Avandia (rosiglitazone) was approved by the FDA in 1999 for treatment of type 2 diabetes by controlling blood sugar levels. However, since May 2007, substantial concerns have emerged regarding a number of potentially fatal Avandia side effects.

The Public Citizen petition indicates that Avandia should be banned because the health risks outweigh any potential benefits it may provide. In addition to previously reported risks, like an increased risk of heart attacks, congestive heart failure, bone fractures and vision loss known as macular edema, Public Citizen pointed to new concerns about an association between Avandia and liver failure.

From a review of the FDA Adverse Event Reporting System, Public Citizen was able to identify at least 14 cases of Avandia induced liver failure, including 12 deaths.

Public Citizen is a prominent consumer advocacy group which represents over 80,000 consumers in the United States. The Health Research Group of Public Citizen has previously taken similar actions to push for regulations that protect the public against ineffective and unsafe drugs and medical devices.

In 2006, Public Citizen filed a similar petition with the FDA calling for a Black Box tendon rupture warning for Levaquin and other antibiotics belonging to a class of medications known as fluoroquinolones. However, it was not until July 2008, over two years later, that the FDA announced that they would require the manufacturers to add almost the exact same warnings that Public Citizen had requested.

Potentially hundreds of users could have suffered debilitating Levaquin tendon ruptures as a result of the drug makers’ failure to adequately warn about this risk and the FDA’s failure to act on the petition for two years.

Last year, following the emergence of concerns about the heart risks associated with Avandia, the FDA narrowly voted against an Avandia recall and allowed the drug to stay on the market with a black box warning about the risk of heart attacks and congestive heart failure.

Several experts who have advocated for a recall suggest that as many as 100,000 Avandia heart attacks could have been caused by side effects of the diabetes drug since it was first approved in 1999. With 10,000 Avandia prescriptions continuing to be filled every day, how many more people must suffer heart attacks, liver failure or death before the drug will be removed from the market?

AVANDIA RECALL LAWYERS

The Avandia lawyers at Saiontz & Kirk, P.A. represent individuals throughout the United States who are pursuing an Avandia lawsuit after suffering a heart attack, heart failure, stroke, bone fracture, blindness, liver failure or death.

If you, a friend or family member suspect that an injury may have been caused by side effects of Avandia, request a free consultation and claim evaluation.

Levaquin (levofloxacin) belongs to a group of antibiotics known as fluoroquinolones. It is manufactured by Ortho-McNeil-Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson, for treatment of prostatis and bacterial infections of the upper respiratory and urinary tracts. Other anti-microbial drugs in this class include Cipro (ciprofloxacin), Tequin (gatifloxacin), Floxin (ofloxacin), Penetrex (enoxacin), Factive (gemifloxacin), Maxaquin (lomefloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin) and Trovan (trovafloxacin).

Floxin (ofloxacin) is Levaquin’s predecessor, and the two drugs are so pharmacologically similar that the drug’s makers even indicated when they filed their New Drug Application with the FDA that Levaquin side effects would mirror those of Floxin. Therefore, they knew or should have known over 10 years ago that Levaquin would be as tendon toxic as Floxin, with an increased risk for people over 60 and those using corticosteroids at the same time.

Despite their knowledge, Johnson & Johnson introduced Levaquin in 1997 without adequate warnings about the risk of tendon damage side effects. Only a passing mention of the Levaquin tendon damage risk was made, and it was buried in the adverse reaction section.

In 2002, the warning label was updated, but they did not specify the increased risk among the elderly and used confusing language. At that time, the warning indicated that the “risk may be increased in patients receiving concomitant corticosteroids, especially the elderly.” This choice of wording seemed to indicate that elderly users of the drug who were not on corticosteroids did not have an increased risk, when the manufacturer knew that was not the case.
 
The Levaquin warning label was updated again in 2007, when the indication that the risk “may be increased” was replaced with “is increased”.

In July 2008, the FDA required that a black box warning be added prominently to the labels of all fluoroquinolone antibiotics about the tendon damage risk. They are also now requiring the makers of these drugs to provide a Medication Guide, which specifically outlines the risk of a tendon injury and the fact that immediate medical care should be sought on the first signs of tendon problems.
 
However, there is still no specific indication in the Levaquin black box warning that indicates the risk is particularly high with this drug, even when compared to other drugs in the class. While all of the antibiotics in the fluoroquinolone class contain the same language, Levaquin’swarning label should indicate that the drug is more toxic to tendons than other fluoroquinolones.

LEVAQUIN SIDE EFFECT LAWSUITS

The lawyers at Saiontz & Kirk, P.A. are investigating potential Levaquin Achilles tendon rupture lawsuits throughout the United States for injuries caused by side effects of Levaquin. If you, a friend or family member have suffered a ruptured tendon, request a free consultation and claim evaluation.

>>INFORMATION: Stevens Johnson Syndrome (SJS) Lawsuits

Stevens Johnson Syndrome, also known as SJS, is a rare but serious medical condition which is caused by an allergic reaction to several different drugs. It causes inflammation of the skin and mucous membranes, literally causing the skin to burn from the inside out. It often requires treatment in a hospital burn unit, and it is fatal in many cases.

The Children’s Motrin lawsuit was filed in the Los Angeles Supreme Court, claiming that Johnson & Johnson failed to warn about the potential Stevens Johnson Syndrome side effects. The young girl was blinded by the development of blisters and sever swelling of the eyelids. However, following a six week trial, the jury found that insufficient evidence was presented to directly link Children’s Motrin to the injury.

While many medications have been associated with SJS, some of the most commonly associated drugs are antibiotics, such as penicillin and sulfas, anti-inflammatory pain medications, such as Bextra and Celebrex, and anti-convulsants, such as Trileptal, Carbatrol, Tegretol and Equetro. SJS has also been associated with the anti-sleep medication Provigil, and the anti-smoking drug Chantix.

STEVENS JOHNSON SYNDROME ATTORNEYS

The product liability attorneys at Saiontz & Kirk, P.A. investigate potential Stevens Johnson Syndrome lawsuits throughout the United States for individuals who have developed this devastating and life-threatening condition. Many medications which could cause Stevens Johnson Syndrome, or a similar skin reaction known as Toxic Epidermal Necrolysis Syndrome (TENS), do not contain adequate warnings about the potential side effect.

If you, a friend or family member have been diagnosed with Stevens Johnson Syndrome or Toxic Epidermal Necrolysis Syndrome, request a free consultation and claim evaluation.

>>INFORMATION: Cipro and Levaquin Tendon Rupture Risk

At the time of the announcement, the FDA provided new information to healthcare providers about Levaquin and the selection of fluoroquinolone medications. The agency urged doctors to only prescribe the drugs for treatment or prevention of an infection which they strongly suspect is caused by bacteria. The antibiotics have only been approved for bacterial infections, and prescribing the drugs for viral infections, such as a common cold or the flu, could expose the user to an unnecessary risk.

Doctors have also been asked to counsel their patients about the specific risk of Levaquin tendon ruptures, especially involving the Achilles tendon which is at the back of the ankle. They should explain that tendon problems could develop, including pain, swelling, inflammation and tears, which could lead to debilitating injuries.

Although the side effects apply to all users, the risk of tendon problems from Levaquin and the other antibiotics is higher among users who are:

• Over 60 Years Old
• Taking Corticosteroids (Steroids)
• Kidney, Heart or Lung Transplant Recipients

To reduce the risk of a Levaquin tendon rupture, users are being asked to call their doctor if they experience any tendon damage, such as:

• Tendon pain, swelling or inflammation in the Achilles (heal), shoulder, hand, thumb or other tendons
• A snap or pop near a tendon
• Bruising that appears after a tendon injury
• Inability to move a joint or bear weight

If the medication is immediately stopped and medical attention is sought at the first signs of tendon problems, it is possible that a tendon rupture can be avoided. A tendon rupture is a serious injury that can leave an otherwise healthy individual incapacitated. Tendons are the tissue that connect bones and muscles, and extensive surgery is often required to treat a rupture. Following treatment, individuals who experience a tendon rupture often continue to experience significant disability, and could face a risk of a re-rupture.

LEVAQUIN TENDON RUPTURE LAWSUITS

The lawyers at Saiontz & Kirk, P.A. represent individuals throughout the United States who are pursuing a Levaquin lawsuit as a result of a tendon rupture. Potential cases are also being investigated for tendon ruptures associated with other fluoroquinolone antibiotics, such as Cipro, Proquin XR, Factive, Avelox, Noroxin and Floxin.

To review a potential claim, request a free consultation.

>>FDA LINK: Cipro and Levaquin Black Box Warning

The warnings apply to fluoroquinolone antimicrobial drugs, which are prescribed for treatment or prevention of infections caused by bacteria. The increased risk of tendon ruptures and tendon damage have been associated with the following drugs:

• Levaquin (levofloxacin)
• Cipro and generic ciprofloxacin
• Cipro XR (extended release ciprofloxacin)
• Proquin XR (extended release ciprofloxacin)
• Factive (gemifloxacin)
• Avelox (moxifloxacin)
• Noroxin (norfloxacin)
• Floxin and generic ofloxacin

PRIOR REQUESTS FOR CIPRO AND LEVAQUIN BLACK BOX WARNING

In August 2006, the consumer group Public Citizen filed a petition with the FDA requesting the black box warnings for Levaquin, Cipro and the other antibiotics, about the risk of tendon ruptures. At that time, they also urged the FDA to require that all patients receive a pamphlet with every bottle describing the risk so that users would know they should immediately stop using the drugs and contact their doctors if they experience symptoms of a tendon rupture, such as pain or inflammation.

Because the FDA failed to act on Public Citizen’s petition for two years, the consumer advocacy group filed a lawsuit against the drug regulatory agency in January 2008, alleging that their petition had been ignored. The lawsuit indicated that providing patients with more detailed information about the risks could allow them to substantially reduce the risk of a tendon rupture by discontinuing the medication if problems developed.

TENDON RUPTURE BLACK BOX WARNING

In yesterday’s announcement, the FDA indicated that a new analysis confirmed that the use of Cipro, Levaquin and other fluoroquinolone antibiotics is associated with an increased risk of tendon rupture. Although the warning labels already contained information about the possibility of tendon ruptures, large numbers of tendon problems continue to be reported, causing the FDA to finally require the “Black Box” tendon rupture warning and patient information guide.

A “Black Box” warning is the strongest warning that can be placed on a prescription medication. The new language will be placed prominently on the label in a bold black box, indicating that the drug has been associated with an increased risk of tendonitis and tendon rupture. It will also indicate that the risk could be increased among those over age 60, in kidney, heart and lung transplant patients, and with the use of concomitant steroid therapy.

The FDA has indicated that users should be urged to watch for signs of tendon pain, swelling or inflammation. Physicians have been instructed to tell their patients that if tendon problems develop they should call their doctor, stop taking the antibiotic, avoid exercise and use of the injured area. Taking these steps could help avoid an actual rupture of the tendon, which often requires surgical repair and results in permanent injury.

CIPRO AND LEVAQUIN TENDON RUPTURE LAWSUITS

The lawyers at Saiontz & Kirk, P.A. are reviewing Cipro lawsuits, Levaquin lawsuits and other legal claims for users of fluoroquinolone antimicrobial drugs who experience a tendon rupture. The problems most frequently involve the Achilles tendon, but reports of ruptures have also been seen in the shoulder, the hand, the biceps and the thumb.

To review a potential claim and determine if financial compensation may be available for a ruptured tendon, request a free consultation and claim evaluation.

>>INFORMATION: Levaquin Achilles Tendon Rupture Lawsuits

The FDA has received hundreds of reports of tendon ruptures, tendonitis and other severe forms of tendon damage after using fluoroquinolones, a class of antibioitics which Levaquin and Cipro are a part of. About 60% of the reported tendon ruptures followed the use of Levaquin and the most frequently ruptured tendon was the Achilles tendon.

Also known as the calcaneal tendon or tendocalcaneus, the Achilles tendon attaches the calf to the heel bone. An Achilles tendon rupture is a very painful injury and it often requires surgery to reattach the tendon to its normal position. Months of rehabilitation and therapy are often necessary to regain use of the ankle, and it is not uncommon for there to be ongoing tendon problems and pain even after a repair.

The lawyers at Saiontz & Kirk, P.A. are reviewing potential Levaquin and Cipro Achilles tendon rupture lawsuits. Although most of the people who have contacted our office after suffering tendon problems took either Levaquin (levoflaxacin) or Cipro (ciprofloxacin), tendon damage has also been associated with the use of other similar antibiotics, such as:

• Penetrex (enoxacin)
• Tequin (gatifloxacin)
• Maxaquin (moxifloxacin)
• Noroxin (norfloxacin)
• Floxin (Ofloxacin)

If you, a friend or family member suffered an Achilles tendon rupture or other tendon damage after taking Levaquin or one of the other fluoroquinolone antibiotics, request a free consultation and claim evaluation.

>>PRIOR POST (1/7/08): Cipro and Levaquin lawsuit filed by consumer group
regarding risk of tendon ruptures

Fluoroquinolones are a class of antibiotics which are used to prevent bacteria from reproducing in the body, which could cause infection. Levaquin (levofloxacin) and Cipro (ciprofloxacin) are two of the more popular drugs in this class of antibiotics, but others which could also be associated with the risk of tendon damage include Tequin (gatifloxacin), Penetrex (enoxacin), Factive (gemifloxacin), Maxaquin (lomefloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), Floxin (Ofloxacin) and Trovan (trovafloxacin).

For over a decade, manufacturers of these antibiotics have received reports of people suffering inflamed or ruptured tendons, particularly in the shoulder, hand and Achilles tendon. The tendon problems have occured within a few days of taking the antibiotic or months after the course of therapy is finished.

Tendon ruptures are a serious and debilitating injury which can require extensive therapy, weeks of casting and possible surgery. An achilles tendon rupture is a complete tear of the tendon which connects the calf muscle and the heel of the foot. A tear of this tendon could cause the heel to lose stability, impairing a person’s ability to walk, run, jump or perform any activities which involve use of the foot.

Last month the consumer advocacy group, Public Citizen, filed a Cipro and Levaquin lawsuit against the FDA asking the court to require the drug regulators to act on a petition they filed over a year ago.  Although the current warning label does mention the risk of tendon damage, Public Citizen believes that stronger warnings should be added to the label and that a seperate information guide should be provided to those taking the drug so that they will know that the first signs of tendon problems should be reported to their doctors.

Education about the possible risks of Cipro and Levaquin tendon ruptures could help prevent inflamed tendons from actually rupturing. The adverse effects of the antibiotics could be compounded with prolonged exposure to the drugs, and if early symptoms of tendon problems are reported, a doctor may switch their patient to a different type of antibiotic.

CIPRO AND LEVAQUIN TENDON RUPTURE LAWSUITS

The lawyers at Saiontz & Kirk, P.A. are reviewing the potential for Cipro and Levaquin lawsuits on behalf of users of fluoroquinolone antibiotics who have suffered a ruptured tendon or permanent tendon damage. If you, a friend or family member have experienced tendon problems after using an antibiotic, request a free consultation.

Public Citizen is an independent national consumer advocacy organization. They originally filed a petition with the FDA on August 29, 2006 requesting that stronger warnings be issued about Cipro and Levaquin tendon rupture side effects. Last week they filed a federal lawsuit asking the court to require the FDA to act on their petition, in accordance with the Administrative Procedure Act.

The tendon problems could be associated with all antibiotics which are part of the fluoroquinolone family, including:

• Cipro (ciprofloxacin)
• Levaquin (levofloxacin)
• Tequin (gatifloxacin)
• Penetrex (enoxacin)
• Factive (gemifloxacin)
• Maxaquin (lomefloxacin)
• Avelox (moxifloxacin)
• Noroxin (norfloxacin)
• Floxin (Ofloxacin)
• Trovan (trovafloxacin)

The FDA has received reports of at least 336 individuals who experienced a tendon rupture after using Cipro, Levaquin or one of the fluoroquinolone antibiotics. The most common tendon rupture involved the Achilles tendon. In addition, hundreds of other people have experienced tendonitis and other tendon disorders. The numbers are concerning, since drug side effects actually reported to the FDA typically only involve about 1% to 10% of all problems experienced by users.

Public Citizen’s complaint indicates that the FDA has failed to require that the antibiotic manufacturers provide stronger warnings to protect users from the risk of tendon damage. The group argues that if consumers and doctors are made more aware about the potential risk of tendon ruptures, it could lead to earlier intervention and help avoid injuries, as many patients could be switched to another antibiotic if symptoms of a tendon rupture are recognized early.

The current warning labels for Levaquin and Cipro do include indication about potential risk of ruptured tendons, but the information is at the bottom of a list of other side effects on the antibiotics. Public Citizen indicates that the risk of tendon damage should be contained in a “black box warning”, which is the strongest warning that can be placed on a prescription medication. In addition, they argue that those given the antibiotics should receive pamphlets specifically explaining how they should immediately stop using the drugs if they experience pain or inflammation, which could be symptoms before a tendon ruptures.

If you, a friend or family member have suffered tendonitis or a tendon rupture which may be caused by side effects of Levaquin, Cipro or another antibiotic, contact the lawyers at Saiontz & Kirk, P.A. to review your legal rights. Request a free legal consultation.

>>FDA LINK: Maxipime Risk of Death

Maxipime for Injection is the brand name for cafeprime hydrochloride.  Bristol-Myers Squibb Company manufactures the antibiotic and it is licensed for exclusive marketing in the United States to Elan Biopharmaceuticals.  It is a broad spectrum B-lactam antibiotic which has been approved for treatment of a variety of serious infections, such as:

• Pneumonia
• Empiric therapy for febrile neutropenic patients
• Uncomplicated and complicated UTIs, including pyelonephritis
• Uncomplicated skin and skin structure infections
• Complicated intra-abdominal infections.

Concerns about the Maxipime death risk surfaced after a report was published in the May 2007 issue of the Lancet Infections Diseases.  A meta-analysis reviewed several studies which suggested that the Maxipime death rate was higher than that associated with patients who took other drugs in the same class of medications.

The early communication issued by the federal drug regulators is not an indication that the FDA has reached a conclusion about whether the information warrants additional warnings or other actions by the agency.  They indicate that it will likely take about four months for the FDA to complete their evaluation of the Maxipime side effects, at which time any resulting recommendations will be released to the public.

At this time, the FDA has cautioned healthcare providers to be aware of the Maxipime risks and benefits.  Any side effects of Maxipime should be reported to the FDA’s MedWatch Adverse Event Reporting program at http://www.fda.gov/medwatch/report.htm.  If a friend or family member has died after receiving the injectable antibiotic Maxipime (cafeprime), contact our office to review the potential legal rights which may exist.  Request a free consultation.

>>FDA LINK: Antibiotic Rocephin Injection Warning

Rocephin (generic ceftriaxone sodium) has been linked to an unspecified number of deaths for recently born babies.  The new warning will indicate that the antibiotic injection should not be given to hyperbilirubinemic newborns, especially premature babies.  Also, the drug should not be mixed or administered within 48 hours of any solutions or products which contain calcium, even if they are given through different infusion lines. 

Deaths have been reported as a result of reactions with calcium and Recephin which occurs in the lungs or kidneys.  It has been seen in both full term babies and premature newborns.

If your child or loved one suffered a fatal reaction as a newborn after receiving the antibiotic Rocephin injection, request a free legal consultation.

The FDA committee met last week to review the risks associated with the antibiotic and considered whether a Ketek recall was necessary to protect the public.  Although it was determined that the risk of Ketek liver damage outweighs the benefits provided by the drug for treatment of sinusitis and bronchitis, the committee found that it should still be approved for treatment of pneumonia, a more serious condition.  Therefore, the committee has not recommended that the antibiotic be removed from the market.

>>MORE INFORMATION: Ketek liver damage side effects

The manufacturer of Ketek will likely be required to do more to warn the public of the risks of liver damage associated with the antibiotic.  Most members of the FDA committee felt that Ketek dangers were serious enough to require a “black box” warning.  This would be the most serious warning which the FDA could require.

Ketek lawsuits are being pursued against Sanofi-Aventis for failing to warn users of the liver dangers.  Although they were aware of the serious Keteck side effects, they failed to provide sufficient warning to users which would allow them to determine whether the risks are acceptable for treatment of their illness.  Many believe that the pharmaceutical company has resisted placing a full warning on their antibiotic out of fear that it would reduce their sales, which exceeded 3.3 million prescriptions in the United States last year.

The proposed restrictions on Ketek follow months of controversy surrounding approval of the antibiotic.  Many have called for a Ketek recall after fraud and other problems were discovered in the studies used by the manufacturer to gain FDA approval.  Keteck side effects increase the risk of liver damage, which could lead to death for some users.  Symptoms of Ketek liver damage could include fatigue, malaise, anorexia, jaundice and nausea.  If any of these symptoms are noted after use of the antibiotic, a liver function test should be obtained.

>>PRIOR NEWS 11/14/2006: Ketek recall to be reviewed by FDA

If you, a friend or family member have suffered Ketek liver damage, you may be eligible to pursue a lawsuit claim.  To determine if you are entitled to compensation for your injuries, request a free claim evaluation.

The FDA scientist, Dr. David Graham, wrote that the agency’s decision to approve Ketek in 2004 was made without reliable data disproving the earlier safety concerns expressed by a 2001 advisory committee which recommended against approval.  Overseas data was used to gain approval instead of requiring the company to obtain new studies.  Since the antibiotic has been on the market, there has been an alarming rate of liver failure and death among users.  This has led to serious concerns in the medical and legal community about the FDA approval process and whether further steps should have been taken to protect consumers.

Rates of Ketek liver failure were cited as being 3.5 to 11 times higher than with other antibiotics used to treat the similar conditions.  Dr. Graham wrote:

“Given that (Ketek) is neither clinically superior to other drugs prescribed for respiratory tract infections nor uniquely life saving, physicians, patients and third party payors might wish to reconsider their choice of antibiotics for such infections.”

>>RELATED POST (11/14/06): FDA to consider Ketek Recall 

The product liability lawyers at Saiontz & Kirk will be closely monitoring the upcoming FDA hearings where they may consider a possible Ketek recall.  For the last six months, we have been reviewing potential Ketek lawsuits for users who have suffered liver damage, liver failure or death.  If you, a friend or family member believe you may have a case, request a free claim evaluation.