjects had a previous history of liver disease. Of the 144 patients studied, 88 patients died during their stay in hospital.

Overall, Avelox was associated with a more than 2-fold increased risk of admission to hospital for acute liver injury compared to clarithromycin. Avelox had a higher risk than Levaquin, but Levaquin's association with liver injury was still statistically significant, the study authors said.

The study authors called for further studies of Levaquin and Avelox, as well as additional safety warnings regarding their association with acute liver injury.

"Despite recent regulatory warnings regarding the hepatic safety of moxifloxacin, there is a lack of controlled studies supporting the notion that moxifloxacin presents a particular risk relative to other broad-spectrum antibiotic agents and, in particular, to other fluoroquinolones," write the authors.

"Although our results require confirmation in other settings, the findings suggest that both moxifloxacin and levofloxacin be considered for regulatory warnings regarding acute liver injury,” they conclude.

Feds Say Kickbacks Paid to Increase use of Risperdal, Levaquin at Omnicare Nursing Home Change

Mon, 18 Jan 2010 00:00:00 -0500

Johnson & Johnson has been charged with paying kickbacks to the Omnicare nursing home chain in order to increase the use of its drugs at the chain's homes. While Johnson & Johnson was allegedly paying kickbacks, federal prosecutors claim that Omnicare’s annual purchases of the company's drugs, including Risperdal and Levaquin, nearly tripled to more than $280 million.

In November, Omnicare agreed to pay $98 million to settle charges related to the alleged Johnson & Johnson kickback scheme. As part of the settlement, Omnicare entered into a corporate integrity agreement with the Department of Health and Human Services.

According to allegations contained in a complaint filed by the U.S. Attorneys office in Boston, from 1999 to 2004 Johnson & Johnson paid kickbacks to Omnicare in a variety of forms, including rebates, grants and educational funding. The claims against Johnson & Johnson were initiated by whistleblowers who could receive a share of any money the government collects.

The complaint charges that Johnson & Johnson was aware that Omnicare pharmacists made recommendations to physicians about what drugs should be prescribed to home residents. The complaint repeatedly mentions internal Johnson & Johnson e-mails and statements detailing the relationship with Omnicare. The government claims that those documents show that Johnson & Johnson came to see Omnicare pharmacists as an extension of its sales force.

Prosecutors allege that Johnson & Johnson’s conduct caused false or fraudulent claims to be filed with Medicaid, the public health program for the poor and disabled.

Double Vision Possible Fluoroquinolone Side Effect

Wed, 09 Sep 2009 00:00:00 -0400

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.

Levaquin Litigation Moving Ahead

Mon, 06 Jul 2009 00:00:00 -0400

Because of the many lawsuits involved over Johnson & Johnson’s antibiotic Levaquin, the cases have been deemed a mass tort and assigned to an Atlantic County, New Jersey, judge, reports Law.com. Levaquin is prescribed for bacterial infections of the lungs, urinary tract, and skin. Levaquin is made by Johnson & Johnson subsidiary Ortho-McNeil Pharmaceutical Inc., and received U.S Food and Drug Administration (FDA) approval in 1996 noted Law.com

The lawsuits, which we recently reported as having begun to circulate through the courts, allege that Levaquin has caused Achilles' tendon ruptures and other damage. Just over a year ago, federal regulators ordered that Levaquin and similar antibiotics bear Black Box warnings about their association with serious tendon injuries.

In May we wrote that most litigation specialists expected thousands of people to file lawsuits against the makers of Levaquin and similar drugs. Last June, federal Levaquin lawsuits were consolidated in Multi-District Litigation before U.S. District Judge John R. Tunheim in the District of Minnesota.

Recently, attorneys representing Levaquin victims in New Jersey state court requested that those lawsuits be centralized before one judge, as well. Now, according to Law.com, that mass-tort status is expected to encompass thousands of cases against the same defendants arguing similar “complex issues of law and fact,” with patients alleging similar damages and injuries, said Law.com.

When the FDA required that the labeling of Levaquin and other fluoroquinolone antibiotics be revised to include a Black Box warning about tendon injuries in 2008, the FDA database showed 262 reported cases of tendon ruptures, 259 cases of tendonitis, and 274 cases of other tendon disorders associated with these drugs. The majority of tendon ruptures—61 percent—were tied to Levaquin.

At the time, the FDA warned that pain, swelling, inflammation, and tears of tendons including the Achilles, shoulder, hand, or other areas can happen in patients taking Levaquin. The agency said such injuries were more likely to occur in people who are over 60 years of age, taking steroids (corticosteroids), or who have undergone a kidney, heart, or lung transplant. The most common tendon injury associated with Levaquin involves the Achilles tendon.

In some cases, Levaquin tendon ruptures have required surgical repair, and victims have needed to undergo extensive rehab. Tendon rupture can occur during or after completion of a course of Levaquin, although cases occurring up to several months after completion of therapy have been reported.

New York law firm, Parker, Waichman & is among the firms that have filed Levaquin lawsuits in New Jersey.

According to a prior Wall Street Journal report, one of the latest Levaquin lawsuits filed in a New Jersey state court on behalf of three plaintiffs from around the U.S. charged that Johnson & Johnson and Ortho-McNeil represented Levaquin as a safe antibiotic despite its known association with tendon damage. The attorney representing the three Levaquin plaintiffs also pointed out that the drug is far more expensive than generic alternatives that have better safety profiles, the Journal said.

Free Antibiotics Programs Criticized

Fri, 06 Mar 2009 00:00:00 -0500

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 -0500

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 -0500

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.

FDA To Seek Black-Box Warning On Cipro and Levaquin

Tue, 08 Jul 2008 00:00:00 -0400

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 -0500

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 -0400

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."

Levaquin Side Effects, Lawsuits, Stevens Johnson Syndrome | Tendon Injuries, Ruptures, Skin Disorder

Sun, 15 Aug 2004 00:00:00 -0400

Levaquin Side Effects May Lead To Stevens Johnson Syndrome Lawsuits

Levaquin | Lawyers, Lawsuits | Side Effects: Tendon Ruptures, Tendon Injuries, Stevens Johnson Syndrome

Levaquin, an antibiotic sold by Johnson & Johnson and Ortho-McNeil, has been linked to hundreds of cases of serious tendon injuries and tendon ruptures, as well as a serious skin disorder called Stevens-Johnson Syndrome. Parker, Waichman, LLP attorneys are currently offering free Levaquin lawsuit evaluations to anyone injured by this medication. While the association between Levaquin and these serious side effects has been known for many years, Johnson & Johnson and Ortho-McNeil have represented this drug as a safe antibiotic. In fact, the companies have continued to do so even though it is known that many other antibiotics are far safer - and just as effective - as Levaquin.

In 2008, the Food & Drug Administration (FDA) finally forced Johnson & Johnson and Ortho-McNeil to place a strong Black Box warning on the label of Levaquin regarding its link to tendon damage, especially ruptures of the Achilles tendon. But this warning came too late for scores of people. Because the companies did not adequately warn patients and their doctors about these potential Levaquin side effects, thousands of people needlessly suffered debilitating injuries. In many instances, Levaquin tendon ruptures have required victims to undergo surgery and extensive rehab. Even following such treatment, many Levaquin users never completely recover from their tendon injuries.

The personal injury lawyers at Parker Waichman, LLP are currently representing people suffering because of this defective antibiotic, and many Levaquin lawsuits are pending in courts throughout the country. If you or someone you know experienced a tendon injury or tendon rupture, or suffered from Stevens-Johnson Syndrome during or following treatment with Levaquin, we urge you to contact our Levaquin tendon injury lawyers right away to protect your legal rights.

Levaquin Tendon Injuries

Levaquin was approved by the FDA in 1996. Levaquin is a member of the fluoroquinolone family of antibiotics - a subset of quinolone drugs. It is prescribed to treat bacterial infections of the lungs, urinary tract and skin.

Levaquin is an expensive antibiotic.

A full course of treatment can cost as much as $100. In fact, there are many other antibiotics - including some generics - that cost patients far less, and are much safer, than Levaquin. Yet through their marketing efforts, Johnson & Johnson and Ortho-McNeil persuaded doctors that Levaquin offered patients some advantage over less-costly alternatives. In light of its serious side effects, few people continue to believe the benefits of Levaquin outweigh its risks.

If you are taking Levaquin, you need to be aware that tendon ruptures and other tendon injuries are associated with this drug. You should seek immediate medical attention if you experience any of the following:

a snap or pop in a tendon area
bruising right after an injury in a tendon area
the inability to move the affected area or bear weight
pain, swelling, or inflammation in a tendon area

You should also know that Levaquin tendon injuries are more likely to occur in people who are over 60 years of age, taking steroids (corticosteroids), or who have undergone a kidney, heart, or lung transplant. The most common tendon injury associated with Levaquin involves the Achilles tendon. A rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, and the thumb have also been reported. Tendon rupture can occur during or after completion of a course of Levaquin, although cases occurring up to several months after completion of therapy have been reported.

Levaquin Black Box Warning

All fluoroquinolone antibiotics have been linked to serious tendon ruptures, but Levaquin is the one most commonly associated with this side effect. By 2008, the FDA's database showed 262 reported cases of tendon ruptures, 259 cases of tendinitis, and 274 cases of other tendon disorders associated with these drugs. The majority of tendon ruptures - 61 percent - were tied to Levaquin.

Many patient advocates spent years pushing for stronger Levaquin warnings. In August 2006, the consumer advocacy group Public Citizen and the Illinois Attorney General petitioned the FDA to add a Black Box warning to Levaquin's packaging. The petition also asked the agency to require that patients be given FDA-approved medication guides that would also warn of tendon ruptures associated with the drug.

In July 2008, the FDA finally directed Johnson & Johnson and Ortho-McNeil to add a Black Box warning - the agency's most serious safety alert - to Levaquin's label regarding its association with tendon damage. According to the FDA, pain, swelling, inflammation, and tears of tendons including the Achilles, shoulder, hand, or others can happen in patients taking Levaquin.

Stevens-Johnson Syndrome

Stevens-Johnson Syndrome and toxic epidermal necrosis (TEN) are life-threatening skin conditions that have also been associated with Levaquin. Both of these disorders are often caused by severe reactions to drugs. Stevens-Johnson Syndrome and TEN can start with mild non-specific symptoms such as fever, malaise, chills, aching muscles, headache, sore throat or stinging eyes.

In Stevens-Johnson Syndrome, a person has blistering of mucous membranes, typically in the mouth, eyes, and vagina, and patchy areas of rash. With TEN, which is a more severe form of Stevens-Johnson Syndrome, there is a similar blistering of mucous membranes. However, in addition to blistering, the entire epidermis peels off in sheets from large areas of the body.

The mortality rate for persons suffering with Stevens-Johnson Syndrome is between 25-80%. Some of the factors that determine a person's likelihood of survival include the severity of the disorder and the amount of skin that the victim looses. If a person with Stevens -Johnson Syndrome has lesions that are exposed and become infected, they have a much higher chance of death.

To save the life of a person with Stevens-Johnson Syndrome or TEN, treatments usually include antibiotics, intravenous immunoglobulin (IVIG), pain medication, and, in the most severe cases, skin grafts.

Because Stevens-Johnson Syndrome and TEN are so dangerous, Levaquin patients and their caregivers must be aware of their symptoms so they know when to seek medical attention. It is important to seek medical care and discontinue use of Levaquin if these disorders develop.

Levaquin Side Effects Injury Lawsuit

Our Levaquin injury lawyers believe that Johnson & Johnson and Ortho-McNeil waited far too long to issue adequate warnings about this drug's association with tendon damage. As a result, potentially thousands of people were needlessly put at risk for debilitating tendon injuries. This negligence is particularly galling, considering there are many safer alternatives to Levaquin.

Legal Help For Victims Affected By Levaquin

If you or someone you love has used Levaquin and suffered a tendon rupture or other tendon injury, you may be eligible to file a Levaquin lawsuit.

We are also offering free case evaluations for anyone who developed Stevens-Johnson Syndrome while taking Levaquin. Please fill out our online form or call 1-800-LAW-INFO (1-800-529-4636) as soon as possible to discuss your case with one of our Levaquin injury lawyers today.