One of the major side effects of Crestor (Rosuvastatin) is a potentially life threatening disorder known as Rhabdomyolysis.  Rhabdomyolysis is a muscle disease that depletes muscle-mass and strength in the human body.  Sometimes this muscle depletion occurs only in specific and limited areas of the body, while in some instances, the muscle-mass loss occurs over the entire body.  Regardless of which manifestation of Rhabdomyolysis occurs, the heart is clearly at risk.  In simple terms, Rhabdomyolysis can cause weakness and damage in the most important muscle in the body, the heart.

In a research study conducted by the independent watchdog group, Public Citizen, prescription data for Crestor was compared to that of other statin drugs. This research study showed that Crestor caused rhabdomyolysis almost 22 times more than its lowest dose competitor and 3 times more than its highest dose competitor. These are highly significant results.

The reason for the study’s outcome is that the higher the dose of the active ingredient, Rosuvastatin, the higher the risk of rhabdomyolysis. AstraZeneca, the Swiss drug giant, promotes Crestor as being the most powerful statin on the market.  This may be true, but at what cost to a patient’s health? Especially since Crestor’s advertised “strength” comes from a significantly higher dosage of Rosuvastatin, its active ingredient. Recent studies have shown that only 10 mg of Crestor (Rosuvastatin) has a significantly positive effect, but these positive benefits plateau and the negative side effects of rhabdomyolysis, heart failure, heart attack, stroke liver failure, kidney failure, and potentially diabetes increase significantly at the higher prescribed and advertised dosages.

At the higher prescribed dosages, Crestor may indeed have slightly better results, but the risks for heart damage, stroke, kidney damage, liver damage and even diabetes begin to far outweigh any possible extra benefits gained.

Crestor: Heart Attacks, Heart Failure and Strokes?

As with all statins a cholesterol patient will notice weakness and fatigue. If this turns into rhabdomyolysis, then the benefits of lower risk of heart attack through lower cholesterol and potentially unclogged arteries is soon undone. The potential problems of higher cholesterol are then replaced with a very real and long lasting disease that may be worse than the original cholesterol problem.  Rhabdomyolysis has the potential to cause a series of serious problems including heart attack, stroke, kidney failure, liver failure, and possibly even diabetes.

John Kjekshus of the University of Oslo and his colleagues conducted a study of 5000 cholesterol sufferers which showed that the benefits of Crestor were not as significant as advertised, when compared to a placebo (non-working dummy medication) in the study, but the weakening of the heart from rhabdomyolysis became a very major concern, especially in patients who were already at risk for possible heart failure.

“Our findings suggest the major cause of death in these patients was likely not to be related to atherosclerotic events, where benefit with statins in non-heart failure patients has been demonstrated, but instead may have been caused by the deterioration of failing heart muscle damaged beyond repair,” John Kjekshus of the University of Oslo said.

There is a difference between a heart attack and heart failure. Heart failure is a hard-to-treat condition in which the weakened heart cannot pump enough blood to meet the body’s need for oxygen, causing shortness of breath or other complications. Heart failure is a leading cause of hospitalization among the elderly.

But at a certain point the depletion of the heart muscle from rhabdomyolysis leads not only to heart attacks, but also to strokes. Strokes are due to the lack of blood pressure flowing through the brain from the heart potentially weakened by rhabdomyolysis. Strokes can lead to paralysis, loss of speech, severely degraded cognitive ability or death.

The Swiss drug giant AstraZeneca produced and heavily marketed Crestor to profit from the increased awareness of high-cholesterol and its potential serious affects on the health of some as they age. Crestor, having a significantly higher dose of rosuvastatin as compared to other statins, makes it unique.  This significantly higher dosage may actually be the wrong approach to the root cause of the problem of high cholesterol. In actuality, this formulation may make the side effects much, much worse, with few if any additional benefits to warrant the increased risk.

The increased dosage of Crestor has been found in a study conducted by Public Citizen to cause Crestor patients to also have renal (kidney) failure 75 times more than other statins. That is a much higher risk of kidney failure with Crestor than with other statins. This is an especially major risk and complication for cholesterol patients who may have already had kidney problems or may be suffering from liver damage at the time they are prescribed Crestor.

These study results prompted a request to the FDA in 2004 that they take Crestor off of the market. The FDA responded to that request with the results of AstraZeneca-sponsored research projects, and a firm refusal. The FDA has currently yet to revise or strengthen the side effects and warnings on the drug package label or order any other independent studies of their own to address these claims or to resolve the issue through research and objective science.

AstraZeneca’s sales of Crestor have been rising steadily with sales of more than $2.5 billion per year in 56 markets around the world. In other words, millions upon millions of cholesterol patients worldwide, some already with diminished heart, kidney and liver functionality, are being put at risk of the serious and possibly life threatening Crestor side effects.  According the referenced studies, Crestor’s side effects include heart failure, heart attack, stroke, kidney failure, liver failure, and diabetes, among other health risks.

Speak to a Crestor Lawyer about a Crestor Heart Failure Lawsuit

If you or a loved one took the cholesterol drug Crestor (Rosuvastatin) and experienced heart failure, stroke, kidney failure or liver failure please contact a Crestor Lawsuit Attorney at our law firm immediately. It may be too late to recover from some the devastating effects of Crestor, but an experienced pharmaceutical products liability lawyer at the Willis Law Firm can assist you in legal action against AstraZeneca, the maker of this dangerous drug. You are not alone. Join other Crestor victims and their families in speaking up and fighting for your legal rights.

Please fill out our free online legal evaluation form and we will contact you within 24 hours, or call our offices at 1-800-883-9858 for immediate help. Please keep in mind that certain states have statutes of limitation that limit the amount of time you have to file a lawsuit or seek legal action. Contact our law firm immediately so that we may explain the rights and options available to you and your family.

What is Zoloft?

Zoloft (Generic: sertraline) is grouped with other antidepressants as a Selective Serotonin Re-uptake Inhibitor (SSRI) which works by raising serotonin levels in the brain, regulating mood, sleep and appetite. Zoloft (sertraline) affects chemical levels in the brain which may become unbalanced and create symptoms. Zoloft (sertraline) is used to treat depression, bulimia nervosa, obsessive-compulsive disorder (OCD), panic disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD). Researchers from the University of Pittsburgh estimated in May 2005 in the Journal of the American Medical Association, that in any given year at over 80,000 pregnant women in the U.S. are prescribed SSRIs.

What is Hypoplastic Left Heart Syndrome (HLHS)?

Causes

If part of the endocardial tube gets pinched shut in a region that becomes the future ventricle, hypoplastic heart syndrome will occur. If the pinched part of the endocardial tube is the bulbus-cordis region of the developing heart, hypoplastic RIGHT syndrome will occur. If it is in the ventricle region it will be the LEFT side that is hypoplastic.

There is evidence associating it with Gap junction protein, alpha 1.

Colleagues at Cincinnati Children’s Hospital in Ohio studied 1,500 newborns from 38 children’s hospitals in the United States from the 1990s to 2006. They found that babies born between April and July were more likely to have this defect. Establishing strong evidence that seasonality and environmental factors play a significant role in causation. PMID: 20817208

Presentation

In babies with HLHS, the aorta and left ventricle are very small, and the aortic and mitral valves are either too small to allow sufficient blood flow or are atretic (closed) altogether. As blood returns from the lungs to the left atrium, it must pass through an atrial septal defect to the right side of the heart.

In a healthy human, the left side of the heart receives oxygen-rich blood from the lungs and pumps it out to the rest of the body; with these structures underdeveloped, they cannot circulate blood to other organs, and the right ventricle must pump blood to both the lungs, as it would normally, and to the rest of the body, a situation which cannot be sustained for long.

In cases of HLHS, the right side of the heart often must pump blood to the body through a patent ductus arteriosus. As the ductus arteriosus usually closes within eleven days after birth, blood flow is severely restricted and eventually cutoff, leading to dangerously low circulation and eventually to shock.

Treatment

Without life-prolonging interventions, HLHS is fatal, but with intervention, an infant may survive. A pediatric cardiothoracic surgeon may perform a series of operations or a full heart transplant. In the meantime, the ductus may be kept open to allow blood-flow using medication containing prostaglandin. Because these operations are complex and need to be individualized for each patient, a cardiologist must assess all medical and surgical options on a case-by-case basis.

Currently, infants who undergo either the staged reconstructive surgery (Norwood procedure in infancy, Glenn procedure at 3 to 6 months of age, and the Fontan procedure at 3 to 5 years of age) or who undergo cardiac transplantation have a 5-year survival of approximately 60%. Further, studies show that about 50% of those children who survive surgery have developmental delay or need special education. About 25% of surgical survivors have severe disabilities. An alternative to the traditional Norwood is the Hybrid procedure, developed by Mark Galantowicz MD at Nationwide Children’s Hospital.

The traditional three-stage procedure is a palliative procedure (not a cure), as the child’s circulation is made to work with only two of the heart’s four chambers.

• The first step is the Norwood procedure. In this procedure, the right ventricle is used to pump blood into the systemic circulation. Since the right ventricle is no longer directly pumping blood to the lungs, a shunt is required in order to pass deoxygenated blood through the lungs. Either the subclavian artery can be connected to the pulmonary circulation (Blalock-Taussig shunt), or a shunt is made directly from the right ventricle to the pulmonary circulation (Sano shunt). The narrow aorta is enlarged using a patch to improve blood-flow to the body.

During this time the baby may be medically fragile and have feeding problems because the heart is working very hard. There is a considerable degree of venous mixing in the right ventricle, leading to lower oxygenation saturations. In addition, the Blalock-Taussig shunt and the Sano shunt both expose the lungs to systemic arterial pressures, leading in the long term to pulmonary hypertension and eventually to heart failure.

• The Hybrid procedure is used in place of the Norwood. The Hybrid procedure does not necessitate the use of heart-lung bypass or cracking the chest. Instead of a six-hour surgery, the Hybrid typically takes one-two hours. In the procedure, a stent is placed in the Ductus Arteriosis to maintain its patency, and the Pulmonary Artery has a band placed over it to limit over-circulation to the lungs. Outcomes with the Hybrid approach are comparable with the Norwood.

• The second stage, the bi-directional Glenn procedure or Hemi-Fontan relieves some of the above problems. In this operation, the superior vena cava is ligated from the heart and connected to the pulmonary circulation. At this time, the Blalock-Taussig or Sano shunt is taken down. At this point, the lungs are no longer exposed to systemic arterial pressures, but much lower venous pressures. Although venous blood from the upper half of the body is no longer mixing with oxygenated blood in the right ventricle, there is still venous mixing from the lower half of the body, leading to some degree of oxygen desaturation.

During this time the child may have improved quality of life as the heart does not have to work as hard.

• The final procedure, the Fontan (Fontan procedure) completes the repair of the hypoplastic left heart. Although there are several variations, the functional effect is to redirect venous blood from the lower body (through the inferior vena cava) away from the right atrium to the pulmonary artery. Now, there should not be any mixing of oxygenated and deoxygenated blood in the right ventricle. The right ventricle performs the traditional job of the left, supplying the body with oxygenated blood, while the passive systemic venous pressure performs the traditional job of the right, passing deoxygenated blood to the lungs.

The Norwood Procedure is generally performed within a week of birth, the second stage at 3–6 months of age, and the Fontan at 18 months to four years of age. There are two types of Fontan: the Lateral Tunnel Fontan, and the Extracardiac Fontan. When the Fontan Procedure was first being done for children with HLHS, the only Fontan was the Lateral Tunnel Fontan. This requires actual cutting in the heart itself to create a “tunnel” by which the blood can travel passively to the lungs. Within the last decade, doctors have created an Extracardiac Fontan. This operation creates a tunnel outside the heart itself which reduces the chances of Fontan patients developing scar tissue on the heart which might later cause arrhythmias.

Prognosis

While infants successfully treated for HLHS have a good chance of survival, they may experience chronic health problems for the rest of their lives. The 3-stage surgeries were developed in the early 1980s with no survivors prior to that time. Therefore, the earliest survivors are in their mid 20s and the long term prognosis is unknown. However, the advances in surgical and medical techniques have helped increase the survival rate dramatically since the surgeries were first developed.

As is true for patients with other types of heart defects involving malformed valves, HLHS patients run a high risk of endocarditis, and must be monitored by a cardiologist for the rest of their lives to check on their heart function.

The three stage Norwood procedure only increases the life of the heart as HLHS cannot be cured. The child may need a heart transplant at some point in the child’s lifetime.

There is an extensive network of parents and children who have experienced this problem, and a number of targeted small press publications and websites.

Patients receiving the Fontan Procedure have an increased incidence of Plastic Bronchitis.

SSRI Antidepressant Heart Birth Defects

According to scientific studies, women who take SSRI Antidepressants such as Zoloft (sertraline), Paxil (paroxetine), Prozac (fluoxetine), Lexapro (escitalopram) and Celexa (citalopram) are at least twice as likely to give birth to children with serious congenital heart defects.  A congenital heart defect is a problem with the structure of the heart present at birth. Congenital heart defects are the most common type of major birth defect.  A baby’s heart begins to develop shortly after conception and during the first tri-mester. During development, structural defects can occur. These defects can involve the walls of the heart, the valves of the heart and the arteries and veins to and from the heart. Congenital heart defects can disrupt the normal flow of blood through the heart, lungs and body.

What is Total Anomalous Pulmonary Venous Return?

Total Anomalous Pulmonary Venous Return is a congenital heart disease (present at birth) in which none of the four veins that take blood from the lungs to the heart is attached to the left atrium (left upper chamber of the heart).

Causes

The cause of total anomalous pulmonary venous return (TAPVR) is unknown.  The US FDA has liked it to use of certain antidepressant medications during pregnancy

In normal circulation, blood is sent from the right ventricle to pick up oxygen in the lungs. It then returns through the pulmonary veins to the left side of the heart, which sends blood out through the aorta, and around the body.

In TAPVR, oxygenated blood returns from the lungs back to the right atrium or a vein flowing into the right atrium and NOT to the left side of heart. In other words, blood simply circles to and from the lungs and never gets out to the body.

If the infant is to live, a large atrial septal defect (ASD) or patent foramen ovale (passage between the left and right atria) must exist to allow oxygenated blood to flow to the left side of the heart and rest of the body.

The severity of this condition depends on whether the pulmonary veins are obstructed. Most often in obstructed TAVPR, the pulmonary veins run into the abdomen, passing through a muscle (diaphragm). This muscle squeezes the veins and narrows them, causing the blood to back up into the lungs. This type causes symptoms early in life and can be rapidly deadly if not recognized and surgically corrected.

Symptoms

The infant may appear to be critically ill and may display the following symptoms:

Lethargy
Poor feeding
Rapid breathing
Poor growth
Frequent respiratory infections
Cyanosis (blue discoloration of the skin)

Note: Sometimes, no symptoms may be present in infancy or early childhood.

Exams and Tests

ECG shows signs of enlargement of the ventricles (ventricular hypertrophy).
X-ray of the chest shows a normal to small heart with fluid in the lungs.
Echocardiogram usually defines the attachment of pulmonary vessels.
Cardiac catheterization can provide definitive diagnosis by showing abnormal attachments of the blood vessels.
MRI of the heart can show the connections between the pulmonary vessels.

Treatment

Early complete surgical repair is needed. In surgery, the pulmonary veins are connected to the left atrium and the defect between the right and left atrium is closed.

Outlook (Prognosis)

If left untreated, death may occur by age one in babies with more severe defects. With surgery, early repair provides excellent results if there is no blockage of the pulmonary veins at the new connection into the heart.

Possible Complications:

Heart failure
Breathing difficulties
Lung infections
Pulmonary hypertension
Irregular, fast heart rhythms (arrhythmias)

When to Contact a Medical Professional

This condition may be apparent at the time of birth. However, symptoms may not be present until later.

Prevention

There is no single known way to prevent TAPVR.  Many factors, including the use of antidepressant medications during pregnancy, seem to be involved.

Alternative Names

TAPVR

SSRI Class Action Lawsuit vs. Individual SSRI Lawsuit

There are distinct differences between an SSRI Antidepressant (Zoloft – sertraline, Paxil – paroxetine, Prozac – fluoxetine, Lexapro – escitalopram and Celexa – citalopram) class action lawsuit and a more typical individual SSRI lawsuit. A SSRI class action lawsuit would be a form of SSRI lawsuit in which a large group of people (plaintiffs) collectively bring a lawsuit to court in the form of a “class action” against the manufacturers of the SSRI antidepressant (defendant). In a class action lawsuit involving personal injury, resulting from defective products such as antidepressant SSRI drugs like Zoloft (sertraline), Paxil (paroxetine), Prozac (fluoxetine), Lexapro (escitalopram) and Celexa (citalopram), all SSRI lawsuit plaintiffs would typically be grouped together into a single SSRI class action lawsuit, regardless of the degree or severity of their birth defect injuries. In this type of SSRI class action lawsuit, plaintiffs with injuries ranging from minor heart murmurs not requiring surgery, all the way to the most severe congenital heart defects, requiring multiple surgeries or a complete heart transplant, would be grouped into one single SSRI class action lawsuit. All plaintiffs in the class would equally share any award or settlement resulting from the SSRI class action lawsuit.

In SSRI antidepressant lawsuits involving catastrophic injury or death, an individual lawsuit, in most cases, is more appropriate and in the plaintiff’s best interest. SSRI antidepressants like Zoloft, Prozac, Celexa, Lexapro and Paxil, have been linked to some of the severe congenital heart defects listed above, including: atrial septal defects (ASD – hole in the heart), ventricular septal defects (VSD – hole in the heart), tetrology of fallot (ToF), hypoplastic left heart syndrome (HLHS), transposition of the great arteries (TGA or TOGA), patent ductus arteriosus (PDA), total anomalous pulmonary venous return (TAPVR), double outlet right ventricle (DORV), and coarctation of the aorta (CoA). SSRI antidepressant cases such as these are better suited to an individual SSRI antidepressant lawsuit because of the severity and degree of injury to the plaintiff. In an individual SSRI lawsuit, each plaintiff’s case is filed, presented and considered individually, based on its own strength and degree of injury.

In many cases involving SSRI antidepressants like Zoloft, Prozac, Celexa, Lexapro, Paxil and the serious congenital heart defects related to these SSRI antidepressants, surgery is required. Heart surgery will typically be required when a child is an infant or toddler and then again, potentially multiple times, as the child grows to maturity. In many cases, with surgery and medical care, children may be able to lead mostly normal and productive lives. An individual SSRI lawsuit allows each SSRI victim, their injuries and their future needs to be considered on an individual basis when determining damages, awards and settlement amounts, and not as part of a class action lawsuit.

Speak to an SSRI Lawyer about an SSRI Birth Defect Lawsuit

If you took Prozac (fluoxetine), Paxil (paroxetine), Zoloft (sertraline), Celexa (citalopram), Lexapro (escitalopram) or any another SSRI antidepressant drug during pregnancy and your child was born with a congenital heart, lung or other birth defect, we encourage you to contact an SSRI Antidepressant Lawsuit Attorney at our law firm immediately. It may be too late to recover from the devastating effects of Prozac, Paxil, Zoloft, Lexapro and Celexa but an experienced pharmaceutical products liability lawyer at the Willis Law Firm can assist you in legal action against the makers of these dangerous antidepressant drugs. You are not alone. Join other birth defect victims and their families in speaking up and fighting for your legal rights.

Please fill out our free online legal evaluation form and we will contact you within 24 hours, or call our offices at 1-800-883-9858 for immediate help. Please keep in mind that certain states have statutes of limitation that limit the amount of time you have to file a lawsuit or seek legal action. Contact our law firm immediately so that we may explain the rights and options available to you and your family.

SSRI Antidepressant Heart Birth Defects

According to scientific studies, women who take SSRI Antidepressants such as Zoloft (sertraline), Paxil (paroxetine), Prozac (fluoxetine), Lexapro (escitalopram) and Celexa (citalopram) are at least twice as likely to give birth to children with serious congenital heart defects.  A congenital heart defect is a problem with the structure of the heart present at birth. Congenital heart defects are the most common type of major birth defect.  A baby’s heart begins to develop shortly after conception and during the first tri-mester. During development, structural defects can occur. These defects can involve the walls of the heart, the valves of the heart and the arteries and veins to and from the heart. Congenital heart defects can disrupt the normal flow of blood through the heart, lungs and body.

SSRI Antidepressant Lung Birth Defects

Persistent pulmonary hypertension of the newborn (PPHN) is one form of lung and respiratory birth defect that has been linked to the use of SSRI Antidepressants such as Zoloft (sertraline), Paxil (paroxetine), Prozac (fluoxetine), Lexapro (escitalopram) and Celexa (citalopram)  during pregnancy.  In the uterus, a baby’s circulation bypasses the lungs. When a baby is born and begins to breathe, its body normally transitions to the process of respiration.  PPHN occurs when a baby’s body doesn’t make the normal transition in circulation at birth, resulting in the circulation of un-oxygenated blood throughout the body.

Other SSRI Antidepressant Birth Defects

According to studies, there is an over 800% increased risk of giving birth to a child with Omphalocele when a woman has been prescribed and taken SSRI Antidepressants such as Zoloft (sertraline), Paxil (paroxetine), Prozac (fluoxetine), Lexapro (escitalopram) and Celexa (citalopram) during her pregnancy.  Omphalocele is an abdominal wall birth defect that occurs when an infant’s intestine or other abdominal organs protrude out of the navel. SSRI Antidepressant use during pregnancy has also been linked to cranio-facial malformations, as well as limb deformities and the birth defect known as Clubfoot.

Specific SSRI Antidepressant Birth Defect Side Effects

Atrial Septal Defects (ASD) –  A congenital heart defect in which the wall that separates the upper heart chambers does not close completely. Congenital means the defect is present at birth.  In fetal circulation, there is normally an opening between the two atria (the upper chambers of the heart) to allow blood to bypass the lungs. This opening usually closes around the time the baby is born.  If the ASD is persistent, blood continues to flow from the left to the right atria. This is called a shunt. If too much blood moves to the right side of the heart, pressures in the lungs build up.  For more detailed information follow the link to: Atrial Septal Defects (ASD)

Ventricular Septal Defects (VSD) –   A congenital heart defect in which one or more holes in the wall that separates the right and left ventricles of the heart occur.  It may occur by itself or with other congenital diseases.  Before a baby is born, the right and left ventricles of its heart are not separate. As the fetus grows, a wall forms to separate these two ventricles. If the wall does not completely form, a hole remains. This hole is known as a ventricular septal defect.  For more detailed information follow the link to: Ventricular Septal Defects (VSD).

Hypoplastic Left Heart Syndrome (HLHS) –  A rare type of congenital heart defect that develops before birth when there is not enough growth of the left ventricle and other structures, including: the Aorta — the blood vessel that carries oxygen-rich blood from the left ventricle to the entire body, the entrance and exit of the left ventricle, Mitral and aortic valves   For more detailed information follow the link to: Hypoplastic Left Heart Syndrome  (HLHS).

Tetralogy of Fallot (ToF) –  A congenital cyanotic heart defect causing low oxygen levels in the blood leading to cyanosis (a bluish-purple color to the skin).  It includes four related defects of the heart and its major blood vessels: Ventricular Septal Defect, Narrowing of the Pulmonary Outflow Tract, Overriding Aorta that is shifted over the right ventricle, and Right Ventricular Hypertrophy, a thickened muscular wall of the right ventricle.  For more detailed information follow the link to: Tetralogy of Fallot (ToF).

Transposition of the Great Arteries (TGA) –  A congenital heart defect in which the two major vessels that carry blood away from the heart — the aorta and the pulmonary artery — are transposed.  This is a cyanotic heart defect leading to cyanosis (a bluish-purple color to the skin) and shortness of breath.  In this defect, blood goes to the lungs, receives oxygen, and goes back to the lungs without going to the body.  Blood from the body returns to the heart and goes back to the body without ever picking up oxygen in the lungs. For more detailed information follow the link to: Transposition of the Great Arteries (TGA).

Patent Ductus Arteriosus (PDA) — A congenital heart condition where the ductus arteriosus fails to close after birth.  It leads to abnormal blood flow between the aorta and pulmonary artery.  Before birth, the ductus arteriosus allows blood to bypass the lungs by connecting the pulmonary arteries with the aorta. At birth, the lungs fill with air and this blood vessel is no longer needed and will usually close. If it does not close, abnormal blood circulation between the heart and lungs will occur.  For more detailed information follow the link to: Patent Ductus Arteriosus (PDA).

Total Anomalous Pulmonary Venous Return (TAPVR) — A congenital heart disease in which none of the four veins taking blood from the lungs to the heart is attached to the left atrium.  In normal circulation, blood is sent from the right ventricle to pick up oxygen in the lungs. It then returns through the pulmonary veins to the left side of the heart, which sends blood out through the aorta, to the body.  In TAPVR, oxygenated blood returns from the lungs to the right atrium and circles from the heart to the lungs and never out to the body.  For more detailed information follow the link to: Total Anomalous Pulmonary Venous Return (TAPVR).

Coarctation of the Aorta (CoA) — A congenital heart disease in which  narrowing of part of the aorta which blood to pass through the artery.  Aortic coarctation can also be due to birth defects of the aortic valves.  Many factors, including the use of antidepressant medications during pregnancy, seem to be involved.  Coarctation of the aorta may be seen with other congenital heart defects, such Bicuspid Aortic Valve, Ventricular Septal Defect, and defects in which only one ventricle is present.   For more detailed information follow the link to: Coarctation of the Aorta (CoA).

Other Congenital Heart Defects -  A congenital heart defect is any malformation or other problem with the structure of the heart that is present at birth. Congenital heart defects are the most common type of major birth defect and have many varieties and manifestations.  A baby’s heart begins to develop shortly after conception and during the first tri-mester. During development, structural defects can occur. These defects can involve the walls of the heart, the valves of the heart and the arteries and veins connecting to the heart. Congenital heart defects can disrupt the normal flow of blood through the infant’s heart, lungs and body.

Persistent Pulmonary Hypertension of the Newborn (PPHN) — A congenital pulmonary birth defect where a newborn does not receive necessary oxygen from the lungs.  In the womb, oxygen is supplied through the umbilical cord.  At birth, a baby’s system normally switches to receiving oxygen from its lungs. With PPHN, the heart, blood vessels, and lungs do not make that transition, and the blood does not interact with the lungs, but instead circulates as it did in the womb.  For more detailed information follow the link to: Persistent Pulmonary Hypertension of the Newborn (PPHN).

Omphalocele (an abdominal  wall birth defect) — A birth defect in which the newborn infant’s intestine or other abdominal organs protrude from the navel.  An omphalocele is a type of hernia or rupture.  An omphalocele develops as a baby grows inside the mother’s womb, when the muscles in the abdominal wall (umbilical ring) do not close properly.  As a result, the intestine remains outside the umbilical cord.  For more detailed information follow the link to: Omphalocele.

Craniosynostosis (cranial skull defect) — A congenital birth defect resulting in one or more sutures (areas separating individual skull bones) on a baby’s head closing earlier than normal, leading to an abnormally shaped head.  There are three types: Sagittal Synostosis, Frontal Plagiocephaly, and Metopic Synostosis.  These deformities may range from mild to severe.  For more detailed information follow the link to: Craniosynostosis.

Clubfoot — A congenital birth defect occuring when the foot turns inward and downward. It is the most common congenital disorder of the legs, and can range from mild and flexible to severe and rigid.  Many factors, including the use of antidepressant medications during pregnancy, also seem to be involved.  The physical appearance of the foot may vary. One or both feet may be affected.  The foot turns inward and downward at birth, and is difficult to place in the correct position. The calf muscle and foot may also be slightly smaller than normal.  For more detailed information follow the link to: Clubfoot.

SSRI Class Action Lawsuit vs. Individual SSRI Lawsuit

There are distinct differences between an SSRI Antidepressant (Zoloft – sertraline, Paxil – paroxetine, Prozac – fluoxetine, Lexapro – escitalopram and Celexa – citalopram) class action lawsuit and a more typical individual SSRI lawsuit. A SSRI class action lawsuit would be a form of SSRI lawsuit in which a large group of people (plaintiffs) collectively bring a lawsuit to court in the form of a “class action” against the manufacturers of the SSRI antidepressant (defendant). In a class action lawsuit involving personal injury, resulting from defective products such as antidepressant SSRI drugs like Zoloft (sertraline), Paxil (paroxetine), Prozac (fluoxetine), Lexapro (escitalopram) and Celexa (citalopram), all SSRI lawsuit plaintiffs would typically be grouped together into a single SSRI class action lawsuit, regardless of the degree or severity of their birth defect injuries. In this type of SSRI class action lawsuit, plaintiffs with injuries ranging from minor heart murmurs not requiring surgery, all the way to the most severe congenital heart defects, requiring multiple surgeries or a complete heart transplant, would be grouped into one single SSRI class action lawsuit. All plaintiffs in the class would equally share any award or settlement resulting from the SSRI class action lawsuit.

In SSRI antidepressant lawsuits involving catastrophic injury or death, an individual lawsuit, in most cases, is more appropriate and in the plaintiff’s best interest. SSRI antidepressants like Zoloft, Prozac, Celexa, Lexapro and Paxil, have been linked to some of the severe congenital heart defects listed above, including: atrial septal defects (ASD – hole in the heart), ventricular septal defects (VSD – hole in the heart), tetrology of fallot (ToF), hypoplastic left heart syndrome (HLHS), transposition of the great arteries (TGA or TOGA), patent ductus arteriosus (PDA), total anomalous pulmonary venous return (TAPVR), double outlet right ventricle (DORV), and coarctation of the aorta (CoA). SSRI antidepressant cases such as these are better suited to an individual SSRI antidepressant lawsuit because of the severity and degree of injury to the plaintiff. In an individual SSRI lawsuit, each plaintiff’s case is filed, presented and considered individually, based on its own strength and degree of injury.

In many cases involving SSRI antidepressants like Zoloft, Prozac, Celexa, Lexapro, Paxil and the serious congenital heart defects related to these SSRI antidepressants, surgery is required. Heart surgery will typically be required when a child is an infant or toddler and then again, potentially multiple times, as the child grows to maturity. In many cases, with surgery and medical care, children may be able to lead mostly normal and productive lives. An individual SSRI lawsuit allows each SSRI victim, their injuries and their future needs to be considered on an individual basis when determining damages, awards and settlement amounts, and not as part of a class action lawsuit.

Speak to an SSRI Lawyer about an SSRI Birth Defect Lawsuit

If you took Prozac (fluoxetine), Paxil (paroxetine), Zoloft (sertraline), Celexa (citalopram), Lexapro (escitalopram) or any another SSRI antidepressant drug during pregnancy and your child was born with a congenital heart, lung or other birth defect, we encourage you to contact an SSRI Antidepressant Lawsuit Attorney at our law firm immediately. It may be too late to recover from the devastating effects of Prozac, Paxil, Zoloft, Lexapro and Celexa but an experienced pharmaceutical products liability lawyer at the Willis Law Firm can assist you in legal action against the makers of these dangerous antidepressant drugs. You are not alone. Join other birth defect victims and their families in speaking up and fighting for your legal rights.

Please fill out our free online legal evaluation form and we will contact you within 24 hours, or call our offices at 1-800-883-9858 for immediate help. Please keep in mind that certain states have statutes of limitation that limit the amount of time you have to file a lawsuit or seek legal action. Contact our law firm immediately so that we may explain the rights and options available to you and your family.

Taking antidepressants in pregnancy may raise the risk of giving birth prematurely, researchers report. But left untreated, depression may also increase the chance of preterm birth, says researcher Katherine Wisner, MD, professor of psychiatry, ob-gyn, and women’s studies at the University of Pittsburgh Medical Center.

Each pregnant woman has to work with her doctor to weigh the benefits and risks of treatment with antidepressants known as selective serotonin reuptake inhibitors (SSRIs), she says. Premature birth has been linked to a host of health consequences, including learning disabilities, mental retardation, and cerebral palsy.

SSRIs include Prozac, Paxil, Lexapro, Celexa, and Zoloft.

The new study, presented at the annual meeting of the American Psychiatric Association, involved about 200 pregnant women. About half of them suffered from depression, and half of those women took SSRIs throughout pregnancy.

Results showed that 23% of those who took SSRIs throughout pregnancy gave birth to preterm babies. But so did 21% of those with depression who didn’t take SSRIs — a difference so small it could be due to chance.

In contrast, only 6% of women who did not have depression and didn’t take SSRIs had preterm babies.

According to Wisner, other research had shown that both depression and SSRIs can raise the risk for miscarriage. But taking antidepressants during pregnancy doesn’t greatly increase the overall risk of most birth defects, she says.

“This program is organized to include active participants from academia, the pharmaceutical industry, the regulatory Agency (FDA), and interested public persons. We welcome them to consider together the problems of drug-induced chemical injury to the liver, and how best we may work together to address, ameliorate, or solve those problems for the benefit of patients and consumers who are using products with medicinal effects.”

Subsequently, in a February 14, 2011 FDA Warning Letter published by the US Food and Drug Administration, the FDA warns patients and healthcare professionals of multiple instances of Multaq related cases of acute liver failure, which required liver transplants.

“[1-14-2011] The U.S. Food and Drug Administration (FDA) alerted healthcare professionals and patients about cases of rare, but severe liver damage, including two cases of acute liver failure leading to liver transplants in patients treated with the heart medication dronedarone (Multaq).”

If you or a loved one took the heart medication Multaq (dronedarone) and experienced liver toxicity, liver damage, acute hepatic failure or acute liver failure, please contact a Multaq Liver Damage Lawsuit Attorney at our law firm immediately. Fill out our free online legal evaluation form on the right side of this page and we will contact you within 24 hours, or call our offices at 1-800-883-9858 for immediate help.

Impact of Drug-Induced Liver Injury on Hepatology & Practice of Medicine

William M. Lee, MD
Professor of Medicine, University of Texas Southwestern Medical Center

Slide Presentation [PDF]

Abstract: Among the joys of good health are digestion of food and elimination of internally-derived toxins, functions primarily supplied by the gastrointestinal tract and kidneys respectively. However, the processing and excretion of all absorbed xenobiotics (foreign substances) is the province of the liver. Building upon, but exceeding in complexity, the functions of the gut and kidney, normal hepatic function is a third essential for good health. Drug reactions that interfere with hepatic function and are life-threatening are extremely rare, given the number of xenobiotics ingested. The marvel is that a single liver can and does metabolize as many as 12 drugs at a time without evidence of injury or even of buildup of any one of the various compounds ingested. As a result, patients and physicians assume (or take for granted) that the liver will perform its job faithfully with never a complaint.

Metabolism of xenobiotics involves the creation of activated intermediate compounds that rarely bind to cell proteins with subsequent hepatocyte damage, either directly or by invoking immune responses. The final result is often massive and sudden necrosis of liver cells, multi-organ failure and death. This rare but catastrophic event finds clinicians and patients unaware of the potential disaster and un-prepared to deal with a rapidly deteriorating situation. The likelihood of drug toxicity varies among individual agents and among drug classes. Many physicians are not familiar these varying propensities for drug toxicity. Even if they are aware of the possible consequences, physicians seldom give patients specific instructions that might be life-saving such as what to do should dark urine or jaundice develop. The very rarity of severe liver injury due to drugs represents its fundamental virtue and problem. We cannot develop an appropriate cost-effective response for events as infrequent as 1:50,000 prescriptions. How much instruction should a patient receive for such events? If a toxic reaction is recognized with a given agent, how much advertising in the post-marketing period should be directed at education of physicians to potential but rare events that seldom occur? Fear of drugs by physicians or patients limits their use. Withdrawal of drugs due to rare toxicity deprives patients of potential benefits. Caution, particularly in regard to drugs with known hepatotoxicity such as isoniazid, may lead to closer supervision, monitoring of liver function tests, or limitation of use to the least susceptible patients.

Physicians want to know how to avoid the risks and how to become educated regarding drug toxicity. They want safe drugs but realistically know that universal safety cannot be guaranteed. Yet they seldom participate in the efforts to monitor drug reactions; adverse events are reported to FDA less than 10% of the time. Improved methods of post-marketing surveillance should result in more rapid identification of potential toxins whose initial clinical assessments did not identify drug events. Education directed at recognition of the symptoms of acute liver failure might lead to earlier withdrawal of toxins and prompt institution of intensive care.

The three constituencies represented at this conference should dedicate their efforts to greater education of physicians and patients concerning drug toxicity and severe liver injury with the goal of identifying harmful effects more reliably and preventing these potentially avoidable events.

Speak to a Multaq Lawyer about a Multaq Liver Failure Lawsuit

If you or a loved one took the heart medication Multaq (dronedarone) and experienced liver damage, liver toxicity, acute hepatic failure or acute liver failure, please contact a Multaq Liver Failure Lawsuit Attorney at our law firm immediately. It may be too late to recover from the devastating effects of Multaq, but an experienced pharmaceutical products liability lawyer at the Willis Law Firm can assist you in legal action against Sanofi-Aventis SA, the maker of this dangerous drug. You are not alone. Join other liver failure victims and their families in speaking up and fighting for your legal rights.

Please fill out our free online legal evaluation form and we will contact you within 24 hours, or call our offices at 1-800-883-9858 for immediate help. Please keep in mind that certain states have statutes of limitation that limit the amount of time you have to file a lawsuit or seek legal action. Contact our law firm immediately so that we may explain the rights and options available to you and your family.

You may have viewed a recent Topamax Lawsuit commercial airing as a TV ad to alert the television viewing public of the Topamax FDA Warning regarding the possible link between Topamax (topiramate) and cleft palate and cleft lip lawsuits. While this was not a Topamax Recall commercial, since Topamax has not at present been the subject of an official Topamax FDA Recall, this Topamax Lawsuit TV ad presents relevant Topamax (topiramate) lawsuit information on TV regarding Topamax (topiramate) use and possible Topamax cleft palates, cleft lips and other oral or cranio-facial birth deformities.

For more information: Topamax Cleft Palate Lawsuits

Topamax Cleft Palate Cleft Lip TV Ad

If you have an opportunity to view this Topamax (topiramate) Lawsuit TV advertisement, please pay close attention and decide if the Topamax cleft palate and cleft lip birth defect side effects described in the Topamax (topiramate) Lawsuit TV commercials apply to you or a loved one.  Again, potential Topamax lawsuits referenced in this Topamax Lawsuit TV commercial included those regarding Topamax cleft palate and cleft lip oral birth defects. Please call our law firm at 1-800-883-9858 to speak to a Topamax lawsuit lawyer. A Topamax attorney at the Willis Law Firm in Houston, Texas can help explain your legal rights and options in filing a Topamax Cleft Palate Lawsuit.

Topamax Class Action Lawsuit Commercial (TV Ad)

There are significant differences between Topamax Class Action Lawsuits and an individual Topamax Lawsuit. In a Topamax cleft palate – cleft lip class action lawsuit, a large group of plaintiffs would form a “class” and collectively bring their suit to court against a defendants, Johnson & Johnson (JNJ) and Ortho-McNeil Pharmaceutical LLC, the makers of Topamax. In a class action lawsuit, all potential Topamax cleft palate cleft lip plaintiffs would be grouped into a single Topamaxcleft palate cleft lip class action lawsuit, regardless of severityof their oral cleft injuries. Plaintiffs in a Topamax Class Action Lawsuit would then share any resulting settlement or award from the Topamax cleft palate class action lawsuit.

Topamax lawsuits involving catastrophic injury would typically be better served by filing an individual lawsuit.  In an individual Topamax Cleft Palate lawsuit, each plaintiff’s case is filed, presented, reviewed and argued individually, solely on its own merit, strength and degree of cranio-facial birth defect injury.

An individual Topamax Cleft Palate Lawsuit allows each Topamax cleft palate birth defect victim to have their case presented and considered on an individual basis when determining damages, awards and settlement figures, based on an individual victim’s personal oral cleft injuries and future needs, and not as part of a grouped class action lawsuit.

Speak to a Topamax Lawyer

If you took Topamax (topiramate) or any other anti-seizure drug during pregnancy and your child was born with a cleft palate, cleft lip or any other congenital cranio-facial birth defect, we encourage you to contact a Topamax Litigation Attorney at our law firm immediately. It may be too late to recover from all of the devastating effects of Topamax but an experienced products liability pharmaceutical lawsuit lawyer at the Willis Law Firm can assist you in legal action against Johnson & Johnson (JNJ) and Ortho-McNeil Pharmaceutical LLC, the makers of Topamax. You are not alone. Join other birth defect victims and their families in speaking up and fighting for your legal rights.

Topamax Cleft Palate Lawsuit

Please fill out our free online legal evaluation form and we will contact you within 24 hours. Please keep in mind that certain states have statutes of limitation that limit the amount of time you have to file a lawsuit or seek legal action. Contact our law firm immediately so that we may explain the rights and options available to you and your family.

You may have viewed a recent Multaq lawsuit commercial airing as a TV ad to alert the television viewing public of the Multaq FDA Warning regarding the possible link between Multaq (sometimes pronounced Multag) and liver damage, liver failure, acute liver failure and acute hepatic failure lawsuits. While this was not a Multaq Recall commercial, since Multaq has not at present been the subject of an official Multaq FDA Recall, this Multaq lawsuit TV ad presents relevant Multaq lawsuit information on TV regarding Multaq use and possible Multaq liver damage, liver failure, acute liver failure and acute hepatic failure, which may even result in the need for a liver transplant or other serious liver surgery.

For more information: Multaq Liver Failure Lawsuits

If you see this Multaq lawsuit TV advertisement, please pay close attention and decide if the Multaq liver damage side effects described in the Multaq lawsuit TV commercials apply to you or a loved one.   Again, potential Multaq lawsuits referenced in this Multaq lawsuit TV commercial included those regarding Multaq liver damage, liver failure, acute liver failure and acute hepatic failure. Please call our law firm at 1-888-LAW-2040 to speak to a Multag lawsuit lawyer. A Multaq attorney at the Willis Law Firm in Houston, Texas can help explain your legal rights and options in filing a Multaq liver failure lawsuit.

Multaq Class Action Lawsuit Commercial (TV Ad)

There are significant differences between Multaq class action lawsuits and an individual Multaq lawsuit. In a Multaq liver failure class action lawsuit, a large group of plaintiffs would form a “class” and collectively bring their lawsuit to court against a defendant, in this case, Sanofi-Aventis. In a class action lawsuit, all potential Multaq liver failure plaintiffs would be grouped into a single Multaq liver failure class action lawsuit, regardless of severity liver injuries. Plaintiffs in a Multaq class action lawsuit would then share any resulting settlement or award from the Multaq liver failure class action lawsuit.

Multaq lawsuits involving catastrophic injury or death would typically be better served by filing an individual lawsuit.  In an individual Multaq liver damage lawsuit, each plaintiff’s case is filed, presented, reviewed and argued individually, solely on its own merit, strength and degree of liver injury.

An individual Multaq liver failure lawsuit allows each Multaq liver failure victim to have their case presented and considered on an individual basis when determining damages, awards and settlement figures, based on an individual victim’s personal liver injuries and future needs, and not as part of a grouped class action lawsuit.

Speak to a Multaq Lawyer about a Multaq Liver Failure Lawsuit

If you or a loved one have taken the heart medication Multaq (dronedarone) and experienced acute hepatic failure, liver damage or acute liver failure please contact a Multaq Liver Failure Lawsuit Attorney at our law firm immediately. While it may be too late to completely recover from the devastating effects of Multaq, a products liability lawyer who is skilled and experienced in pharmaceutical litigation and FDA Recall drugs at the Willis Law Firm can assist you in legal action against Sanofi-Aventis SA, the maker of Multaq. You are not alone. Join other liver failure victims and their families in speaking up and fighting for your legal rights.

Please fill out our free online legal evaluation form and we will contact you within 24 hours, or call our offices at 1-800-883-9858 for immediate help. Please keep in mind that certain states have statutes of limitation that limit the amount of time you have to file a lawsuit or seek legal action. Contact our law firm immediately so that we may explain the rights and options available to you and your family.