Yourlawyer.com (Tequin 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.

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.

Tequin Patient Develops Severe Diabetes, Sues Bristol-Meyers Squibb

Wed, 01 Aug 2007 00:00:00 -0700

A Missouri man who took the antibiotic Tequin is suing Bristol-Meyers Squibb and Schering Corporation for blood sugar problems he developed while taking the drug. Patrick Bills alleges that he developed both hyperglycemia and new onset diabetes while taking Tequin for a skin infection.

Tequin, a once-popular antibiotic, was introduced by Bristol Myers Squibb in 1999 to treat bacterial infections like pneumonia, bronchitis, urinary tract infections and sinusitis. By 2001, 3.3 million prescriptions were being written every year in the US for Tequin. It was that same year that researchers began noticing that Tequin could play havoc with blood sugar levels. Between April 2002 and March 2004, researchers at St. Michaels Hospital in Toronto followed 1.4 million patients aged 66 years and older. The researches found that 788 of those patients had to be treated for dangerously low or high blood sugar within 30 days of Tequin therapy. The research found that there was a four times greater risk of life-threatening blood sugar problems among patients treated with Tequin. When the Canadian study was published in the New England Journal of Medicine in 2006, it found that previously-healthy Tequin users had a 17-percent higher chance of developing serious diabetes.

According to a press release issued by his attorneys, Bills began taking Tequin in 2005 for a skin infection. Shortly after, he began experiencing symptoms like extreme thirst, frequent urination and vision changes. In January 2006, Bills was diagnosed with sever hyperglycemia and diabetes. The lawsuit contends that Bills’ illnesses are a direct result of his treatment with Tequin. The suit claims that before taking the antibiotic, Bills had been healthy, and had not experienced any symptoms related to blood sugar problems.

The lawsuit alleges that Bristol-Meyers Squibb ignored mounting evidence of blood sugar problems related to Tequin. It wasn’t until February 2006 that, under pressure from the Food and Drug Administration, the company added a warning label that Tequin should not be taken by diabetics. But the company did not address potential problems for non-diabetics. In May 2006, Bristol-Meyers Squibb announced to its shareholders that it was taking Tequin off the market. Bills’ lawsuit charges that this move was made with little public fanfare, and that Tequin that had already been shipped was allowed to remain on pharmacy shelves. The complaint also alleges that physicians were not given adequate warning by the company and continued to write prescriptions for Tequin.

The lawsuit lists nine different counts against the pharmaceutical company and is seeking both compensatory and punitive damages for Bills.

FDA Asked to Ban Antibiotic Tequin

Tue, 02 May 2006 00:00:00 -0700

Public Citizen has petitioned the U.S. Food and Drug Administration (FDA) to ban the antibiotic Tequin because it is linked to blood sugar abnormalities and has caused deaths and hospitalizations.

The drug, made by Bristol-Myers Squibb and approved for use in the United States in December 1999, has been linked to severe cases of low blood sugar and high blood sugar. The company is withdrawing the drug but thousands of doses remain in the supply chain.

The drug is used to treat chronic bronchitis, acute sinusitis, pneumonia, urinary tract infection and gonorrhea. In 2005, 1.2 million prescriptions for the drug were filled.

According to Public Citizen's analysis of adverse events reported to the FDA, 388 patients had dangerously low or high blood sugar as a result of taking Tequin between Jan. 1, 2000, and June 30, 2005. Of those, 20 people died and 159 were hospitalized.

Changes made to the label to warn patients about the dangers of the drugs are insufficient, said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.

More than half a dozen other antibiotics exist to treat these conditions and all are safer than Tequin.

Bristol-Myers Squibb's quiet announcement last Friday that it would no longer manufacture Tequin for economic reasons is similarly inadequate to protect the public's health since the company apparently has no intention, absent FDA action to ban the drug, to stop selling the large amount of Tequin already in the channels of commerce. Thus, without an FDA ban, thousands of additional patients will be prescribed this unacceptably dangerous drug, Wolfe said.

In addition to the adverse events associated with Tequin that were reported to the FDA, a study published on March 1 in The New England Journal of Medicine showed that patients receiving Tequin had approximately 17 times the odds of having dangerously high blood sugar and four times the odds of having dangerously low blood sugar compared to those taking other antibiotics.

In addition, such blood sugar abnormalities have been noted in clinical trials, post-marketing surveillance studies, case reports and other studies.

"This drug carries unique risk but has no unique benefits and therefore should not be on the market," Wolfe said.

If Tequin is banned, it will be the fifth drug of 13 approved quinolone antibiotics to be taken off the market because of serious safety problems.

Company abandons antibiotic linked to blood sugar problems

Tue, 02 May 2006 00:00:00 -0700

An antibiotic linked to serious blood-sugar complications has been pulled from the market in Canada and the U.S.

Bristol-Myers Squibb Co. said Tuesday it will no longer make or sell the antibiotic Tequin, also known as gatifloxacin.
The antibiotic Tequin treats infections in the respiratory and urinary tracts, bladder infections, and sexually transmitted diseases.

However, current stocks of the drug are not being recalled, a spokesman for Bristol-Myers Squibb said.

Anyone taking the drug shouldn't discontinue the treatment until they talk to a doctor about an alternative, Eric Miller advised.

The company made the decision because of marketing reasons, added Marc Osborne, director of public relations for Bristol-Myers Squibb Co. in Montreal.

People over age 65 taking Tequin showed more than a four-fold increase in the risk of being treated in hospital for low blood sugar compared with people who were on an older class of antibiotics, Canadian researchers reported in the New England Journal of Medicine in March.

Tequin is used to treat respiratory infections, urinary tract and bladder infections, and sexually transmitted diseases.

The U.S. Food and Drug Administration had required stronger warnings on the drug's label. Health Canada also issued warnings about its potential side-effects in people with diabetes.

The company has warned the antibiotic should not be used by diabetics, and noted the elderly and people with kidney disease are more prone to complications.

Health Canada is aware of the company's announcement, a spokesman for the department said.

The Canadian regulator has recommended alternative antibiotics for people with diabetes, and asked for more safety data on Tequin to update warnings on the product.

On Monday, the U.S. public interest group Public Citizen petitioned the FDA to order a recall of Tequin.

In its petition, the group said that since June 1, 2000, 388 patients have been affected by blood-sugar irregularities associated with the drug. That figure included 20 deaths and 159 hospitalizations.

Drug Company Taking Tequin Off Market

Mon, 01 May 2006 00:00:00 -0700

An antibiotic plagued by serious blood-sugar complications is coming off the market.

Bristol-Myers Squibb confirmed Monday that it plans to stop making and selling Tequin.

Spokesman Eric Miller said the company will return rights to the drug to Kyorin Pharmaceutical Company in Japan. He said the company acted after an evaluation of the product as well as ongoing transition in the company's focus.

Approved for sale in 1999, Tequin has faced questions about its effects on blood sugar, being associated with both high- and low-blood sugar in some patients.

In February the Food and Drug Administration required increased warnings on the label of the drug. The manufacturer has warned that it should not be used by diabetics and said the elderly and those with kidney disease are more likely to have problems.

Miller said that while Bristol-Myers Squibb will stop making and selling the drug, stocks currently available are not being recalled. He urged people using Tequin not to discontinue it until they talk with their physician about an alternative.

A public interest group, meanwhile, petitioned the FDA on Monday for a ban on the antibiotic.

In its petition, Public Citizen said there have been 388 patients with blood-sugar irregularities associated with the drug including 20 deaths and 159 hospitalizations since Jan. 1, 2000.

Public Citizen urged the FDA to order a recall of the drug.

"This drug carries unique risk but has no unique benefits and therefore should not be on the market," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.

Tequin is prescribed for chronic bronchitis, sinusitis, pneumonia, urinary tract and other infections.

Tequin associated with hypoglycemia and hyperglycemia

Mon, 17 Apr 2006 00:00:00 -0700

The FDA ( U.S. Food and Drug Administration ) has changed labeling for Tequin ( Gatifloxacin ), an antibiotic indicated for the treatment of patients with pneumonia, bronchitis, uncomplicated gonorrhea, and various infections including infections of urinary tract, kidneys, and skin.

The labeling changes update the prescription information as a result of continued reports of serious cases of hypoglycemia and hyperglycemia in patients receiving Tequin.

Since the approval of Tequin in 1999, there have been rare cases of life-threatening events reported globally in patients treated with the drug. Most of these events were reversible when properly managed, but a few had fatal outcomes.

Prescribing information has been revised to include a Contraindication in diabetic patients due to serious reports of hypoglycemia and hyperglycemia ( dysglycemia ).

Additionally, the Warnings and Precautions sections have been updated to identify other risk factors for dysglycemia ( older age, renal insufficiency, concomitant glucose-altering medications ) while taking Tequin, and include a recommendation for close medical monitoring.

Study reveals risk to Tequin patients

Thu, 02 Mar 2006 00:00:00 -0800

Six years and 20 million patients later, a popular antibiotic has been found to cause life-threatening changes in blood glucose, according to a study.

Scientists at the Sunnybrook and Women's Science Center in Toronto have studied more than 1,260 patients hospitalized for complications from blood glucose who had received an antibiotic in the 30 days preceding their admission. They looked back to see who among them had received Tequin, the antibiotic in question. Tequin (gatifloxacin), developed by Bristol-Myers Squibb, was federally approved in 1999. About 5,000 prescriptions of the antibiotic are written each day for a variety of bacterial infections. Early on, the company reported some risk for blood-sugar problems, but it was always associated with a history of diabetes and it was not known how common the problem is.

That's why Dr. David Juurlink, a clinical pharmacologist at Sunnybrook and co-author of the study, decided to do a large controlled study to see whether patients taking Tequin were at greater risk of developing this potentially fatal side effect. And the findings, he said, were alarming.

"The problem took several years to appreciate," Juurlink said. After studying 788 patients admitted for complications from low blood sugar and 470 with high blood sugar, all of whom had been given an antibiotic before their hospitalization, the blood sugar changes seemed unique to Tequin. About 1 percent of the patients taking the antibiotic are at risk, "and it's unpredictable who will develop this complication." They found it in patients with and without diabetes.

The hospitalized patients were also compared to an age-matched sample of people who had been on a recent trial of antibiotics, but who suffered no changes in blood glucose. The results, that people on the drug were four times more likely to develop low blood pressure and 17 times more likely to develop high blood pressure than those on other antibiotics - is cause for concern, Juurlink said. The study, to be published later this month in the New England Journal of Medicine, was released early because of the seriousness of the findings.

"One percent is a significant risk, especially when 5,000 patients a day are taking this medicine," Juurlink said. "That's 50 patients a day, and that's only the ones we know about who were hospitalized."

Last month, the company alerted the Food and Drug Administration of the potential side effects, and sent letters to physicians worldwide, according to company spokesman Eric Miller. The company updated the labeling to include a warning of blood sugar changes in certain risk groups, including diabetics, older people and those with kidney problems.

Antibiotic Found to Cause Blood-Sugar Ailments in Seniors

Thu, 02 Mar 2006 00:00:00 -0800

Elderly patients taking the widely used antibiotic gatifloxacin were almost 17 times as likely to be hospitalized for very high blood sugar levels and four times as likely to be hospitalized for unusually low levels, a finding that is leading some physicians to call for the drug's withdrawal from the market.

Overall, one of every 100 patients who took the drug was hospitalized, according to a study released online Wednesday by the New England Journal of Medicine. The study was released before its March 30 publication because of its health implications.

Several previous studies have shown an increased risk of glucose abnormalities and several deaths in diabetic patients who received the antibiotic, trade-named Tequin. The drug's label was changed last month to say it should not be given to diabetics.

The latest study, which is larger and more definitive, showed that all patients were at risk, even those who were not diabetic.

The study's authors said that because other antibiotics were as effective, there was no reason to continue prescribing gatifloxacin.

"Speaking as a clinician, I would never prescribe this drug," said Dr. David N. Juurlink of the Institute for Clinical and Evaluative Sciences in Toronto, who led the study.

Dr. Sidney Wolfe of the Public Citizen Health Research Group in Washington, D.C., said: "This represents a unique danger in the absence of a unique benefit…. This is more than enough reason to think about petitioning the Food and Drug Administration to ban the drug, and we probably will."

Eric Miller, a spokesman for Bristol-Myers Squibb Co., which makes Tequin, said that the findings "were consistent with the post-marketing experience we have had to date." He said the labeling changes in February took the findings into account.

Miller said the company's annual sales of the drug were about $100 million in the United States and $150 million worldwide — a relatively minor portion of Bristol-Myers' $19.4 billion in total revenue.

Gatifloxacin is a member of the family of broad-spectrum antibiotics known as fluoroquinolones. It is typically used to treat gonorrhea and lung, sinus and urinary tract infections. Physicians often use it when the nature of an infection is unknown, Juurlink said, because it kills a wide variety of bacteria.

But the quinoline family has proved problematic. Four other fluoroquinolones have been withdrawn from the market or had their use severely restricted: temafloxacin, for causing red blood cell damage, kidney failure and hypoglycemia; grepafloxacin and sparfloxacin because of heart problems; and trovafloxacin because of liver damage.

"That is an alarming proportion of drugs in that class that have been taken off the market," said Wolfe of Public Citizen.

Gatifloxacin was introduced in 1999. By 2001, 3.3 million prescriptions per year were being written.

Researchers began noticing health problems that year, particularly alterations in glucose metabolism. Changes in blood sugar levels can induce coma and other serious problems, including death. Symptoms usually began five to 10 days after patients took the drug.

In most cases, the symptoms could be reversed when drug use was halted.

By 2003, 17 deaths had been linked to the drug and prescriptions were down to about 1.7 million per year.

One major contributor to that number is the Department of Veterans Affairs, which added the drug to its formulary and designated it an antibiotic of first choice, in part because Bristol-Myers offered the government a price of $1.35 per pill, compared with the $8 to $10 per pill charged for it and other fluoroquinolones at pharmacies, said Dr. Richard Frothingham of Duke University.

The government also chose it because the risk of glucose abnormalities caused by gatifloxacin did not seem to be any higher than that caused by other antibiotics in the class, Juurlink said.

In light of the new findings, he said, "the VA needs to very promptly revisit their policy."

The Canadian researchers studied health records for 1.4 million Ontario residents over age 65. Among them were about 17,000 gatifloxacin patients.

Juurlink and his colleagues then looked at all patients who had been hospitalized after taking an antibiotic. They found 788 were hospitalized for excessively low blood sugar within 30 days of taking an antibiotic and 470 patients hospitalized for excessively high blood sugar.

Within that group, there were 61 gatifloxacin recipients with hypoglycemia and 86 with hyperglycemia. Compared with other patients in the group, the gatifloxacin recipients had four times the risk of hypoglycemia and 17 times the risk of hyperglycemia.

"This is the most compelling evidence to date showing a connection between gatifloxacin and glucose problems," Frothingham said.

No other fluoroquinolone showed an unusual risk.

Juurlink said the study probably underestimated the risks of the drug. "If they died at home or in a pre-hospital setting, they would not have made it into the study," he said.

Tequin Diabetes Lawyer Side Effects Attorney

Thu, 02 Mar 2006 00:00:00 -0800

Suffered from Tequin Side Effects?

Tequin to be Pulled from the Market
On May 1, 2006, Bristol-Myers Squibb stated that it will cease making and selling its antibiotic Tequin. Tequin has been linked to serious cases of diabetes and other potentially fatal blood sugar abnormalities. According to a Canadian study that was supposed to appear in the New England Journal of Medicine in March, Tequin users had 17 times greater risk of developing serious diabetes and 4 times greater risk of being hospitalized with low blood sugar complications than patients using other antibiotics. Tequin (generic: gatifloxacin) received FDA approval in 1999. Consumer group Public Citizen stated that there have been 388 patients with blood-sugar irregularities linked with Tequin since January 1, 2000. Those cases included 20 deaths and 159 hospitalizations. The consumer group and various physicians called for the drug's withdrawal, claiming it carries great health risks but few benefits over similar drugs.

Canadian Study
In March, 2006 the results of a Canadian study were released which showed that Tequin was linked to serious cases of diabetes and other blood sugar disorders. These results were set to appear in the March 30, 2006 New England Journal of Medicine but were released early due to the life threatening nature of the side effects. Based on the study's alarming findings, the author, Dr. David Juurlink of the Sunnybrook and Women's College Health Sciences Center in Toronto, questioned whether the drug should be immediately removed from the market. Other prominent physicians believed that a black box warning should be added to Tequin's warning label.

Warning for Diabetics May Apply to Anyone Taking Tequin
In early 2006, Bristol Myers Squibb and the FDA added a warning to the drug's label notifying diabetics not to take Tequin. However, the study's author said the blood-sugar problem can happen to anybody whether they have diabetes or not, and it usually occurs within a few days of taking the drug. The risk of the drug might be even greater than the study revealed because it was only based on hospital data. If a patient suffered these side effects but wasn't hospitalized, or died, they would not have been included in the study data.

About Tequin
Tequin is an antibiotic that is commonly used to treat adults with lung, sinus and urinary tract infections as well as certain sexually transmitted diseases. Tequin is an antibiotic in the class of drugs called fluoroquinolones, which also contains Cipro, Levaquin and Avelox. This recent study indicates that the risk of diabetes is specific to Tequin and is not a problem with the entire class of drugs. However, the entire class of drugs has been linked to tendon ruptures. Last year Tequin had worldwide sales of $150 million, including $100 million in the United States.

Legal Help for Tequin Users
If you or a loved one took Tequin and suffered from diabetes, hyperglycemia, hypoglycemia, or other blood sugar side effects, please fill out the form at the right for a free case evaluation by a qualified defective drugs attorney.