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Tequin’s Serious Injuries – Bristol-Myers Feigns Ignorance

Evelyn Pringle April 26, 2006

On April 27, 2006, Dow Jones reported that Bristol-Myers Squibb had decided to stop selling Tequin, an antibiotic found to increase the risk of blood-sugar problems.

BMS made a “recent decision to stop all our commercialization efforts” for Tequin and to return the rights to Kyorin, Dow quoted Chief Financial Officer, Andrew Bonfield, as saying.

BMS licensed the drug from Kyorin Pharmaceutical of Japan in 1996 and obtained FDA approval sell the drug in the US in December 1999.

A much more believable explanation for pulling Tequin off the market is that BMS is anticipating the filing of an infinite number of lawsuits against the company in the near future so it figured it was a good idea to get out of Dodge.

Tequin, (Gatifloxacin) belongs to the class of antibiotics known as fluoroquinolones, typically used to treat lung, sinus and urinary tract infections and certain sexually transmitted diseases.

This class of drugs has a long history of serious side effects. In fact, the following fluoroquinolones are either under use restriction, or have been removed from the market: (1) temafloxacin due to red blood cell damage, kidney failure and hypoglycemia; (2) grepafloxacin because of heart problems; and (3) trovafloxacin due to liver damage.

If BMS is to be believed, it was not aware of any serious side effects associated with Tequin when it was approved for use in the US. In a September 20, 2000 press release, the company announced that in the first 6 months, Tequin had been prescribed for more than 500,000 patients in the US within 6 months after it was approved by the FDA on December 17, 1999.

It bragged that Tequin was the first quinolone antibiotic to achieve this milestone during the first 6 months on the market, citing audited data reported in June, 2000, by IMS Health, a supplier of market research to the pharmaceutical industry

By September 2000, the press release said, Tequin had been prescribed to more than 800,000 patients in the US and more than 1 million patients worldwide.

And as a result, company profits skyrocketed. According to Bristol’s 2004 Annual Report, in 2003, sales of Tequin increased by 13% to $208 million, up from $184 million in 2002.

In September 20, press release, BMS said the most common side effects associated with Tequin in clinical trials were gastrointestinal and adverse reactions “considered to be drug related and occurring in greater than or equal to three percent were: nausea (8%), vaginitis (6%), diarrhea (4%), headache (3%) and dizziness (3%).”

In a January 28, 2000, press release, the company said Tequin “has been shown in clinical trials to provide excellent efficacy and tolerability.”

Not a peep was heard about the serious adverse reactions that have since been revealed.

However, BMS has been aware of most of Tequin’s side effects for years. For instance, an article about the glucose disorders associated with the drug was published by Health Canada in the Canadian Adverse Reaction Newsletter in July 2003.

The article discussed a postmarketing study on the use of Gatifloxacin with more than 15,000 patients and reported the incidence of hypoglycemic events as 0.3 per 1000 among nondiabetic patients and 6.4 per 1000 in patients who were diabetic.

The rate of hyperglycemia found in the study was 0.07 per 1000 in nondiabetics, and 13 per 1000 in diabetic patients.

By 2002, Health Canada’s database of spontaneous reports of adverse reactions indicated that hypoglycemia and hyperglycemia had been reported more frequently with gatifloxacin than with any other quinolone antibiotics, according to Parilo MA. Gatifloxacin-associated hypoglycemia, J Pharm Technol 2002;18:319-20.

Health Canada received 28 reports of abnormal glucose metabolism associated with Gatifloxacin (44% of total reports received for the drug) from February 21, 2001 (date marketed in Canada), to February 28, 2003: 19 were for hypoglycemia, 7 were reported hyperglycemia, and 2 involved both hypoglycemia and hyperglycemia.

Twenty-five of the cases involved patients with type 2 diabetes, 2 involved nondiabetic patients, and in 1 case the patient’s diabetic status was unknown.

Of the 28 cases, 19 of the patients were admitted to hospital or had a prolonged hospital stay because of the reaction. The 2 patients who died had hyperglycemia, and had no prior history of diabetes or decreased renal function at the time of the reaction.

The Canadian product monograph for Tequin was updated in December 2002, in response to the reported cases of serious, life-threatening disturbances of glucose homeostasis.

In December 2005, Health Canada, citing evidence indicating of glucose disorders, asked BMS to submit revised product information for Tequin. BMS submitted information for review, but Health Canada noted that given the availability of other antibiotics, patients with diabetes should be prescribed alternative antibiotics while the agency was reviewing the data.

Also in December 2005, according to Health Canada, BMS issued a letter to Canadian health care providers and a public health advisory about a possible link between the antibiotic and blood glucose disorders, after serious cases of both low blood sugar and high blood sugar were reported in patients worldwide.

In February 2006, the FDA finally entered the fray and joined Health Canada in announcing that BMS had informed doctors that Tequin should not be used with diabetics, and that elderly patients, as well as those with kidney problems, were more likely to experience serious side effects.

Also in February, BMS revised Tequin’s label in the US to warn of the potential fatal risks of high and low blood-sugar levels and recommended against the use of the drug by diabetics.

The changes were said to be made in response to the results of 2 studies conducted by a team of Canadian scientists from the Institute of Clinical Evaluative Sciences, published in the New England Journal of Medicine.

The first study involved 788 patients over the age of 66, who received treatments for hypoglycemia within 30 days after antibiotic therapy, and the second involved 470 patients in the same age group who were treated for hyperglycemia within 30 days after antibiotic therapy.

When compared to other antibiotics, the use of Tequin was found to be linked to a 4.3 times greater risk of hypoglycemia, and a 16.7 times higher risk of hyperglycemia. The increased risks were present in both diabetic and non-diabetic patients.

BMS and the FDA feigned shock over these findings but in reality, the numbers were not that much higher than those reported above by Health Canada in 2002.

Experts say Tequin patients should be alerted to the signs of blood sugar problems which can include:

Confusion
Visual disturbances
Heart palpitations
Tremors
Frequent urination
Increased thirst
Dry mouth

Back in December 2001, other serious long-term side effects associated with fluoroquinolones were reported by, Dr Jay Cohen, MD, President and Executive Director of the Center for the Prevention of Medication Side Effects, in a study published in the Annals of Pharmachotherapy.

In his study, Dr Cohen found that severe reactions were occurring in young, healthy, and active patients, who often were receiving antibiotic therapy for mild infections such as sinusitis, urinary tract or prostate infections.

In most cases, Dr Cohen noted, side effects were multiple, involving many systems of the body including reports that nervous system symptoms occurred in 91% of the patients, musculoskeletal in 73%, sensory system in 42% of the subjects, cardiovascular symptoms in 36%, skin reactions in 29%, and gastrointestinal symptoms in 18% of the patients.

The fluoroquinolone class of antibiotics includes: ciprofloxacin (Arflox, C-Flox, Ciloxan, Ciloquin, Ciproxin, Ciprol, Profloxin, Proquin, Procip, Ciprobay, Ciaxone); norfloxacin (Insensye, Norflohexal, Noroxin, Nufloxib, Roxin); gatifloxacin (Tequin); moxifloxacin (Avelox); as well as several other generic versions of ciprofloxacin and norfloxacin.

Another serious side effect experienced by patients using Tequin involves tendon disorders. A February 2006, Australian Adverse Drug Reaction Bulletin, reported an increased risk of tendinitis and even tendon rupture with all fluoroquinolones.

Of the 213 reported cases of tendinitis or tendon rupture, more than 80% involved fluroquinolones, the Bulletin said.

“Patients should be advised to be alert for pain or discomfort in the Achilles tendon or calf,” the Bulletin warned, “and to inform their doctors and cease taking the medicine if this occurs.”

In September 2004, the FDA announced label changes for Tequin to include warnings of (1) QTc Interval Prolongation; (2) Tendon Effects; and (3) Peripheral Neuropathy and added descriptions of these 3 adverse reaction to the patient package inserts.

For QTc interval prolongation, the insert states: “Gatifloxacin has the potential to prolong the QTc interval of the electrocardiogram in some patients. QTc prolongation may lead to an increased risk for ventricular arrhythmias including torsades de pointes.”

On peripheral neuropathy, the insert notes: “Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving quinolones.”

And for tendon effects, the insert states: “Ruptures of the shoulder, hand, Achilles tendon, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including levofloxacin.”

In light of the serious injuries now linked to the drug, it might have been a wise decision on the part of BMS to get Tequin out of Dodge.

Filed under: 2006, Bristol-Myers, Tequin

Tequin – Blood-Sugar Problems Ain’t All

Evelyn Pringle March 17, 2006

The antibiotic, Tequin, manufactured by Bristol Myers Squibb, has been linked to both hypoglycemia and hyperglycemia by researchers who examined treatment outcomes associated with various antibiotics in approximately 1.4 million patients, 66 years of age and older, between April 2002 and March 2004.

A team of Canadian scientists from the Institute of Clinical Evaluative Sciences, recently reported the results of their study in the New England Journal of Medicine.

Worldwide, Tequin (gatifloxacin) is a commonly used drug. In 2004, over 30 companies were marketing the antibiotic under brand names like Gaticin, Gatilox, Gatiquin, Gatoxc and Microgat. The Canadian scientists reported that on an average, Tequin is prescribed about 500 times a day in Canada.

Tequin is a member of the class of antibiotics called fluoroquinolones. According to the Mayo Clinic web site, the drug is used to treat many different bacterial infections including pneumonia, bronchitis, sinus infections, respiratory tract infections, urinary tract infections and certain sexually transmitted diseases. Some of the other antibiotics in this class include Cipro (ciprofloxacin), Floxin (ofloxacin), and Levaquin (levofloxacin).

The Canadian findings were the result of two population-based, case-control studies. For each patient, the researchers identified up to 5 controls matched according to sex, age, the presence or absence of diabetes, and the timing of antibiotic treatment.

In the first study, 788 patients were identified who had been treated in the hospital for hypoglycemia (low blood sugar) within 30 days of receiving outpatient treatment with either a macrolide, a second-generation cephalosporin antibiotic, or a respiratory fluoroquinolone antibiotic (gatifloxacin, levofloxacin, moxifloxacin, or ciprofloxacin).

The use of Tequin was linked with a 4.3 times higher risk of hypoglycemia and a small increased risk of low blood sugar was also found with Levaquin. There was no increased risk shown with any of the other antibiotics examined.

In the second study, 470 patients were identified who received hospital care for hyperglycemia (high blood sugar) within 30 days after antibiotic therapy. When compared with macrolides, Tequin was associated with a 16.7 times higher risk of hyperglycemia, while no risk was noted with the other antibiotics.

Within the groups, there were 61 Tequin recipients with hypoglycemia and 86 with hyperglycemia. Overall, one of every 100 patients who took the drug was hospitalized.

The increased risks were similar in both groups of patients regardless of the previous presence or absence of diabetes.

“As compared with the use of other broad-spectrum oral antibiotics, including other fluoroquinolones,” the study concluded, “the use of gatifloxacin among outpatients is associated with an increased risk of in-hospital treatment for both hypoglycemia and hyperglycemia.”

The importance of these findings prompted the New England Journal of Medicine to make the study available online nearly a month in advance of its regular publication date of March 30, 2006. Changes in blood sugar levels can induce coma and other serious problems, including death.

The Mayo Clinic say patients taking Tequin need to be aware of the signs and symptoms of blood sugar fluctuations which include:

Confusion
Visual disturbances
Heart palpitations
Tremors
Frequent urination
Increased thirst
Dry mouth

In February 2006, Health Canada and the FDA issued advisory statements that said Bristol-Myers had told doctors that Tequin should not be used with diabetics, and that patients with kidney problems were more likely to experience serious side effects from the drug. The public health agencies also announced label changes for Tequin to include stronger warnings about the drug’s link to blood-sugar related problems.

The editorial, “Serious Adverse Drug Effects – Seeing the Trees through the Forest,” by Dr Jerry Gurwitz from the Meyers Primary Care Institute in Worcester, MA appears with the NEJM online study and says the FDA should consider mandating a “black-box” warning for Tequin’s label or package insert.

“For every approved indication for [Tequin], there are safer, equally effective and less costly alternatives,” Dr Gurwitz wrote in the editorial.

However, Dr David Juurlink, one of the Canadian researchers involved in the study, does not believe stronger warning labels are enough. He urges doctors not to prescribe Tequin at all.

“There are multiple alternatives,” he says, “that are just as good and do not have this set of side effects that is unpredictable and potentially life threatening,” according to the March 2, 2006 Wall Street Journal.

The actual number of blood-sugar risks are estimated to be much higher than listed in the study. Dr Juurlink was quoted by Reuters on March 1, 2006 as saying: “We can’t identify everybody, only those who survived [a seizure from low blood sugar and made it] to the hospital or those sick enough to go to the hospital.”

“If they died at home or in a pre-hospital setting, they would not have made it into the study,” he said in the March 2, 2006 LA Times.

In the US, Tequin labeling has repeatedly changed over time based on other reports indicating that the antibiotic could dramatically alter blood sugar levels.

It came on the market in 1999, and by 2001, 3.3 million prescriptions per year were being written for the drug. Researchers began noticing problems that year, particularly alterations in glucose metabolism, according to the Times.

By 2003, 17 deaths had been linked to Tequin and prescriptions dropped to about 1.7 million per year.

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

The government also chose Tequin because its risk of glucose abnormalities did not seem to be any higher than other antibiotics in the class, Dr Juurlink said. In light of the new findings, he told the Times, “the VA needs to very promptly revisit their policy.”

Other adverse effects have also contributed to the withdrawal or restriction of several other drugs in this class of antibiotics including kidney failure and liver problems, according to the Mayo Clinic web site.

In addition, a wide range of neurological adverse effects linked to the fluoroquinolone antibiotics, reportedly found to occur in as many as 7% of patients, are described in a medical study conducted in 2001. These side effect symptoms include pins and needles, numbness, tingling, muscle and joint pain, palpitations, malaise, panic attacks, and anxiety, according to the study, “Peripheral Neuropathy Associated with Fluoroquinolones,” by Jay S. Cohen, MD, in the December 2001, issue of The Annals of Pharmacotherapy, Volume 35.

Dr Cohen, President and Executive Director of the Center for the Prevention of Medication Side Effects, authored the study on long-term reactions to fluoroquinolones and the results were pre-released in October 2001, during the anthrax scare when Cipro was being widely prescribed without proper warnings to patients.

Within days of the publication, Dr Cohen says the CDC changed their guidelines and listed doxycycline and penicillin antibiotics as the preferred treatment for anthrax exposure before Cipro.

Doxycycline and penicillin were associated with much fewer serious side effects than fluoroquinolones, and were not linked to the disabling and long-term reactions identified in the study.

In most cases, he says side effects were multiple and involved many systems of the body.

The study found nervous system symptoms occurred in 91% of the patients, sensory system symptoms in 42%, musculoskeletal side effects in 73%, cardiovascular adverse effects in 36%, skin reactions in 29%, and gastrointestinal symptoms in 18% of the patients.

Dr Cohen found it especially alarming that severe reactions were occurring in patients who were young, healthy, and active, and most often were receiving antibiotic treatment for mild infections such as sinusitis, urinary or prostate infections. Most reactions occurred quickly, sometimes with just a few doses of the antibiotic.

For example, a male patient, age 36, previously in good health, ended up with chronic, debilitating multi-focal neuropathy, fibromyalgia, chronic fatigue, gastrointestinal problems, heart arrhythmia requiring pacemaker, carpal tunnel syndrome, chronic multiple joint pains, and chronic pain. Five years later at age 41, the patient was still disabled.

A previously healthy 32-year-old female patient was treated for a urinary infection and after 5 days, developed pain in wrists, neck, back, knees, hips, elbows, shoulders, and Achilles tendons.

A 34-year-old healthy male, was treated for a prostate infection and experienced side effects that included muscle spasms and twitching, numbness, impaired coordination, weakness, increased sensitivity to temperatures, fatigue, multiple joint, muscle pain, palpitations, and blurred vision for more than 1 year.

A 47-year-old female patient who was previously in good health, sought treatment for sinusitis and within 2 days of taking the antibiotic, developed severe joint pain in her hands, insomnia, severe agitation, weakness, dizziness, severe fatigue, mental infusion, abnormal dreams, and gastrointestinal symptoms, with many of the adverse effects listed as still severe after 7 months.

Another woman aged 49, with previous good health, received antibiotics for a pelvic infection that resulted in burning pain, memory loss, joint pains, palpitations, nerve pain, insomnia, abnormal sense of smell, tinnitis, and panic attacks for a duration of more than 3 years.

Another 35-year-old male, in good health, received treatment for a prostate infection and after one dose of medication he experienced ringing in the ears and peripheral nerve symptoms that lasted 2 weeks. He then developed tendonitis in his shoulders, elbows, wrists, hands, and Achilles tendons, with burning pain and tightness in his calves. This man was still unable to walk more than a short distance 2 months later.

“Prior to taking the medication I asked about side effects and was told there were none for adults except an upset stomach,” this patient told Dr Cohen. “Afterwards I was told that what I was experiencing could not be related to the drug,” he said.

Denying the link between the adverse events and the fluoroquinolones is apparently common. “In most cases,” Dr Cohen says, “their doctors have dismissed their complaints or outright deny that the reactions could occur with fluoroquinolones.”

“Yet extensive medical workups do not find any other cause,” he reports.

“Worse, there are no known effective treatments,” he says. “Thus, these people suffer pain and disability for weeks, months, years.”

“Overall, my sense is that these reactions are not rare,” Dr Cohen advises.

“Patients have a right of informed consent, and this includes warnings of potential serious, disabling reactions,” he notes.

“Most of all,” he warns, “we must educate doctors to avoid prescribing fluoroquinolones for minor infections, instead saving them for serious infections, just as we do with other groups of antibiotics with serious toxicities.”

In the January 8, 2002 article titled, “Side Effects of Quinolone Antibiotics Like Tequin (Gatifloxacin) Can Be Serious,” Mary Shomen gives a first-hand account of how varied and frightening some of the Tequin side effects can be.

Ms Shomen was prescribed Tequin for a sinus infection at an urgent care clinic and within one day experienced dizziness, tingling in her hands and knees, pain in her legs, and weakness in her arms and legs. A day later she says shortness of breath set in.

“I thought my symptoms might be related to my sinus infection,” she wrote, “until I realized that they went away at night, and would start up again about an hour after taking my morning Tequin pill.”

After four days Ms Shomen said, “I started having worsening shortening of breath, and difficulty swallowing, so I took two Beneadryl and called the doctor.”

The call to the doctor resulted in a trip to the emergency room to see whether she was having a life-threatening allergic reaction to Tequin. At the hospital they discovered her airways were swollen so she was instructed to stay on Benadryl for 2 days.

“In the meantime,” Ms Shomen recounts, “the tingling, numbness, difficulty swallowing and other neurological symptoms continued.”

Four days later she says her memory was shot and she was still experiencing the tingling, numbness and dizziness. “After a night-time emergency call to my regular physician,” she notes, “she suggested that I take some clonazepam (Klonopin), a mild tranquilizer, to see if that could calm down the overreactive nervous system.”

The Klonopin calmed the symptoms and the doctor recommended that she remain on the drug until the side effects fully subsided.

“What I had was a dangerous – and even potentially life-threatening – drug reaction,” Ms Shomen explains. “Who knows what might have happened had I not taken the Benadryl – an antihistimine – when the shortness of breath and airway constriction began?”

On March 1, 2006, Reuters reported that Bristol-Myers spokesman, Eric Miller said the company had decided to stop actively marketing Tequin, although his comments seemed to imply that the decision was based on economics rather than safety concerns.

Mr Miller noted that although Tequin was introduced onto the market in 1999, it only generated $150 million in sales for Bristol-Myers in 2005.

However, Bristol-Meyers choices related to the sale of Tequin may be limited. According to the editorial accompanying the study in the online NEJM. “It seems clear that the drug’s place among broad-spectrum antibiotics available for outpatient use is tenuous at best.”

Filed under: 2006, Bristol-Myers, prices, Tequin

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