Breaking News:  The Food and Drug Administration announced Wednesday that Avandia will be pulled from pharmacy shelves as a result of the diabetes drug’s cardiovascular threat to patients.  A 2007 analysis conducted by the Cleveland Clinic cardiologist Steven Nissen, M.D., found that those with type 2 diabetes who took Avandia (rosiglitazone) had a 40% increase in heart attack risk. Beginning on Nov. 18, only certified doctors will be able to prescribe the drug, and only to patients who have been alerted to the risks, who have already taken the drug safely, and who have found that other medications did not control their diabetes. 

We are in settlement negotations with GlaxoSmithKline (”GSK”), the manufacturer of Avandia.  Submit your Avandia case for a Free Case Evaluation or call 314-662-2836, and one of our experienced attorneys will evaluate your case.  This is not a class action;  your case will be individually litigated.    

Our national law firm represents individuals injured by America’s largest corporations.   Our lawyers have recovered over $810 million for our clients, including individual settlements of over $10 million and class-wide settlements of over $90 million. It is our clients who are our most important asset.

Latest Avandia News:

A federal medical advisory panel recommended Wednesday that Avandia, a controversial diabetes drug, should either be withdrawn from the market or have sales severely restricted because it increases the risks of heart attacks.

The panel members also voiced great skepticism about the company’s trustworthiness after questions were raised about its clinical trials. And internal company documents showed that the company for years kept crucial safety information about Avandia from the public.

Read full article at New York Times:  “F.D.A. Panel Votes to Restrict Avandia”

New York Times:  “Avandia Panel Hints at Doubts Over Credibility”

New York Times:  “Diabetes Drug Maker Hid Test Data, Files Indicate”

GlaxoSmithKline misleads FDA about the dangers of Avandia in its Record study

Avandia, manufactured by GlaxoSmithKline (GSK), has been coming under criticism for dangerous cardiovascular adverse effects, including heart attacks and sudden cardiac death.  Because of the criticism, the FDA has scheduled a safety review for 13-14 July.  The FDA reapproved this drug in 2007 partly on the evidence of GSK’s RECORD study of Avandia.

Thomas Marciniak, an FDA medical team leader, analyzed one of the recent GSK-sponsored trials and discovered that the company had made mistakes in its data analysis and that increased heart risks were indeed present in Avandia users. In some cases, the researchers who conducted the so-called “Record” study, one of the trials cited by GSK, failed to count heart attacks and hospitalizations as heart-related conditions and failed to investigate some deaths in Avandia users to see whether they may have been caused by the drug.  In a memo posted today on the FDA website, Marciniak called the study “inadequately designed” and alleged it was conducted to reassure the public of the drug’s safety even though the data suggested otherwise. Another analysis comparing Avandia with Actos, the only other diabetes drug in the same class, found that the likelihood of major heart events like heart attacks or strokes “tended to be less” with Actos and “tended to be greater” with Avandia, according to FDA statistician Bradley McEvoy.

“One does not have to be a mathematician or to perform calculations,” he wrote, to come to the conclusion that a combined look at all the trials of Avandia would demonstrate it causes heart attacks.

GlaxoSmithKline withheld study showing Avandia’s associations with heart attacks

A former U.S. Food and Drug Administration official said GlaxoSmithKline withheld from regulators a study showing its Avandia diabetes drug may cause heart attacks, according to two people familiar with her deposition in a lawsuit against the drugmaker.

Dr. Rosemary Johann-Liang, a former manager in the FDA’s drug-safety unit, told lawyers suing Glaxo that the 2001 study found Avandia posed a greater heart-attack risk than rival medicines.  Glaxo also didn’t turn over an e-mail from researchers who concluded Avandia “strengthens the signals” of heart ailments, she testified in a pre-trial deposition last month, according to the people.

Johann-Liang left the FDA in 2007 following her recommendation that London-based Glaxo add more information about health risks to Avandia’s label. Johann-Liang stated that FDA officials provided the drugmaker with details of internal agency discussions about beefing up the warnings, and that these leaks “should not have happened” and violated FDA policy.

Johann-Liang’s deposition may be considered by an FDA advisory panel meeting next week in Washington to consider whether Avandia’s ability to control blood-sugar levels outweighs a possible increase in heart attacks, strokes and deaths from cardiovascular disease.

Two new studies show strong evidence that the diabetes drug Avandia increases the risk for heart attacks and strokes

The first study involved more than 35,500 patients and found that Avandia significantly raises the chances of a heart attack.  Steven E. Nissen, a Cleveland Clinic cardiologist, conducted the analysis of the data.  The data was pooled from 56 studies involving 35,531 patients, including 19,509 who took Avandia.  In a paper released online by the Archives of Internal Medicine, the researchers of this study concluded the drug increased the risk for heart attacks from 28 percent to 39 percent. The pair calculated that the drug would cause one heart attack among every 37 to 52 patients who used it for five years.

The results of the second study were released online by the Journal of the American Medical Association.  David J. Graham of the FDA’s Center for Drug Evaluation and Research conducted the second new analysis.  Graham and his researchers found those who took Avandia were 27 percent more likely to suffer a stroke, 25 percent more likely to develop heart failure and 14 percent more likely to die compared with those who took Actos. Based on the findings, the researchers estimate that there would be one heart attack, death, stroke or heart failure in every 60 patients who took the drug for one year.

Senate Report states that Avandia estimated to have caused between 83,000 heart attacks between 1999 and 2007

Sen. Max Baucus, chairman of the Senate Finance Committee, and Chuck Grassley, the committee’s ranking Republican, released the report, which follows a two-year inquiry, on Saturday. They are asking the U.S. Food and Drug Administration why it permitted a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007.  The agency ordered a warning to be included on Avandia’s label in 2007, stating that it might increase the risk of heart attacks, though the data on those risk was inconclusive.

In a letter to FDA Commissioner Margaret Hamburg, the senators said the committee’s report was based on researchers’ studies of Avandia, internal GlaxoSmithKline documents and FDA documents. They said committee investigators had interviewed GlaxoSmithKline and agency employees as well as what it called anonymous whistleblowers.The senate report concluded that based on its knowledge of the heart attack risks, GlaxoSmithKline ”had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner.”  Instead, the report stated that the company tried to downplay findings that the drug could increase cardiovascular risks while also working to downplay findings that a rival medication might reduce such risks.

In their letter to the FDA, the senators said the documents the committee reviewed included an analysis conducted by two safety officials at the agency. The analysis compared Avandia to Takeda Pharmaceutical’s diabetes drug Actos, and found that Avandia has an increased risk of heart attack and heart failure. Actos is co-promoted by Pfizer Inc.

Avandia has now been shown to cause heart attacks, sudden cardiac death, strokes, and congestive heart failure in patients taking the drug.

If you have taken Avandia to help treat diabetes and have symptoms of, or have been diagnosed with congestive heart failure or a heart attack, call us today. There is a good chance you have been injured by Avandia and that you are owed financial compensation.

Avandia is prescribed by a doctor to patients with diabetes. Avandia was designed to help control the blood sugar levels in diabetics by helping the body make use of naturally occurring insulin better. Avandia is a brand name for rosiglitazone.Avandia is sometimes combined with other diabetic medications into a single pill. When your doctor prescribes one of these two combinations, the medication will have a different label but still contain Avandia:

* Avandamet – Contains Avandia and metformin.
* Avandaryl – Contains Avandia and glimepiride.

The Most Serious Side Effect

Avandia has been associated with “PPH,” which stands for Primary Pulmonary Hypertension. This condition has no cure, but can be somewhat managed if it’s diagnosed in its early stages. Symptoms that have drawn the most concern from doctors and Avandia attorneys include:

* Chest pains
* Heart murmur
* Fatigue
* Shortness of breath

These conditions can all be debilitating, and they can all lead to the death of a patient. These reports ultimately led to the FDA posting a report of the drug on its Web site in January of 2006.

Paxil Birth Defect Attorneys

Submit your Paxil case for a Free Case Evaluation or call 314-662-2836, and
one of our experienced attorneys from a national law firm will evaluate your case.  We are presently investigating and filing our Paxil birth defect cases.

What is Paxil?

Paxil®

Paxil (paroxetine) is one of a class of medicines called Selective Serotonin Reuptake Inhibitors (SSRIs). Paxil was first approved in the United States on December 29, 1992, for the treatment of depression. Paroxetine is available as Paxil, Paxil CR, Pexeva, and generic paroxetine hydrochloride. It is manufactured by GlaxoSmithKline.

What Injuries Can Paxil/Other SSRI’s Cause?

Since September, 2005 information has been coming out that Paxil may cause birth defects, including cardiac (heart), pulmonary (lung), neural-tube defects (brain and spinal cord), craniosynostosis (abnormally shaped skull), infant omphalocele (abdominal wall defects), club foot (one or both feet turn downward and inward), and anal atresia (complete or partial closure of the anus). The FDA issued an alert in July 2006 warning about the increased risk of Neonatal Persistent Pulmonary Hypertension (PPHN) by mothers taking SSRI antidepressants such as Celexa (citalopram), Fluvoxamine, Lexapro (escitalopram), Paxil (paroxetine), Prozac (fluoxetine, Symbyax (olanzapine and fluoxetine) and Zoloft (sertraline).

What is Neonatal Persistent Pulmonary Hypertension (PPHN)?

In the womb, the pathway of your baby’s blood circulation is different than it is after birth. In the uterus, a baby’s circulation bypasses the lungs, and instead the placenta, through the umbilical cord, serves as the organ of gas exchange. The pulmonary artery – which, after birth, will carry blood from the heart to the lungs – in utero sends blood directly back to the fetal heart through a fetal blood vessel called the ductus arteriosus.

When a baby is born and begins to breathe air on their own, the baby’s circulatory system is shifting from the placenta to the lungs serving as the organ of gas exchange. The pressure in the lungs changes as air enters and inflates the lungs. Because of this, the ductus arteriosus, which previously supplied the fetal heart with blood, closes for good. Blood returning to the heart from the body can now be pumped into the lungs, where oxygen and carbon dioxide are exchanged. The blood is then returned to the heart and pumped back out to the body in an oxygen-rich state.

A dramatic cardiopulmonary transition occurs at birth, characterized by a rapid fall in pulmonary vascular resistance (PVR) and pulmonary artery pressure and a 10-fold rise in pulmonary blood flow. In some newborns, however, the normal decrease in pulmonary vascular tone does not occur, and the result is persistent pulmonary hypertension of the newborn (PPHN).

In a baby with PPHN, the fetal circulatory system doesn’t “switch over.” The ductus arteriosus remains open, and the baby’s blood flow continues to bypass the lungs. Even though the baby is breathing, oxygen in the breathed air will not reach the bloodstream. Because the blood returning from the body is unable to enter the lungs properly – and instead flows through the still-open ductus arteriosus – it returns to the heart in an oxygen-depleted state.

What are atrial and ventricular septal defects (VSDs) of the heart?

A ventricular septal defect (VSDs) is a defect in the ventricular septum, the wall dividing the left and right ventricles of the heart. In other words, VSDs are holes in the walls of the chambers of the heart. A VSD can be detected by cardiac auscultation. Normally, a VSD causes a pathognomonic holo- or pansystolic murmur. VSDs can be diagnosed by non-invasive cardiac echocardiograms.

Atrioventricular septal defect (AVSD) or atrioventricular canal defect (AVCD) is characterized by a deficiency of the atrioventricular septum of the heart.If there is a defect in the septum, it is possible for blood to travel from the left side of the heart to the right side of the heart, or the other way around. Since the right side of the heart contains venous blood with a low oxygen content, and the left side of the heart contains arterial blood with a high oxygen content, it is beneficial to prevent any communication between the two sides of the heart and prevent the blood from the two sides of the heart from mixing with each other.AVSDs can be detected by cardiac auscultation as they cause atypical murmurs and loud heart beats. VSDs also can be diagnosed by non-invasive cardiac echocardiograms.

What are the abdominal birth defects associated with Paxil and other SSRIs?

GlaxoSmithKline (“GSK”), maker of Paxil, sent a letter to doctors and healthcare professionals in September, 2005 advising them of a Paxil label change that, according to data obtained from the National Birth Defects Prevention Study of infants, women who took an SSRI-antidepressant were more likely than those who were not exposed to have an infant with omphalocele, which is an abnormality in newborns in which the infant’s intestine or other abdominal organs protrude from the navel. The strongest effect was reported to be with Paxil, paroxetine, which accounted for 36% of all SSRI exposures.

An omphalocele is a type of abdominal wall defect in which the intestines, liver, and occasionally other organs remain outside of the abdomen in a sac because of a defect in the development of the muscles of the abdominal wall. The omphalocele can be mild, with only a small loop of intestines present outside the abdomen, or severe, containing most of the abdominal organs. In severe cases surgical treatment is made more difficult because the infant’s abdomen is abnormally small because it had no need to expand to accommodate the developing organs. The presence of an omphalocele is often associated with cardiac defects.

What is Craniosynostosis?

Craniosynostosis is a condition in which one or more of the fibrous sutures in an infant skull prematurely fuses. This results in restricted skull and brain growth. Because the brain cannot expand in the direction of the fused suture, it is forced to grow in the direction of the open sutures, often resulting in an abnormal head shape and facial features.

In an infant, the skull is not one solid bone, it is bony plates separated by fibrous sutures. The infant’s skull consists of the metopic suture, coronal sutures, sagittal suture, and lambdoid sutures. These sutures allow the skull to expand as an infant’s brain develops. Over time these sutures eventually fuse into the solid skull.

Surgery is typically used to separate the fused sutures of the skull as well as to reshape the skull. To treat the cosmetic troubles, a combination of orthodontic and orthognathic surgery can be used to relieve some of the midface deficiency.

GSK – GlaxoSmithKline included in the September, 2005 “Dear Doctor” letter that the authors of the above study also found an association of exposure to any SSRI-antidepressant and giving birth to an infant with craniosynostosis (a congenital defect-present at birth. The connections between sutures-skull bones, prematurely close during the first year of life, which causes an abnormally shaped skull.)

Other Birth DefectsOur firm is also investigating the possible link between Paxil and birth defects such as:

Club Foot: A recent study conducted by the Institute of Reproductive Toxicology at the University of Ulm, Germany and a recent study from the Slone Epidemiology Center at Boston University found that some women who took SSRIs throughout their pregnancy had children born with club feet. True Club foot is a malformation. The bones, joints, muscles, and blood vessels of the limb are abnormal. An infant with club foot has a foot that is inturned, stiff and cannot be brought to a normal position.

Neural Tube Defects: Neural tube defects (or NTDs) are birth defects of the brain and spinal cord. The two most common neural tube defects are spina bifida and anencephaly. In spina bifida, the fetal spinal column doesn’t close completely during the first month of pregnancy. There is usually nerve damage that causes at least some paralysis of the legs. In anencephaly, much of the brain does not develop. Babies with anencephaly are either stillborn or die shortly after birth. Source: National Institute of Child Health and Human Development.

Anal Atresia: Also called Imperforate anus, anal atresia is a congenital malformation in which the normal perforation we call the anus, is absent. The end of the intestinal tract has not perforated the skin in the perineal area. Atresia is the absence of a normal opening or failure of a structure to be tubular.

Contact our Paxil birth defect attorneys at 314-662-2836.

Mirapex has been associated with compulsive behavior, including gambling addiction

Submit your Mirapex case for a Free Case Evaluation or call 314-662-2836, and one of our experienced attorneys from a national law firm will evaluate your case.

Mirapex – also known as pramipexole -, which is used to treat Parkinson’s Disease and restless leg syndrome, has been associated with compulsive behavior, including gambling addiction.  If you or someone you know developed a gambling addiction or some other compulsive behavior after starting treatment with this drug, contact one of our Mirapex side effect attorneys.

Mirapex Breaking News

Mirapex Victim Awarded $8.2 Million in First Gambling Addiction Lawsuit

The first Mirapex lawsuit to go to trail has resulted in an $8.2 million
award to the plaintiff, Mealey’s Emerging Drugs & Devices is reporting. The lawsuit was the first of more than 300 to go to trail in the Mirapex multidistrict litigation in the US District Court in Minneapolis that blame the Parkinson’s Disease drug for causing compulsive gambling. It was considered a bellweather case, and was being watched by many to gauge the strengths and weaknesses of the other Mirapex lawsuits.

Gary Charbonneau, who began taking Mirapex in December 1997, said he suffered from a gambling addiction from March 2002 to February 2006. In that period of time, he gambled away $260,000.  Charbonneau’s lawsuit not only claimed that Mirapex caused his gambling problem, but that the drug’s makers, Pfizer and Boehringer Ingelheim, knew about its potential to cause compulsive behavior, but did not issue any warnings, or take steps to investigate the true scope of the problem.

Mirapex Information

Mirapex is a dopamine agonist. This means it stimulates nerves in the brain which are normally stimulated by dopamine, a brain chemical that helps control motor functions and movement. Mirapex is the most commonly prescribed drug in its class.

Mirapex was approved by the FDA in 1997 and by the end of 2004 accounted for almost 18 percent of prescriptions written to treat Parkinson’s disease.  Since its approval, hundreds of Mirapex users have claimed that they developed compulsive behaviors.

In addition to gambling addictions, people treated with Mirapex have suffered from compulsive shopping, sexual addictions, eating disorders, and other impulse control disorders.  In almost case, the victims of Mirapex side effects had no prior history of obsessive compulsive behaviors.  And in most cases, the compulsive behavior subsides once Mirapex is discontinued.

Mirapex has long been suspected of causing compulsive behavior.  The suspicion was bolstered in June, when researchers investigating the link between dopamine agonists and compulsive behavior presented their findings at  International Congress of Parkinson’s Disease and Movement Disorders conference in Chicago.  The study, which looked at more than 3,000 patients from 46 medical centers in the United States and Canada, found that Parkinson’s patients on dopamine agonists are nearly three times more likely to have at least one impulse-control disorder – including gambling addiction – compared with patients receiving other treatments.

Mirapex Label Change

Due to these reports, the Mirapex package insert was changed to state adverse events including “accidents (including fall), compulsive behaviors (sexual and pathological gambling), fatigue, hallucinations (all kinds), headache, hypotension, libido disorder, syncope, and blackouts.”Furthermore, a 2003 report in the journal “Neurology” covered the work of researchers at the Muhammad Ali Parkinson Research Center in Arizona. They surveyed 1,800 Parkinson’s patients over a one year period and determined that of the 529 patients in the study who took Mirapex, eight developed gambling addictions.  Since Mirapex is prescribed to millions of patients, this means that thousands of users may be experiencing these compulsions.