FOR IMMEDIATE RELEASE:

Tysabri PML Lawsuits – Willis Law Firm Representing Families of Two Tysabri PML Patients

Houston, Texas – December 20, 2010 – The Willis Law Firm, currently representing two of the fewer than seventy-five known cases of Tysabri induced PML worldwide, is accepting new Tysabri PML clients and lawsuits.

According to the FDA, Tysabri (also known as natalizumab), a drug prescribed in the treatment of Multiple Sclerosis (MS) and Crohn’s disease, has been linked to the increased risk of progressive multifocal leukoencephalopathy (PML).  PML is a very rare and opportunistic viral infection of the brain that usually leads to severe disability and/or death. Tysabri was pulled from the market over safety concerns in 2005 but returned a year later in 2006.

Current Willis Law Firm Tysabri PML clients include:

• 36 year old female multiple sclerosis patient who had been infused with Tysabri 24 times over a period of two years.  She was diagnosed with PML in 2009 and is now under 24 hour care and has lost the ability to communicate.  She was a member of the Tysabri “Touch Program” and is listed as only the 7^th Tysabri PML case in the world and only the 2^nd in the U.S. 
• Family of a deceased 40 year old multiple sclerosis patient and mother of two.  According to medical records, the patient’s MS symptoms were under control at the time she was prescribed Tysabri.  Following only her second Tysabri infusion, she experienced a sudden onset of PML-like symptoms, suffered a rapid decline in health, and eventually died within 30 days of the Tysabri infusion.  Our firm’s medical consultants believe this is suggestive of a possible Tysabri PML link.

In a letter dated March 25, 2010, the US FDA notified the Senior Vice President of Regulatory Affairs for Biogen Idec, Inc., the manufacturer of Tysabri, that Biogen’s promotion of Tysabri contained “false or misleading” information. The letter went on to state that Biogen’s promotional information regarding Tysabri “minimizes important risks associated with the use of Tysabri and omits the drug’s approved indication.”

Biogen has ceased sharing information with the public on their corporate website regarding any new PML cases.  This was announced after the 11^th documented PML patient, back in March of 2009.  Biogen currently states that “any new cases will be reported by word of mouth to medical professional and patient groups”.

Patients and/or family members of those treated with Tysabri infusions and then later diagnosed with PML are encouraged to contact The Willis Law Firm to speak to a Tysabri PML lawyer about their legal options regarding the possible filing of a Tysabri PML Lawsuit.  Please keep in mind that certain states have statutes of limitation which limit the amount of time a person may have to file a lawsuit or seek legal action. All cases are taken on a Contingency Fee Basis. No fees or expenses are charged to the client unless a recovery is made, or settlement obtained for the Tysabri PML patients and their families.

“The expertise that our firm has gained in the assistance of our current group of Tysabri PML clients and their families has given us the unique perspective required to help these victims and pursue this rare and complex type of case”, stated  David P. Willis, principal attorney at The Willis Law Firm.

The Willis Law Firm, a Nationally Recognized Drug Litigation Law Firm, is dedicated to fighting for the rights of those harmed by dangerous and recalled drugs and medical devices.  For 25+ years, Attorney David P. Willis, a Board Certified Personal Injury Trial Lawyer, has represented seriously injured clients and their families in product liability, personal injury, and defective drug litigation lawsuits involving pharmaceutical and medical device companies. Mr. Willis is licensed in Texas and New York and assists victims of defective products and dangerous drugs nationwide. For more information, call The Willis Law Firm toll free at: 1-800-883-9858 or visit www.Tysabri-PML.com

Contact:

David P. Willis
press@injuryoffices.com
1221 McKinney Street
Suite 3333
Houston, Texas 77010
USA

Ph: 800-883-9858
www.drug-attorneys.com

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Children born with cardiac and other congenital birth defects have possibly been linked to use of the anti-depressant drug bupropion (Aplenzin, Wellbutrin, Wellbutrin SR, Wellbutrin XL, Zyban) during pregnancy, based on findings published in the American Journal of Obstetrics & Gynecology. The study found that mothers of infants born with a specific type of congenital heart defect were more likely to have reported taking Wellbutrin (bupropion) than mothers of control infants. They identified a positive association between early pregnancy bupropion use and congenital heart defects.

Antidepressant Drugs Include:

What is Welbutrin (bupropion)?

Wellbutrin (bupropion) is an antidepressant of the aminoketone class. Bupropion is also marketed as Zyban for use as a smoking cessation aid. Most antidepressants available by prescription are of the SSRI class, so Wellbutrin may be effective if common SSRI antidepressants fail to combat major depression symptoms. Wellbutrin may, in some cases, also be taken concurrently with SSRI antidepressants.

In 1985, SmithKline Beecham (now Glaxo SmithKline) introduced bupropion hydrochloride under the brand name Wellbutrin. When Wellbutrin was first introduced onto the market, a high rate of seizures in users caused it to be recalled fairly quickly. In 1996, the FDA approved the drug in a sustained-release version called Wellbutrin SR and, in 2003, an extended-release version called Wellbutrin XL. Bupropion (Aplenzin, Wellbutrin, Wellbutrin SR, Wellbutrin XL, Zyban) has been prescribed to treat depression and in some cases has been prescribed to assist in smoking cessation treatment. Bupropion (Wellbutrin XL) is also prescribed to treat seasonal affective disorder (SAD; episodes of depression that occur in the fall and winter each year). Bupropion is in a class of medications called antidepressants, and works by increasing certain types of activity in the brain.

Wellbutrin Birth Defects

The most common heart defects found involving Wellbutrin (bupropion) were left outflow tract defects. Left outflow heart defects affect the flow of blood from the heart’s left chambers to the rest of the body. The most common type of left outflow tract heart defect was coarctation of the aorta (CoA) — a narrowing in the body’s main artery. In another recent study, researchers also found that among more than 12,700 U.S. infants born between 1997 and 2004, those whose mothers used Wellbutrin (bupropion) during early pregnancy had more than double the risk of these same heart defects. If you have a child suffering from congenital heart defects or other severe congenital malformations and you were prescribed Wellbutrin during pregnancy, you may have a cause of action against Glaxo SmithKline, the creator of Welbutrin.

For years, antidepressant drugs like Wellbutrin, Lexapro, Celexa, Prozac, Zoloft and Paxil have been linked to cases of serious congenital heart defects, 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), 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 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.

Wellbutrin Class Action Lawsuit vs. Wellbutrin Lawsuit

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

In Wellbutrin lawsuits involving catastrophic injury or death, an individual lawsuit, in most cases, is more appropriate and in the plaintiff’s best interest. Antidepressant drugs like Wellbutrin, Lexapro, Celexa, Paxil, Prozac 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), and coarctation of the aorta (CoA). Wellbutrin cases such as these are better suited to an individual Wellbutrin lawsuit because of the severity and degree of injury to the plaintiff. In an individual Wellbutrin Lawsuit, each plaintiff’s case is filed, presented and considered individually, based on its own strength and the degree of injury.

In many cases involving antidepressants like Wellbutrin, Lexapro, Celexa, Paxil, Prozac and Zoloft and the serious congenital heart defects related to these antidepressant drugs, 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 Wellbutrin lawsuit allows each Wellbutrin 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 a Wellbutrin Lawsuit Lawyer

If your child was born with a severe birth defect and you were prescribed Wellbutrin during pregnancy, please contact our law firm immediately to discuss your legal rights to file a Wellbutrin Lawsuit and for information regarding a Wellbutrin Class Action Lawsuit. Please keep in mind that certain states have filing deadlines or statutes of limitation that limit the amount of time you have to file a lawsuit or seek legal action. Speak to a Wellbutrin lawyer if your child has been born with Coarctation of the Aorta, other congenital heart defects, required open heart surgery, or required a heart transplant to correct a Wellbutrin related congenital birth defect.

Wellbutrin Birth Defect Lawsuit

Our law firm has assisted thousands of clients over the past twenty-seven years and thoroughly understands pharmaceutical product-liability and drug litigation. You are not alone. Contact us today for a free and completely confidential Wellbutrin Side Effects lawsuit evaluation. Talk to a Wellbutrin Lawyer now about your rights. Please fill out our online form or call our law firm toll free at (800) 883-9858.

Children born with a heart defect, lung defect or other congenital birth defects have possibly been linked to use of the antidepressant drug Zoloft. Research suggests serious Zoloft side effects, including the increased risk of congenital heart defects and lung defects. This link between Zoloft and congenital heart defects and congenital lung defects has many concerned that pregnant women should not be prescribed Zoloft while pregnant. SSRIs like Zoloft have been linked to increased risk of Persistent Pulmonary Hypertension of the Newborn (PPHN).

Antidepressant Drugs Include:

What is Zoloft?

Zoloft (Generic: Sertraline) is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Zoloft affects chemicals in the brain that may become unbalanced and cause symptoms. Zoloft is used to treat depression, obsessive-compulsive disorder (OCD), panic disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD). The FDA approved Zoloft, manufactured by Pfizer, for depression in 1992, for OCD in 1996, for PMDD in 2002, and for SAD in 2003.

Zoloft Heart Defects

SSRI antidepressants like Zoloft, Prozac, Paxil and Celexa have been linked to cases of serious congenital heart defects, which may include atrial septal defects (ASD), ventricular septal defects (VSD) a heart defect, tetrology of fallot (ToF) a heart defect, hypoplastic left heart syndrome (HLHS) a heart defect, transposition of the great arteries (TGA or TOGA) a heart defect, patent ductus arteriosus (PDA) a heart defect, total anomalous pulmonary venous return (TAPVR) a heart defect, double outlet right ventricle (DORV) a heart defect, and coarctation of the aorta (CoA) a heart defect. In many heart defect cases, surgery is required when the child is very young (first three years of life) and then again, potentially multiple times, as the child grows to adulthood. Most congenital heart defect cases are treatable when they are diagnosed and addressed early on. Children with a heart defect may then be able to lead a mostly normal and productive life following medical attention. In some cases with a heart defect, the only viable option to correct these severe heart defects and preserve the child’s life involves a heart transplant.

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

It is also known is that there is a strong link between other SSRI antidepressants other than Zoloft and other congenital malformations, including lung, cranio-facial and abdominal wall malformations. A study conducted at Aarhus University Hospital, Denmark, revealed that the risk of pregnant women giving birth to babies with congenital defects, including heart defects and other defects, was increased among women who had prescriptions for SSRIs filled in the 30 days before conception through the end of the first trimester, compared with those who had no SSRI prescriptions filled during the same period.

The FDA has categorized Zoloft as a “Category C” drug, in terms of pregnancy risk, which means that animal studies may indicate fetal harm from maternal use of the drug. Human trials have not yet been conducted that determine that the risks of using Zoloft during pregnancy outweigh the drug’s intended benefits.

Women who are taking SSRI antidepressants, including Zoloft, and are pregnant or thinking about becoming pregnant should speak with their doctor about the risks of a heart defect associated with taking Zoloft or any other SSRI antidepressant while pregnant. There are risks associated with taking Zoloft while pregnant, and there may also be concerns about abruptly discontinuing Zoloft or other SSRI medications. All risks of a heart defect should be discussed with a physician and balanced against the possible benefits of taking Zoloft.

Congenital Heart Defects from Antidepressant SSRI Drugs:

• Hypoplastic Left Heart Syndrome (HLHS)
• Pulmonary Atresia
• Tricuspic Atresia
• Transposition of the Great Vessels
• Transposition of the Great Arteries
• Atrial Septal Defect (hole in the heart)
• Ventricular Septal Defect (hole in the heart)
• Coarctation of the Aorta
• Tetralogy of Fallot
• Double Outlet Right Ventricle
• Truncus Arteriosus
• Double Inlet Left Ventricle
• Double Aortic Arch
• Pulmonary Valve Stenosis
• Patent Ductus Arteriosus
• Tetralogy of Fallot

SSRI Antidepressant Congenital Birth Defects:

• Persistent Pulmonary Hypertension of the Newborn (PPHN)
• Omphalcele – Abdominal Wall Malformation
• Gastrochesis – Abdominal Wall Malformation
• Craniosynostosis – Cranio-facial Malformation
• Clubfoot – Limb Malformation
• Hypospadias

Zoloft Class Action Heart Defect Lawsuit vs. Individual Lawsuit

There are distinct differences between a Zoloft (sertraline) class action heart defect lawsuit and a more typical individual Zoloft heart defect lawsuit. A Zoloft class action heart defect lawsuit would be a form of Zoloft lawsuit in which a large group of people (Zoloft plaintiffs) collectively bring a Zoloft heart defect lawsuit to court in the form of a “class action” against the manufacturers of Zoloft (defendant). In a Zoloft class action heart defect lawsuit involving personal injury, resulting from defective products such as antidepressant SSRI drugs like Zoloft (sertraline), Paxil (paroxetine), Prozac (fluoxetine) and Celexa (citalopram), all Zoloft lawsuit plaintiffs would typically be grouped together into a single Zoloft class action lawsuit, regardless of the degree or severity of their Zoloft birth defect injuries. In this type of Zoloft class action lawsuit, Zoloft plaintiffs with injuries ranging from minor heart murmurs not requiring surgery, all the way to the most severe congenital Zoloft heart defects, requiring multiple surgeries or even a complete heart transplant, would be grouped into one single Zoloft class action lawsuit. All Zoloft 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, an individual Zoloft lawsuit, in most cases, is more appropriate and in the Zoloft plaintiff’s best interest. SSRI antidepressants like Zoloft, Prozac, Celexa and Paxil (paroxetine), 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 Zoloft plaintiff. In an individual Zoloft Lawsuit, each Zoloft 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, Paxil and the serious congenital heart defects related to these SSRI antidepressants, heart defect 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 born with a heart defect may be able to lead mostly normal and productive lives. An individual Zoloft heart defect lawsuit allows each Zoloft victim, their heart defect 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 Zoloft class action lawsuit.

See also: Zoloft Heart Defect Lawsuit

Zoloft Autism

A recent study published by Archives of General Psychiatry has found a link between antidepressant use during pregnancy and Autism Spectrum Disorder (ASD). Pregnant women taking Zoloft antidepressants during the first trimester of pregnancy may triple the chances of their child having Zoloft autism. This study was prompted when researchers noticed a rise over the past few years in the use of selective serotonin reuptake inhibitor antidepressant (SSRIs) and an increase in Zoloft autism diagnoses.

Zoloft Autism Side Effects

• Autism from Zoloft
• ASD – Autism Spectrum Disorder
• PDD – Pervasive Developmental Disorder
• PDD – NOS – Pervasive Developmental Disorder – Not Otherwise Specified

If you or a loved one took Zoloft while pregnant and have a child that may suffer Zoloft autism or other Zoloft birth defects, contact our law firm immediately to discuss the legal options available to you and your family.

See also: Autism Lawsuit: Antidepressants During Pregnancy Increase Autism Risk

Speak to a Zoloft Lawyer

If you took Zoloft or generic sertraline during pregnancy and your child was born with a heart birth defect or a lung birth defect, we encourage you to contact a Zoloft heart defect litigation attorney at our law firm immediately. It may be too late to recover from the devastating effects of Zoloft heart defects, but an experienced products liability Zoloft attorney at the Willis Law Firm can assist you in legal action against the makers of Zoloft. You are not alone. Join other Zoloft heart defect, Zoloft lung defect, and other Zoloft birth defect victims and their families in speaking up and fighting for your legal rights.

Zoloft Birth Defect 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 a Zoloft heart defect lawyer at our law firm immediately so we may explain the rights and options available to you and your family.

Defective Product Alert: Severe Frostbite and Nerve Damage From Use of Cold Therapy Machines

As of late, reports have been circulating about the potential for permanent nerve damage and skin damage resulting from the use of cold therapy – cryotherapy devices such as PolarCare, EBIce,  Don Joy. These products are defective and the public should generally be aware of the dangers associated with them. If cold therapy devices are used too long, or at too cold of a temperature, it can result in serious injuries such as nerve damage, chronic pain, or frost bite. With few or no instructions or warnings, patients may be subjecting skin and underlying nerves to unacceptably cold temperatures for extended periods of time. Since cold &  ice therapy can desensitize the affected area, serious injuries often occur without the patient’s immediate knowledge. Case studies have documented this injury pattern. 

Cold therapy machines and cryotherapy devices prescribed by doctors are essentially small ice coolers which a patient fills with ice and water, and uses with an attached conforming device to chill a certain area of the body. A small motor inside the cooler circulates the chilled water through the plastic bladder that is placed on a patient’s affected area. The circulated ice water super chills the targeted area of the body, usually the feet, knees, ankles and shoulders.  While it may dull the pain, it also may numb the area to a point where the patient is unaware of the resulting frostbite and permanent nerve damage.  It can have disastrous consequences due to the defective nature of the product and lack of warnings and instructions.

Why Cold Therapy Ice Machines are Defective

Many cold therapy machines are defective in design. Their super cooling capabilities can cause serious crynotherapy frostbite injuries to both the skin and permanent nerve damage to the nerves of the area where the product is applied. The cold therapy machines are defective because there is no regulation of the temperature or how cold the device will make the patient’s skin. There are also very few instructions or warnings provided with the Cold Therapy units dictating how long a patient can super chill a certain area of the body without risking a frostbite type injury. These devices are particularly dangerous, since once an area of a patient’s body is super-chilled, it becomes numb and the patient is unable to feel the frostbite injury occurring, often leading to even greater injury.

Known Cold Therapy Ice Machine Injuries

Often, a patient will awaken from surgery or other forms of treatment, only to find that a Cold Therapy Unit had been applied to them immediately after surgery without their knowledge or understanding.  In many of these cases, the Cold Therapy machine had been in place on the patient’s body for several hours even before they awaken, at far too low a temperature setting, thus possibly having already caused serious frostbite and permanent nerve damage injuries. The types of injury resulting from these cryotherapy or cold therapy machines and devices are primarily frostbite. This type of injury is characterized by decreased blood flow and heat delivery to body tissues resulting in disastrous ice crystal formation within the cells of the skin. These skin injuries can be classified as deep or superficial depending on the depth of injury and length of the crynotherapy cold exposure. They can involve the skin, while more serious injuries extend into the muscle and involve the nerves and even bone. These injuries can cause permanent nerve damage and chronic debilitating pain. Case studies have documented this injury pattern.

Cold Therapy Attorney

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

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.

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 at the right or call us toll-free at 1-800-883-9858.

What is Reflex Sympathetic Dystrophy (RSD)?

RSD is a chronic nervous system condition characterized by severe burning pain, pathological changes in bone and skin, excessive sweating, tissue swelling, and extreme sensitivity to touch. The syndrome is a nerve disorder that occurs at the site of an injury (most often to the arms or legs). It occurs especially after injuries from high-velocity impacts such as those from bullets or shrapnel. However, it may occur without apparent injury, as in the case of exposure to extremely low temperatures for extended periods of time.  Recently the US FDA has linked the use of certain types of Cold Therapy Ice Machines with these types of injuries and syndromes. 

The condition called “causalgia” was first documented in the 19th century by physicians concerned about pain that Civil War veterans continued to experience after their wounds had healed. Doctors often called it “hot pain,” after its primary symptom. Over the years, the syndrome was classified as one of the peripheral neuropathies, and later, as a chronic pain syndrome. Currently, there are two types that are differentiated-type I and type II. Both types share the same basic set of symptoms, but have one distinct difference: type I (previously referred to as RSD) describes cases in which there is no nerve injury, while type II (formerly called causalgia) refers to cases in which a distinct nerve injury, for example from a gunshot wound, has occurred

What are the Symptoms of Reflex Sympathetic Dystrophy (RSD)?

The symptoms of RSD usually occur near the site of an injury, either major or minor, and include: burning pain, muscle spasms, local swelling, increased sweating, softening of bones, joint tenderness or stiffness, restricted or painful movement, and changes in the nails and skin. One visible sign of RSD near the site of injury is warm, shiny red skin that later becomes cool and bluish.

The pain that patients report is out of proportion to the severity of the injury and gets worse, rather than better, over time. It is frequently characterized as a burning, aching, searing pain, which may initially be localized to the site of injury or the area covered by an injured nerve but spreads over time, often involving an entire limb. It can sometimes even involve the opposite extremity. Pain is continuous and may be heightened by emotional stress. Moving or touching the limb is often intolerable. Eventually the joints become stiff from disuse, and the skin, muscles, and bone atrophy.

The symptoms of RSD vary in severity and duration. However, there are usually three stages associated with RSD, and each stage is marked by progressive changes in the skin, nails, muscles, joints, ligaments, and bones. Stage one lasts from 1 to 3 months and is characterized by severe, burning pain at the site of the injury. Muscle spasm, joint stiffness, restricted mobility, rapid hair and nail growth, and vasospasm (a constriction of the blood vessels) that affects color and temperature of the skin can also occur.

In stage two, which lasts from 3 to 6 months, the pain intensifies. Swelling spreads, hair growth diminishes, nails become cracked, brittle, grooved, and spotty, osteoporosis becomes severe and diffuse, joints thicken, and muscles atrophy.

As the patient reaches stage three, changes in the skin and bones become irreversible, and pain becomes unyielding and may now involve the entire limb. There is marked muscle atrophy, severely limited mobility of the affected area, and flexor tendon contractions (contractions of the muscles and tendons that flex the joints). Occasionally the limb is displaced from its normal position, and marked bone softening is more dispersed.

What Causes Reflex Sympathetic Dystrophy (RSD)?

RSD was originally thought to be the result of malfunctioning nerves of the sympathetic nervous system-the part of the nervous system responsible, for example, for controlling the diameter of blood vessels. This idea has been called into question and the mechanism remains controversial.

Since RSD is most often caused by trauma to the extremities, other conditions that can bring about RSD include sprains, fractures, surgery, damage to blood vessels or nerves, and cerebral lesions. The disorder is unique in that it simultaneously affects the nerves, skin, muscles, blood vessels, and bones.  Recently Cold Therapy Ice Machines have been linked to RSD resulting from cryotherapy.  The FDA has issued a warning related to the improper use of Cold Therapy Ice Machines made by manufacturers such as DonJoy, PolarCare, & EBIce.  These crynotherapy units, when used for prolonged periods or at temperature settings too low, have been linked to permanent nerve damage such as RSD and CPND.

Who Gets Reflex Sympathetic Dystrophy (RSD)?

RSD can strike at any age, but has usually been more common between the ages of 40 and 60. Recent reports show that the number of RSD cases among adolescents and young adults is increasing. It affects both men and women, but is most frequently seen in women.

Investigators estimate that two to five percent of those with peripheral nerve injury and 12 to 21 percent of those with hemiplegia (paralysis of one side of the body) will suffer from RSD.

How is Reflex Sympathetic Dystrophy (RSD) diagnosed?

RSD is often misdiagnosed because it remains poorly understood. Diagnosis is complicated by the fact that some patients improve without treatment. A delay in diagnosis and/or treatment for this syndrome can result in severe physical and psychological problems. Early recognition and prompt treatment provide the greatest opportunity for recovery.

RSD is diagnosed primarily through observation of the symptoms. However, some physicians use thermography (a diagnostic technique for measuring blood flow by determining the variations in heat emitted from the body) to detect changes in body temperature that are common in RSD. A color-coded thermogram of a person in pain often shows an altered blood supply to the painful area, appearing as a different shade (abnormally pale or violet) than the surrounding areas of the corresponding part on the other side of the body. An abnormal thermogram in a patient who complains of pain may lead to a diagnosis of RSD. X-rays may also show changes in the bone.

What is the Prognosis Associated with Reflex Sympathetic Dystrophy (RSD)?

Good progress can be made in treating RSD if treatment is begun early, ideally within 3 months of the first symptoms. Early treatment often results in remission. If treatment is delayed, however, the disorder can quickly spread to the entire limb and changes in bone and muscle may become irreversible. In 50 percent of RSD cases, pain persists longer than 6 months and sometimes for years.

What is the Treatment for Reflex Sympathetic Dystrophy (RSD)?

Physical therapy is the mainstay of therapy. Physicians use a variety of drugs to treat RSD, including corticosteroids, vasodilators, and alpha- or beta-adrenergic-blocking compounds. Elevation of the extremity may be helpful. Injection of a local anesthetic, such as lidocaine, is sometimes used. Injections are repeated as needed. TENS (transcutaneous electrical stimulation), a procedure in which brief pulses of electricity are applied to nerve endings under the skin, has helped some patients in relieving chronic pain.

In some cases, surgical or chemical sympathectomy-interruption of the affected portion of the sympathetic nervous system-has been used to relieve pain. Surgical sympathectomy involves cutting the nerve or nerves, destroying the pain almost instantly. But surgery is controversial and may also destroy other sensations.

 Other Disorders Similar to Reflex Sympathetic Dystrophy (RSD)

RSD has characteristics similar to those of other disorders, such as shoulder-hand syndrome, which sometimes occurs after a heart attack and is marked by pain and stiffness in the arm and shoulder; Sudeck’s syndrome, which is prevalent in older people and in women and is characterized by bone changes and muscular atrophy, but is not always associated with trauma; and Steinbrocker’s syndrome, which affects both sexes but is slightly more prevalent in women, and includes such symptoms as gradual stiffness, discomfort, and weakness in the shoulder and hand.

Cold Therapy Attorney

Poorly designed cold therapy machines can cause permanent nerve damage, frostbite, and numerious other serious side effect injuries. Seek immediate medical attention if you are suffering an emergency situation.

Cold therapy lawsuits are currently being filed by attorneys 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.

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

PML is a rare disorder that damages the material that covers and protects the nerves in the white matter of the brain. It is caused by the reactivation of the JC virus in the body and it infects the brain. JC virus is commonly acquired in childhood, but most people do not develop PML. The virus usually remains inactive and hardly ever causes symptoms-unless you have a significantly weakened immune system. People who have received Tysabri infusions, have AIDS, leukemia or lymphoma typically have a compromised immune system.

PML and Tysabri

Tysabri (Natalizumab) is a drug manufactured by Biogen Idec Inc. and Elan Corp. It is used to treat the symptoms of Multiple Sclerosis (MS) and Crohn’s disease, a gastrointestinal disorder. It is normally used after other treatments have not worked; it is not a cure, but a treatment. Tysabri is an immunosuppressant infusion that is used to help control the symptoms of relapsing MS (when the symptoms get worse then improve, and get worse again.) The use of Tysabri has been linked to PML (Progressive multifocal leukoencephalopathy), a rare but life threatening brain infection. The longer Tysabri is used, the more likely the risk of contracting PML.

Symptoms of PML

There is no “usual” course of PML, the area of the brain that is affected will determine how PML symptoms will appear. The symptoms can be similar to those of MS, and worsen rapidly. Some of the symptoms may include the following:

• Headaches
• Loss of balance and coordination
• Slurred speech, or loss of speech (aphasia)
• Memory Loss, confusion, disoriented
• Vision Problems that cause blurred vision or loss of vision
• Weakness or paralysis of one side of the body
• Tiredness
• Seizures

PML Diagnosis

The most accurate way to diagnose PML is by a brain biopsy. But, most brain specialists can diagnose PML by the patient’s clinical symptoms along with a MRI scan, and testing the Cerebrospinal fluid (CSF) for the JC virus. If PML is suspected the Tysabri should be stopped immediately and a clinical evaluation should be performed.

PML Treatment

There is no known cure for PML that is caused by Tysabri. In some cases, the disease may slow or stop once the medication is discontinued, but only if the patient’s immune system improves. The experimental drug treatments used for PML caused by Tysabri have not been very effective. PML is usually fatal and those who do survive the disease are often permanently disabled. Tysabri is intended to help those who suffer from MS or Crohn’s disease that other treatments have been unable to help, but in fact it may actually be fatal instead.

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. Every attorney at 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 with an Attorney.

Darvon, Darvocet Withdrawn in U.S. Over Heart Risks

November 19, 2010, 6:06 PM EST 

By Molly Peterson

(Updates with comment from consumer advocate in the 13th paragraph.)

Nov. 19 (Bloomberg) — Darvon, a 53-year-old pain pill, will be pulled from the U.S. market after a study found potentially fatal heart risks in healthy people who take the medicine at the recommended dose.

Xanodyne Pharmaceuticals Inc., the drug’s owner since 2005, will withdraw Darvon and Darvocet, a product that combines Darvon’s active ingredient with acetaminophen, Food and Drug Administration officials said today in a statement. The agency requested the move after evaluating study data, and asked makers of generic versions to take them off the market as well. Darvon’s active ingredient, the opioid propoxyphene, had been approved in 1957 for treating mild to moderate pain.

The U.K. announced in 2005 that it would pull propoxyphene- containing drugs from the market, citing reports of as many of 400 fatal overdoses a year. The European Medicines Agency recommended a ban last year. Also last year, the FDA rejected an advisory panel’s recommendation to withdraw the drug, opting instead to require a new safety study and a black-box warning label about the risks of excessive use.

Xanodyne’s new clinical research, combined with new epidemiological data, led the FDA to conclude that propoxyphene’s benefits no longer outweigh its risks, said John Jenkins, director of the agency’s Office of New Drugs.

All Users at Risk

The data “suggested that the heart risk of propoxyphene could apply to all users, not just those who took excessive doses or those with medical conditions,” such as reduced kidney function, Jenkins said today during a conference call.

Xanodyne, a closely held drugmaker in Newport, Kentucky, that doesn’t disclose sales figures, acquired Darvon and Darvocet in July 2005 from a company that had bought the rights from Indianapolis-based Eli Lilly & Co., the developer of the medicines.

Xanodyne removed the drug as “part of a market-wide withdrawal applying to all propoxyphene-containing products, affecting branded and generic pharmaceutical companies,” the company said today in a statement. Darvon and Darvocet represent less than 1 percent of the propoxyphene market in total prescriptions, Natasha Giordano, Xanodyne’s chief executive officer, said today in a separate e-mail.

Those two brands “have never been promoted in any way by Xanodyne, neither through personal promotion by sales representatives nor direct-to-consumer or direct-to-doctor advertising or promotions,” Giordano said.

U.S. Prescriptions

About 10 million people in the U.S. received prescriptions for propoxyphene-containing products in 2009, said Gerald Dal Pan, director of the FDA’s Office of Surveillance and Epidemiology, on the conference call.

“For the first time, we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart,” he said in the statement.

Users of the drug “need to know that these changes to the heart’s electrical activity are not cumulative,” he said. “Once patients stop taking propoxyphene, the risk will go away.”

Public Citizen will ask Congress to investigate why the FDA didn’t take propoxyphene off the market years ago, said Sidney Wolfe, the Washington-based consumer group’s director of health research.

Wolfe’s group petitioned the FDA in 1978 and in 2006 to ban the drug.

–With assistance from Catherine Larkin in Washington. Editors: Steve Walsh, Andrew Pollack

To contact the reporter on this story: Molly Peterson in Washington at mpeterson9@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.

The widely prescribed painkillers are linked to serious heart rhythm abnormalities in a new study. Experts say patients and doctors should have little difficulty finding alternatives.

By Andrew Zajac, Tribune Washington Bureau – Los Angeles Times

November 20, 2010

The maker of Darvon and Darvocet announced Friday that it would stop marketing the widely used painkillers in the U.S. because a new study links the active ingredient to serious and sometimes fatal heart rhythm abnormalities.

The FDA requested the withdrawal and urged doctors to stop prescribing the drugs immediately. But it advised patients to keep taking their medication while consulting quickly with physicians to find an alternative. Pain management experts said the drugs are easily replaceable.

The decision follows years of controversy about Darvon’s dangerous side effects.

Sidney Wolfe of Public Citizen’s Health Research Group blasted the FDA’s action as too late and called for congressional hearings into why the agency took so long. Public Citizen tried for more than three decades to limit use of the drug and petitioned the FDA to ban it in 2006.

Known generically as propoxyphene, Darvon is an opioid used to treat mild to moderate pain. Made by Xanodyne Pharmaceuticals Inc. of Newport, Ky., the drug was approved by regulators in 1957. Less than 1% of prescriptions are for the brand name, the company said. The FDA also asked generic manufacturers to stop making it for the U.S. market.

The FDA estimated that propoxyphene was used by 10 million people in 2009, with most of them receiving it in combination with acetaminophen, a compound known by the trade name Darvocet.

Many doctors who prescribe propoxyphene do so simply because it’s been around so long and they’re familiar with it, said Al Anderson, a Minneapolis family practitioner and president of the American Academy of Pain Management board of directors.

Anderson said the withdrawal would hurt a few patients who can’t tolerate other painkillers, but most patients have many alternatives, such as oxycodone, morphine and Nucynta.

“It certainly takes one tool away, but it’s a small tool,” Anderson said.

“We have many better options,” said Mehul Desai, director of pain medicine at George Washington University Hospital in Washington. “It tends to be a pretty poor pain reliever.”

Propoxyphene was effectively pulled from the British and European Union markets earlier because of regulators’ health concerns: Britain in 2005 and the EU in June 2009.

In January 2009, an FDA advisory committee voted 14-12 against continued marketing of propoxyphene. The FDA rejected that recommendation but required a study of the drug’s cardiac effects.

That study showed an increased risk for heart arrhythmias even in healthy patients, not just those weakened by illness.

“We concluded that the pain-relief benefit no longer outweighed the health risks,” said John Jenkins, director of new drugs in the FDA’s Center for Drug Evaluation and Research, in a telephone news conference with reporters.

Wolfe said the FDA should have acted much sooner. Data about heart toxicity was available from an animal study 30 years ago, he said, and at least 1,000 people in the U.S. have died from using propoxyphene since Britain’s 2005 ban.

He labeled the agency’s inaction “a serious indictment of the FDA’s long-lasting unwillingness to protect people in this country from a deadly but barely effective painkiller.”

But judged against its regulatory behavior in recent years, Friday’s announcement continues a harder line on drug safety. It’s the second time in six weeks the FDA has pushed to have a drug removed from the market.

azajac@latimes.com

Copyright © 2010, Los Angeles Times

Darvon, Darvocet Banned

Controversial Painkiller Sunk by Dangerous Heart Side Effects

Nov. 19, 2010 — The FDA has at last banned Darvon, Darvocet, and other brand/generic drugs containing propoxyphene — a safety-plagued painkiller from the 1950s.

New proof of heart side effects, in studies of healthy people taking normal doses of the drug, prompted the FDA to act.

An estimated 10 million Americans are taking Darvocet and other propoxyphene painkillers. They should NOT immediately stop taking the drugs, as there is danger of serious withdrawal symptoms.

Patients taking the drugs should instead immediately contact their doctors for help switching to different methods of pain control.

“Don’t delay,” warns Gerald Dal Pan, MD, MHS, director of the FDA’s office of surveillance and epidemiology.

The FDA action comes nearly six years after the drug was banned in the U.K., and nearly a year and a half after the European drug agency banned it.

The public interest group Public Citizen petitioned the FDA to ban the drug in 1978 and again in 2006. The latter petition caused the FDA to take the matter to an expert advisory committee, which in July 2009 voted 14-12 to ban the drug.

But the FDA overruled the panel, instead asking Darvon/Darvocet maker Xanodyne Pharmaceuticals Inc. to conduct studies of the drug’s effects on the heart. The results of those studies led to the FDA ban.

“The drug puts patients at risk of abnormal or even fatal heart rhythm abnormalities,” John Jenkins, MD, director of the FDA’s office of new drugs at the Center for Drug Evaluation and Research, said at a news conference. “Combined with prior safety data, this altered our risk assessment.”

The FDA ban comes too late for Public Citizen, which blasted the FDA for waiting far too long to protect the public.

“Due to FDA negligence, at least 1,000 to 2,000 or more people in the U.S. have died from using propoxyphene since the time the U.K. ban was announced,” Sidney Wolfe, director of Public Citizen’s health research group, says in a news release.

Wolfe says Public Citizen will call for a congressional investigation into who at the FDA “was responsible for the loss of so many lives in this country.”

Jenkins says although it’s impossible to know exactly how many deaths are linked to propoxyphene, an FDA study shows that more deaths are linked to the drug than to either of two alternative opioid painkillers, tramadol and hydrocodone.

Dal Pan says that people who have taken Darvocet, Darvon, or other propoxyphene drugs for a long time are not at increased risk of heart problems.

“Long-term users should not worry: The heart effects are not cumulative,” he says. “Once people stop using propoxyphene, the side effects should go away.”

More information about the propoxyphene ban is available on the FDA web site — including, for the first time, a video news release.