FDA Warning Points Towards Possible Avandia Lawsuit

Posted on March 17, 2008

The Food and Drug Administration (FDA) is continuing to review safety data on the drug rosiglitazone maleate. Some of these data suggest that rosiglitazone may increase a patient's risk of heart attack and heart-related deaths compared with other drugs that also treat type 2 diabetes. Rosiglitazone is sold as Avandia, Avandamet and Avandaryl.

A pooled analysis of 42 clinical studies provided by the manufacturer suggested that patients receiving short-term treatment with rosiglitazone may have a 30-40 percent greater risk of heart attack and other cardiovascular events compared with placebo or other anti-diabetic therapy. However, other published and unpublished data from long-term clinical trials provide contradictory evidence about the risk.

It is uncertain at this point whether taking rosiglitazone does increase the risk of these adverse events and if so, by how much. It is also not clear whether pioglitazone, the other approved product in the same drug class, may pose the same risk. Also, switching diabetic patients from one drug to another carries its own inherent risk. Healthcare professionals should consider these factors when deciding about treatment for their diabetic patients. FDA's review of all the available data is continuing.

Update on Avoiding Gadolinium - Containing Contrast Agents in Patients with Renal Failure

Posted on April 1, 2006

Gadolinium is a rare earth metal with unusual paramagnetic properties that make it useful for magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA), as a contrast agent to enhance images and to evaluate blood vessels. However, the FDA has not approved Gadolinium for use in MRA.

In June of 2006, the FDA issued a public health advisory to alert doctors about the possible link between Gadolinium-based contrast agents and Nephrogenic Systemic Fibrosis (NSF). At that time, there were 25 known cases of NSF in patients with kidney failure. Then on May 23, 2007, the FDA send out an updated statement regarding gadolinium asking the manufacturer to include a black box warning on the product about the risk of developing NSF.

Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NFD), is a skin condition that is often described as a swelling and tightening of the skin, usually in the extremities, resulting in decreased mobility of joints. The condition may develop over a short period of days or could take weeks to fully develop. Symptoms of NSF include swelling, hardening and tightening of the skin, joint stiffness, or darkened patches on the skin. Over time, NSF becomes worse and can cause death, and unfortunately, there is no known treatment for NSF.

If you or a loved one has been diagnosed with nephrogenic systemic fibrosis, or if you are experiencing the symptoms associated with the disease from gadolinium used in a MRI or MRA, you may have a claim against the manufacturers of these gadolinium-based contrast agents. Please contact us today so we can help you get in touch with experienced Gadolinium attorneys to help you with your claim.

FDA Previous Update on Gadolinium - April 2006

FDA has received reports of 65 more cases of a rare, possibly fatal disease in patients with renal failure who receive a contrast agent containing gadolinium while undergoing certain imaging procedures. The disease, called Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD), is characterized by fibrosis of the skin and internal organs.

These new reports are in addition to cases that were reported on in mid-2006. In the new reports, the affected patients had end-stage kidney failure, and had either Magnetic Resonance Angiography (MRA) or Magnetic Resonance Imaging (MRI) with a gadolinium-based contrast agent. Their NSF/NFD began from 2 days to 18 months after exposure to the contrast agent. Although many of these patients received large amounts of the contrast agent, some received only one dose. In addition, researchers have found gadolinium deposits in the skin of patients who developed NSF/NFD.

There are currently five FDA-approved gadolinium-based contrast agents. Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance. These agents are approved for use during an MRI scan, but not for MRA.

Although NSF/NFD has been reported for only 3 of these 5 agents, FDA believes that there is a potential for NSF/NFD to occur with the use of any of the approved gadolinium-based agents.

Because of this, FDA is recommending that whenever possible, health care professionals choose imaging methods other than MRI or MRA with gadolinium for patients with moderate to end-stage kidney disease. If these patients must receive a gadolinium-based agent, consider prompt dialysis following the MRI or MRA.

Patients should be aware of the signs and symptoms of NSF/NFD and report these to their doctor. They include swelling and tightening of the skin, red or dark skin patches and difficulty flexing or extending the joints.

Finally, FDA is asking health care professionals and patients to report possible cases of NSF/NFD through FDA's MedWatch program.

Lawyers Contemplating Trasylol Lawsuit

January 2008 update

The heart surgery drug Trasylol (aprontinin) has been linked to a heightened risk of kidney failure and death. Trasylol is commonly used in patients undergoing heart surgery for blocked coronary arteries and other more complicated cardiovascular complications to control bleeding and induce clotting. An independent study released in January of 2006 suggests that the severity of Trasylol kidney failure risk may be as high as twice the risk of alternative medications, in addition to posing other serious side effects such as heart attack, stroke, and heart failure.

Bayer AG released Trasylol in 1993 following approval from the Food and Drug Administration. Reports of consistent adverse side effects have led researchers to believe that pretrial testing for the drug was insufficient. Dr. Dennis T. Mangano, who facilitated the research on Trasylol kidney failure, studied a sampling of heart surgery patients that was comprised of people taking Trasylol, people taking alternative medications, and those taking no medication at all for controlling blood loss.

People using Trasylol showed a 50 percent increased risk of heart attack, a 109 percent increase in risk of heart failure, and an alarming 181 percent increased risk of experiencing a stroke. Patients taking alternative medications comparatively experienced no signs of increased risk for kidney failure or any of the other adverse side effects.

Many doctors and surgeons involved with cardiovascular healthcare have expressed concern regarding Trasylol kidney failure since the initial release of the drug. However, results of the independent study are only now expected to impact sales and availability of Trasylol. Bayer has responded to the newly reported findings with skepticism, alleging that substantial testing was conducted prior to and during the drugs availability and produced results inconsistent with Dr. Mangano?s findings. Dr. Mangano has commented that he could not in good conscious give Trasylol to any patient knowing that there are safe and effective alternative medications. ?The least that should be done is to inform the patient that the risk of going on dialysis is increased 2 to 3 fold and there are alternatives,? the doctor added.

If you or a loved one has experienced Trasylol kidney failure, due to taking the medication, you may be entitled to compensation for your losses and suffering. Contact us to get in touch with a Trasylol attorney who can help you understand your legal rights and maximize your claims.

Bayer Suspends Marketing of Trasylol Suspended

Bayer Pharmaceuticals has suspended the marketing of Trasylol (aprotinin) which is used to reduce perioperative blood loss during cardiac surgery with cardiopulmonary bypass. Preliminary results of a Canadian study indicate that while patients given Trasylol experience fewer serious bleeding events, they may also have a greater risk of death than patients taking either of two other antifibrinolytic drugs.

Sales of Trasylol will be suspended until FDA can conduct a thorough analysis of the study and gain a better understanding of the risks and benefits of the drug. Because there are few treatment options for patients at risk for excessive bleeding during cardiac surgery, FDA is working with Bayer to gradually phase Trasylol out of the marketplace so that it doesn't cause shortages of other drugs used for this purpose.

FDA is also exploring ways that physicians may continue to have access to Trasylol in specific cases where the benefits of the drug outweigh the risks.

Personal Injury - Do You Need A Personal Injury Lawyer?

Posted on April 9, 2008

Does this video constitute personal injury? Lawsuit.com will have to leave that to the jury, but we can say the following:

Personal injury is any harm caused to a person, such as a broken bone, a cut, or a bruise that has resulted from an attack, negligence, or accident. In personal injury cases, a lawyer can file a lawsuit to recover damages from whoever is responsible for your injuries. On average, 11,200 disabling accidental injuries take place every hour each year.

Personal injuries can also be any injury resulting from libel, slander, malicious prosecution, or false arrest, any bodily injury, sickness, disease, or death sustained by any person and caused by an occurrence for which the state or anyone else may be held liable. Common personal injury claims are: Defective Products, Automobile Accidents, Bus Accidents, Dog Bites, Wrongful Death, Slip and Fall, Workplace Injuries, Catastrophic Injuries, Aviation Accidents, Trucking Accidents, Motorcycle Accidents, Boat Accidents, and Brain Injury,

If you or a loved one have been injured due to the someone else's negligence then please contact us today. We can help you get in touch with experienced legal professionals who can help you with your claim.

A Hard Look At the Devastation Mesothelioma Can Cause

Posted on April 1, 2008

This video is obviously based on studies done in the United Kingdom. However, make no mistake about it- mesothelioma IS a killer in the United States as well. Lawsuit.com elaborates:

Mesothelioma is a rare form of cancer in which malignant (cancerous) cells are found in the mesothelium, a protective sac that covers most of the body?s internal organs. Most people who develop mesothelioma have worked on jobs where they inhaled asbestos particles. Mesothelioma is a disease in which cells of the mesothelium become abnormal and divide without control or order. They can invade and damage nearby tissues and organs. Cancer cells can also (spread) from their original site to other parts of the body. Most cases of mesothelioma begin in the pleura or peritoneum.

Working with asbestos is the major risk factor for mesothelioma. A history of asbestos exposure at work is reported in about 70 percent to 80 percent of all cases. However, mesothelioma has been reported in some individuals without any known exposure to asbestos.

Asbestos is the name of a group of minerals that occur naturally as masses of strong, flexible fibers that can be separated into thin threads and woven. Asbestos has been widely used in many industrial products, including cement, brake linings, roof shingles, flooring products, textiles, and insulation. If tiny asbestos particles float in the air, especially during the manufacturing process, they may be inhaled or swallowed, and can cause serious health problems. In addition to mesothelioma, exposure to asbestos increases the risk of lung cancer, asbestosis (a non-cancerous, chronic lung ailment), and other cancers, such as those of the larynx and kidney.

Symptoms of mesothelioma may not appear until 30 to 50 years after exposure to asbestos. Shortness of breath and pain in the chest due to an accumulation of fluid in the pleura are often symptoms of pleural mesothelioma. Symptoms of peritoneal mesothelioma include weight loss and abdominal pain and swelling due to a buildup of fluid in the abdomen. Other symptoms of peritoneal mesothelioma may include bowel obstruction, blood clotting abnormalities, anemia, and fever. If the cancer has spread beyond the mesothelium to other parts of the body, symptoms may include pain, trouble swallowing, or swelling of the neck or face.

If you or someone you love has been diagnosed with Mesothelioma, please contact our service today. We can help put you in touch with experienced attorneys who are knowledgeable in this area and can help you with your claim.