The Lancet

Volume 375, Issue 9716, Pages 735 – 742, 27 February 2010

Prof Naveed Sattar PhD a , Dr David Preiss MRCP a , Heather M Murray MSc b, Paul Welsh PhD a, Prof Brendan M Buckley FRCPI c, Anton JM de Craen PhD d, Sreenivasa Rao Kondapally Seshasai MD e, Prof John J McMurray MD a, Dilys J Freeman PhD f, Prof J Wouter Jukema MD g, Prof Peter W Macfarlane DSc h, Prof Chris J Packard DSc h, Prof David J Stott MD h, Prof Rudi G Westendorp MD i, Prof James Shepherd MD h, Prof Barry R Davis PhD j, Sara L Pressel MS j, Prof Roberto Marchioli MD k, Prof Rosa Maria Marfisi MS k, Prof Aldo P Maggioni MD l, Prof Luigi Tavazzi MD m, Prof Gianni Tognoni MD k, Prof John Kjekshus MD n, Prof Terje R Pedersen MD o, Thomas J Cook MS p, Prof Antonio M Gotto MD q, Prof Michael B Clearfield DO r, John R Downs MD s, Prof Haruo Nakamura MD t, Prof Yasuo Ohashi MD u, Prof Kyoichi Mizuno MD v, Kausik K Ray MD e, Prof Ian Ford PhD

 Summary  Background

Trials of statin therapy have had conflicting findings on the risk of development of diabetes mellitus in patients given statins. We aimed to establish by a meta-analysis of published and unpublished data whether any relation exists between statin use and development of diabetes.

Methods

We searched Medline, Embase, and the Cochrane Central Register of Controlled Trials from 1994 to 2009, for randomised controlled endpoint trials of statins. We included only trials with more than 1000 patients, with identical follow-up in both groups and duration of more than 1 year. We excluded trials of patients with organ transplants or who needed haemodialysis. We used the I2 statistic to measure heterogeneity between trials and calculated risk estimates for incident diabetes with random-effect meta-analysis.

Findings

We identified 13 statin trials with 91 140 participants, of whom 4278 (2226 assigned statins and 2052 assigned control treatment) developed diabetes during a mean of 4 years. Statin therapy was associated with a 9% increased risk for incident diabetes (odds ratio [OR] 1·09; 95% CI 1·02—1·17), with little heterogeneity (I2=11%) between trials. Meta-regression showed that risk of development of diabetes with statins was highest in trials with older participants, but neither baseline body-mass index nor change in LDL-cholesterol concentrations accounted for residual variation in risk. Treatment of 255 (95% CI 150—852) patients with statins for 4 years resulted in one extra case of diabetes.

Interpretation

Statin therapy is associated with a slightly increased risk of development of diabetes, but the risk is low both in absolute terms and when compared with the reduction in coronary events. Clinical practice in patients with moderate or high cardiovascular risk or existing cardiovascular disease should not change.

Speak to a Crestor Lawyer about a Crestor Lawsuit

If you or a loved one took the cholesterol drug Crestor (Rosuvastatin) and experienced heart failure, stroke, diabetes, 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.

Prolonged exposure to cold therapy, ice machines, recirculating ice coolers, cryotherapy and other forms of cold treatment may cause skin damage, permanent nerve damage, frostbite, and chronic pain to patients. In some cases, this severe damage may even be caused by as little as one (1) hour of continuous contact with a cold therapy unit. 

Certain Cold Therapy Units have been the subject of an August 20, 2008 Cold Therapy Machine - Cryotherapy FDA Recall.  A case report entitled, Cryotherapy Can Cause Permanent Nerve Damage : A Case Report , was published in the American Journal of Pain Management in April of 2004. The case study describes the cold therapy side effects of a patient who had undergone repetitive and prolonged cryotherapy (application of ice), and cryosurgery (cryoablation).

Cold Therapy Side Effects

Cold therapy side effects may include one or more of the following:

• Skin damage
• Nerve damage
• Frostbite
• Wrist, ankle, shoulder or back injury
• Hand amputation
• Foot amputation
• Loss of a limb
  • Arm amputation
  • Leg amputation
• Complex Regional Pain Syndrome (CRPS)
  • CRPS 1 (chronic nerve disorder in the arms or legs after a minor injury)
  • CRPS 2 (caused by an injury to the nerve)
• Reflex Sympathetic Dystrophy (RSD)
  • Reflex Sympathetic Dystrophy Syndrome (RSDS)
  • Complex Regional Pain Syndrome
  • Shoulder-Hand Syndrome
  • Causalgia
  • Sudeck’s Atrophy

Cold Therapy Machines Under Investigation

Chronic pain and permanent nerve damage resulting from exposure to cold therapy, ice machines, recirculating ice coolers, cryotherapy and other forms of cold treatment are why numerous consumers are filing cold therapy lawsuits. Several manufacturers of cold therapy machines are being investigated for defective crynotherapy equipment and design flaws that may have caused cold therapy injuries to patients. Some if these cold therapy devices include:

• DonJoy Cold Therapy Machines
• PolarCare Cold Therapy Machines
• EBIce Cold Therapy Machines

Cold therapy lawsuits are being filed by lawyers representing victims injured by these defective products. Cold therapy lawsuits claim that the cold therapy machines were defective in their design by not having adequate safety mechanisms to prevent injury. Cold machine lawsuits also claim these devices fail to adequately warn consumers of the risks involved with extended or prolonged use of their product.

For more information regarding cold therpy lawsuits, please fill out our form on the right side of this page or give our law firm a call at our toll free number 1-800-883-9858.

Cold Therapy Attorney

Poorly designed cold therapy machines may cause permanent skin damage (frost bite), nerve damage, and numerous other serious side effects. Seek immediate medical attention if you are suffering an emergency situation.

If you or someone you know has been severely injured as a result of cold therapy, ice machines, recirculating ice coolers, cryotherapy or other forms of cold treatment, talk to a Cold Therapy Attorney at the Willis Law Firm in Houston for legal advice about a potential cold therapy lawsuit.  Please fill out the Free Case Evaluation to the right or call us toll-free at 1-800-883-9858.

Prozac During PregnancyLawsuits are currently being pursued for women who took Prozac during pregnancy and had children born with cardiac and other serious congenital birth defects.  These defects have been potentially linked to use of the anti-depressant drug Prozac during pregnancy. Research suggests serious  side effects from use of SSRI antidepressants like Prozac (fluoxetine) during pregnancy, including increased risk of congenital heart defects and other congenital birth defects resulting from women taking Prozac during pregnancy. The potential link between Prozac and congenital heart defects has many professionals concerned about pregnant women being prescribed the antidepressant medication Prozac, and taking Prozac during pregnancy. SSRIs like Zoloft, Prozac, Celexa and Paxil have also been linked to increased risk of Persistent Pulmonary Hypertension of the Newborn (PPHN).

What is Prozac?

Prozac (fluoxetine) 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. Prozac affects chemical levels in the brain which may become unbalanced and create symptoms. Prozac during pregnancy 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, with Prozac during pregnancy being the number one seller.

Prozac during pregnancy and other SSRIs during pregnancy have been linked to serious side effects, including increased risk of congenital heart defects, Persistent Pulmonary Hypertension of the Newborn (PPHN) and documented serious withdrawal symptoms.

Health Canada advised of potential adverse effects of SSRIs and other anti-depressants on newborns, specifically fluoxetine (Prozac)in 2004. This was intended to increase awareness among mothers and physicians of possible symptoms and side effects occurring in newborns, so that symptoms could be recognized and addressed quickly.

When the Food and Drug Administration (FDA) approved Prozac (fluoxetine) in 1998, it became the most widely prescribed drug for depression on the market.  A 1996 study published in the New England Journal of Medicine, two years before the FDA approval, revealed that women taking Prozac during pregnancy were two times as likely to deliver a baby with three or more abnormalities and poorer than average neonatal adaptation.

Prozac Heart Defects

Taking SSRI antidepressants like Zoloft, Paxil, Celexa, Lexapro and Prozac during pregnancy has been linked to cases of serious congenital heart defects, which may include atrial septal defects (ASD – Hole in 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).   With these birth defects, in many cases, surgery is required when a child is an infant or toddler and then again, potentially multiple times, as the child grows to maturity. Many congenital heart defects are treatable when they are diagnosed and addressed early.  Children may be able to lead mostly normal and productive lives following medical attention.  However, in some cases the only viable option to  preserve the child’s life and correct these severe heart defects involves a heart transplant. 

A Danish study in 2005  indicated that pregnant women prescribed SSRI antidepressant medicines like Prozac during pregnancy may have an increased risk of giving birth to infants with congenital heart problems.  Based on this study, newborns exposed to SSRI antidepressants like Prozac, Zoloft, Celexa and Paxil during the first 3 months of pregnancy had a 60 percent higher probability of developing congenital heart defects when compared with infants whose pregnant mothers did not take SSRI antidepressants lie Prozac during pregnancy.

In the Diav-Citrin Study it was shown that Prozac during pregnancy increases the risk of Cardiovascular defects four and a half times and doubles the risk of major abnormalities overall. If you or a loved one has suffered from a birth defect that you believe was caused by an SSRI please contact us immediately.

There is also a strong link between SSRI antidepressants like Prozac during pregnancy and other congenital birth defects and malformations, including lung, cranio-facial, limb (arm, hand, leg, foot) and abdominal wall defects. A study conducted at Aarhus University Hospital, Denmark, revealed that the risk of pregnant women giving birth to babies with congenital birth defects, including heart and other defects, was higher among women who had been prescribed and taken SSRIs such as Prozac during pregnancy and in the month prior to conception, compared with those who had no SSRI prescriptions filled during the same period. The Alwan 2007 study showed an almost three times increased risk of Craniosynostosis, which is when the plates of the skull prematurely fuse. The Alwan study also showed an increased risk associated with SSRI’s as a group, for Anencephaly, Craniosynostosis and Omphalocele.

Women who are taking SSRI antidepressants, including Prozac, who are pregnant or thinking about becoming pregnant should speak with their doctor about the risks associated with taking SSRIs like Prozac during pregnancy. There are risks associated with taking Prozac during pregnancy.  There may also be concerns about discontinuing prozac during pregnancy. All Birth Defect risks should be discussed with a physician and balanced against any possible benefits of taking this medication during pregnancy.

Prozac Class Action Lawsuit vs. Individual Prozac Lawsuit

There are distinct differences between a Prozac (fluoxetine) class action lawsuit and a more typical individual Prozac lawsuit. A Prozac class action lawsuit would be a form of Prozac 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 Prozac (defendant). In a class action lawsuit involving personal injury resulting from defective products such as antidepressant SSRI drugs like Prozac (fluoxetine), Paxil (paroxetine), Zoloft (sertraline), Lexapro (escitalopram) and Celexa (citalopram), all Prozac lawsuit plaintiffs would typically be grouped together into a single Prozac class action lawsuit, regardless of the degree or severity of their birth defect injuries. In this type of Prozac 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 Prozac class action lawsuit. All plaintiffs in the class would equally share any award or settlement resulting from the Prozac class action lawsuit.

In Prozac during pregnancy 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 Prozac, Celexa, Lexapro, Paxil and Zoloft have been linked to severe congenital heart defects, 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). Prozac cases such as these are better suited to an individual Prozac lawsuit because of the severity and degree of injury to the plaintiff. In an individual Prozac 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 Prozac, Celexa, Lexapro, Paxil and Zoloft 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 Prozac lawsuit allows each Prozac 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.

SSRI Lawsuits

• Celexa Lawsuit
• Paxil Lawsuit
• Prozac Lawsuit
• Zoloft Lawsuit

Speak to a Prozac Lawsuit Lawyer about Filing a Prozac Lawsuit

Call and speak to a Prozac During Pregnancy Lawsuit attorney if you took Prozac or generic fluoxetine during pregnancy and your child was born with a birth defect.  We encourage you to contact a Prozac lawsuit attorney at our law firm immediately. It may be too late to avoid the debilitating effects of Prozac, but an experienced Prozac lawsuit products liability attorney at the Willis Law Firm can assist you in filing a Prozac lawsuit and taking legal action against the manufacturer of Prozac. You are not alone. Join other birth defect victims and their families in speaking up for and fighting for your legal rights with a Prozac 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 Prozac 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 in filing a Prozac lawsuit.

Zoloft During PregnancyLawsuits are currently being pursued for women who took Zoloft during pregancy and had children born with cardiac and other serious congenital birth defects.  These defects have been potentially linked to use of the anti-depressant drug Zoloft during pregnancy. Research suggests serious Zoloft (sertraline) side effects, including increased risk of congenital heart defects and other congenital birth defects resulting from women taking Zoloft during pregnancy. The link between Zoloft (sertraline) and congenital heart defects has many professionals concerned about pregnant women being prescribed the antidepressant medication Zoloft, and taking Zoloft during pregnancy. SSRIs like Zoloft, Prozac, Celexa and Paxil have also been linked to increased risk of Persistent Pulmonary Hypertension of the Newborn (PPHN).

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.  One of the SSRI drugs most prescribed is Zoloft during pregnancy. 

Zoloft during pregnancy as well as other SSRIs have been linked to serious side effects, including increased risk of congenital heart defects, Persistent Pulmonary Hypertension of the Newborn (PPHN) and documented serious withdrawal symptoms.

Health Canada advised of potential adverse effects of SSRIs like Zoloft during pregnancy, as well as other anti-depressants on newborns, including sertraline (brand name: Zoloft) in 2004. This report was intended to increase awareness among mothers and physicians of possible symptoms and side effects occurring in newborns linked to mothers who took Zoloft during pregnancy, so that symptoms could be recognized and addressed quickly.

When the Food and Drug Administration (FDA) approved Zoloft (sertraline), it became one of the most widely prescribed drugs for depression on the market. A 1996 study published in the New England Journal of Medicine revealed that women taking SSRIs like Zoloft during pregnancy were two times as likely to deliver a baby with three or more abnormalities and poorer than average neonatal adaptation.

Zoloft Heart Defects

Taking SSRI antidepressants like Prozac, Celexa, Paxil and Zoloft during pregnancy has been linked to cases of serious congenital heart defects in babies of women who took Zoloft during pregnancy, which may include 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). In many cases, surgery is required when a child is an infant or toddler and then again, potentially multiple times, as the child grows to maturity. Many congenital heart defects potentially caused by Zoloft during pregnancy are treatable when they are diagnosed and addressed early. Children may be able to lead mostly normal and productive lives following medical attention. However, in some cases the only viable option to preserve the child’s life and correct these severe heart defects involves a heart transplant.

A Danish study in 2005 indicated that pregnant women prescribed SSRI antidepressant medicines like Zoloft in early pregnancy may have an increased risk of giving birth to infants with congenital heart problems. Based on this study, newborns exposed to SSRI antidepressants like Zoloft, Prozac, Celexa and Paxil during the first 3 months of pregnancy had a 60 percent higher probability of developing congenital heart defects when compared with infants whose pregnant mothers did not take Zoloft during pregnancy or other SSRI antidepressants during pregnancy.

There is also a strong link between SSRI antidepressants like Zoloft during pregnancy and other congenital birth defects and malformations, including lung, cranio-facial, limb (arm, hand, leg, foot) and abdominal wall defects. A study conducted at Aarhus University Hospital, Denmark, revealed that the risk of pregnant women giving birth to babies with congenital defects, including heart and other defects, was higher among women who had been prescribed and taken SSRIs such as Zoloft during pregnancy in the month prior to conception through the end of their first trimester when compared with those who had no SSRI prescriptions filled and did not take Zoloft during pregnancy in the same period.

Women who are taking SSRI antidepressants, including Zoloft during pregnancy, or who are thinking about becoming pregnant should speak with their doctor about the risks associated with taking Zoloft during pregnancy, or any other SSRI antidepressant while pregnant. There are risks associated with taking Zoloft during pregnancy. There may also be concerns about discontinuing Zoloft during pregnancy. All Birth Defect risks should be discussed with a physician and balanced against any possible benefits of taking this medication during pregnancy.

Zoloft Class Action Lawsuit vs. Individual Zoloft Lawsuit

There are distinct differences between a Zoloft (sertraline) class action lawsuit and a more typical individual Zoloft lawsuit. A Zoloft class action lawsuit would be a form of Zoloft 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 Zoloft (defendant). In a class action lawsuit involving personal injury, resulting from defective products such as antidepressant SSRI drugs like Zoloft during pregnancy, Paxil during pregnancy, Prozac  during pregnancy and Celexa  during pregnancy, all Zoloft lawsuit plaintiffs would typically be grouped together into a single Zoloft class action lawsuit, regardless of the degree or severity of their birth defect injuries resulting from Zoloft during pregnancy. In this type of Zoloft 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 Zoloft class action lawsuit. All plaintiffs in the class would equally share any award or settlement resulting from the Zoloft class action lawsuit.

In Zoloft lawsuits involving catastrophic injury or death resulting from Zoloft during pregnancy, an individual lawsuit, in most cases, is more appropriate and in the plaintiff’s best interest. SSRI antidepressants like Prozac, Celexa, Paxil and Zoloft during pregnancy have been linked to severe congenital heart defects, 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). Zoloft cases such as these are better suited to an individual Zoloft lawsuit because of the severity and degree of injury to the plaintiff from Zoloft during pregnancy. In an individual Zoloft 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 Prozac, Celexa, Paxil, and Zoloft during pregnancy may be linked to 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 Zoloft lawsuit allows each victim of Zoloft during pregnancy, 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.

SSRI Lawsuits

• Celexa Lawsuit
• Paxil Lawsuit
• Prozac Lawsuit
• Zoloft Lawsuit

Speak to a Zoloft Lawsuit Lawyer about Filing a Zoloft Lawsuit

Call and speak to a Zoloft lawsuit attorney if you took Zoloft during pregnancy or took generic sertraline during pregnancy and your child was born with a birth defect. We encourage you to contact a Zoloft lawsuit attorney at our law firm immediately. It may be too late to avoid the debilitating effects of Zoloft during pregnancy, but an experienced Zoloft lawsuit products liability attorney at the Willis Law Firm can assist you in filing a Zoloft lawsuit and taking legal action against the manufacturer of Zoloft. You are not alone. Join other Zoloft birth defect victims and their families in speaking up for and fighting for your legal rights with a Zoloft 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 Zoloft 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.

(Reuters) - Lisa Richwine – WASHINGTON - Fri Feb 5, 2010 1:34pm EST

The risk of a potentially fatal brain disorder (PML) with Biogen Idec Inc’s multiple sclerosis drug Tysabri increases as patients receive more infusions, U.S. health officials warned on Friday.

The prescribing instructions for Tysabri will be updated to warn of the higher risk with more treatment, the Food and Drug Administration said. Elan Corp co-markets the drug.

The FDA said the warning was based on 31 confirmed cases of progressive multifocal leukoencephalopathy (PML), a brain infection that can be fatal. Eight patients have died.

“Based on the available information, the FDA believes that the clinical benefits of Tysabri continue to outweigh the potential risks,” the FDA said in a notice on its website.

Tysabri was temporarily withdrawn from the market in 2005 because of its link to PML.

Biogen spokeswoman Naomi Aoki said “there was nothing I thought was new” in the FDA notice.

“Either it was included as part of our last label update or it was information that we are making available on a monthly basis,” she said.

Biogen updates the number of PML cases each month to doctors on request but no longer posts the figure on its website or issues a press release.

Elan officials were not immediately available for comment.

Tysabri is given as a single infusion every four weeks. About 66,000 people worldwide have been treated with the drug since it reappeared on the market in 2006, the FDA said.

The PML rate for patients given at least one infusion is 0.5 cases per 1,000 patients, the FDA said. For patients given at least 24 infusions, the PML rate is 1.3 per 1,000.

The FDA move comes two weeks after a similar announcement by European regulators, who also said Tysabri’s benefits outweighed risks.

The drug carries a boxed warning, the strongest type for prescription drugs, about the PML risk. All patients must enroll in a monitoring program for PML or other serious infections called: “The Touch Program”. The drug’s generic name is natalizumab.

Tysabri PML Lawyer

If you or a family member has been diagnosed with PML, or been treated with Tysabri infusions, contact our law firm to speak to a PML lawyer about your legal options. Our law firm is dedicated to fighting for the rights of those that have been harmed by dangerous and recalled drugs and medical devices. For over 25 years, Attorney David Willis has been a trial lawyer representing seriously injured clients in product liability and personal injury lawsuits such as defective drug litigation, class action drug lawsuits and medical device recall lawsuits. If Tysabri has harmed you, or a loved one, contact us right now to discuss your potential case in filing a Tysabri PML Lawsuit.

What is Double Outlet Right Ventricle (DORV)?

Double outlet right ventricle (DORV) is a form of congenital heart disease where both of the great arteries connect (in whole or in part) to the right ventricle (RV). In double outlet right ventricle (DORV) the aorta rises from the right ventricle (the chamber of the heart that pumps blood to the lungs), instead of from the left ventricle (the normal pumpng chamber to the body). Both the pulmonary artery (which carries oxygen-poor blood to the lungs) and aorta (which carries oxygen-rich blood from the heart to the body) come from the same pumping chamber. No arteries arise from the left ventricle (the normal pumping chamber to the body).

There are several types of DORV. The difference between types is the location of the VSD compared to the location of the pulmonary artery and aorta. The type of DORV, and the presence or absence of pulmonary valve stenosis, affect the severity of signs and symptoms the baby may have.

Causes of Double Outlet Right Ventricle

Normally, the aorta arises from the left ventricle (the chamber of the heart that usually pumps blood to the body). The pulmonary artery normally arises from the right ventricle. In DORV, both arteries arise from the right ventricle. This is a problem because the right ventricle carries oxygen-poor blood, which the aorta then carries throughout the body. DORV always includes a ventricular septal defect (VSD). Pulmonary valve stenosis or transposition of the great arteries may also be part of the defect.

The presence of a VSD helps the infant with DORV, because oxygen-rich blood from the lungs flows from the left side of the heart, through the VSD opening and into the right chamber, mixing with the oxygen-poor blood. However, the body may still not get enough oxygen even with this mixture, and the heart has to work harder to try to bring more oxygen-rich blood to the body. In addition, because the pulmonary artery receives blood from both ventricles instead of just the right one, blood pressure in the lungs increases. Patients with DORV often have other heart abnormalities such as:

•Anomalous coronary arteries

•Coarctation of the aorta

•Mitral valve problems

•Pulmonary atresia

•Pulmonary valve stenosis

•Right aortic arch

•Transposition of the great arteries

Symptoms of Double Outlet Right Ventricle

•Baby tires easily, especially when feeding

•Bluish skin color (the lips may also be blue)

•Clubbing (thickening of the nail beds) on toes and fingers (late sign)

•Failure to gain weight and grow

•Pale coloring

•Sweating

•Swollen legs or abdomen

•Trouble breathing

•Enlarged heart

•Heart murmur

•Rapid breathing

•Rapid heartbeat

Exams and Tests for Double Outlet Right Ventricle

•Chest x-rays

•Passing a thin, flexible tube into the heart to measure blood pressure and inject dye for special pictures of the heart and arteries (cardiac catheterization)

•Ultrasound exam of the heart (echocardiogram)

•Using magnets to create images of the heart (MRI)

Treatment of Double Outlet Right Ventricle

Treatment requires surgery to close the holes in the heart. Surgery may also be needed to fix other existing problems in the heart. Several factors determine the type and number of operations the baby may need, including:

•The type of DORV

•The severity of the defect

•The presence of other problems in the heart

•The child’s overall condition

If pulmonary stenosis is not present, double outlet right ventricle may be repaired in one operation. The surgeon will repair the VSD, but build a conduit through it to connect the left ventricle to the aorta. This technique is known as the Rastelli procedure. Other surgeons may opt for the arterial switch operation (or Jatene), commonly also used with transposition of the great arteries, in which the aorta is reconnected to the left ventricle. The surgical technique will depend upon the several factors: the location of the VSD and its relationship to the aortic and pulmonary valves, the presence or absence of pulmonary stenosis, and the distribution of the coronary arteries. There are also factors such as A-V discordance, size of the right ventricle, and the straddling of A-V valves.

Outlook (Prognosis) of Double Outlet Right Ventricle

How well the baby does depends on several factors, including:

•The size of the VSD

•Its location

•The size of the pumping chambers

•The location of the aorta and pulmonary artery

•The presence of additional complications (such as coarctation of the aorta and mitral valve problems)

•The baby’s overall health at the time of diagnosis

•Whether irreversible lung damage has occurred

Possible Complications of Double Outlet Right Ventricle

•Congestive heart failure (CHF)

•High blood pressure in the lungs

•Irreversible damage to the lungs due to untreated high blood pressure in the lungs

•All children with this congenital heart disease should take antibiotics before dental treatment to prevent infections of the heart.

When to Contact a Medical Professional about the posibility of Double Outlet Right Ventricle

Call your health care provider if your child seems to tire easily, has trouble breathing, or has bluish skin or lips. You should also consult your health care provider if your baby is not growing or gaining weight.

Alternative Names for Double Outlet Right Ventricle

DORV; Taussig-Bing anomaly; DORV with doubly-committed VSD; DORV with noncommitted VSD; DORV with subaortic VSD

Depakote, a widely used anti-epileptic and anti-seizure drug, is manufactered and marketed by Abbott Laboratories. Depakote was first approved by the US FDA and introduced in the US market in 1983.  Until 1995, Depakote was primarily used to treat the seizures associated with epilepsy.  In 1995 it was approved to treat the manic episodes associated with bi-polar disorder or manic depression. Depakote was used to treat the long-term manic and depressive parts of rapidly-cycling bipolar disorder. After positive results in treating manic depression, additional applications for Depakote began to be introduced. Over the next several years Depakote began to be prescribed for migraine headaches and the chronic pain associated with nervous system diseases and neuropathies.

If Depakote is used during pregnancy, or if a woman becomes pregnant while taking Depakote, she and her doctor should be aware of the serious risk to the fetus of birth defects. The use of Depakote during pregnancy has potentially been shown to cause serious harm to the fetus, often resulting in severe and irreversible birth defects. The birth defects associated with taking Depakote during pregnancy most commonly include spina bifida, the most common form of neural tube defects; however, other serious congenital malformations have also occurred.

Neural tube defects occur when the embryonic neural tube fails to close completely. Serious defects like spina bifida and anencephaly are both results of neural tube defects.

According to a 2004 study presented at the annual meeting of the American Academy of Neurology, children born to women taking Depakote are much more likely to suffer birth defects and other problems. Researchers said that if possible women should avoid taking this medication during their childbearing years.

In the study, researchers showed these problems were more common when women took Depakote during pregnancy compared with women who took a newer drug, Lamictal. Serious birth defects and developmental delays occurred in 28% of children whose mothers took Depakote compared with just 2% of children whose mothers took the newer drug. 

Depakote Birth Defect Side Effects

Severe Depakote side effects may include:

• Spina bifida
• Spina bifida occulta
• Spina bifida closed neural tube defects
• Spina bifida meningocele
• Spina bifida myelomeningocele (cystica)
• Neural tube closure defects
• Coarctation of the aorta
• Atrial septal defects
• Pulmonary stenosis
• Hypoplastic right heart
• Dysplastic ribs
• Cleft palate
• Limb malformations
• Hydronephrosis (distention and dilation of the renal pelvis)
• Undescended testes
• Hypospadias (male birth defect involving a misplaced urethral opening)
• Skeletal defects
• Anencephaly
• Rachischisis
• Death of the newborn

Speak to a Depakote Spina Bifida Lawyer

If your child was born with spina bifida, neural tube defects or other severe birth defects that may have resulted from taking Depakote during pregnancy, please contact our law firm immediately to discuss your legal options. Speak to a Depakote Spina Bifida lawyer about your child’s skeletal defects, spina bifida, growth retardation or other injuries and learn about what legal options are available to your family. Our law firm has represented thousands of clients over the last twenty five years and thoroughly understands drug litigation. Contact an Depakote Spina Bifida Attorney today for a free and confidential Depakote Spina Bifida Lawsuit evaluation.