Tag: severe bleeding

Pradaxa Side Effects:  Internal Bleeding, Cardiovascular Risks Outweigh Benefits

The FDA approved anticoagulant Pradaxa in October 2010. The blood thinner soon became a blockbuster riding on manufacturer Boehringer Ingelheim’s claim that it was 35 percent more effective than its nearest competitor Warfarin. However, within weeks of its approval Pradaxa side effects topped the list of the FDA adverse reporting system. By 2011, the federal regulator had received more than 4,300 Pradaxa side effects complaints, including 542 reports of deaths, according to the Institute of Safe Medication Practices. Pradaxa side effects are linked to irreversible internal bleeding, heart strokes, hemorrhages, kidney dysfunction, and vascular problems that resulted in hundreds of deaths and injuries.

Pradaxa Internal Bleeding Risks

Pradaxa oral anticoagulant leads to inhibition of thrombin enzyme, which plays a key role in clotting blood in the body. As the drug effectively suppresses these enzymes, the human body lacks ability to prevent bleeding in time of need. In 2011, the FDA received 2,367 reports of Pradaxa-induced internal bleeding. Excessive bleeding, internal or external, aggravates and results in death. In case of other blood thinners, Vitamin K is used to check bleeding. However, there is also no medication available that can reverse the anticoagulant effects of Pradaxa.

The most common types of internal bleeding caused by Pradaxa side effects include bleeding from gums, frequent nose bleeding, and blood in urine and stool. Many patients also experience some symptoms, such as vomiting blood, coughing up blood, and unusual bleeding from bruises. According to the Randomized Evaluation of Long-Term Anti-coagulation Therapy test published in the New England Journal, Dabigatran, the main element of Pradaxa, enhances the risk of internal bleeding by 16 percent compared with Warfarin.

Pradaxa leads to severe dyspepsia and gastrointestinal bleeding. Tartaric acid in the drug reduces the pH level for better absorption. This results in stomach ache and mild to severe gastrointestinal bleeding. Patients already using non-steroidal anti-inflammatory medication are more likely to experience severe gastrointestinal problems when prescribed the drug. It has also been found that rectal bleeding caused by Pradaxa side effects puts patients with renal impairment at an enhanced risk of kidney failure.

According to the Journal of Neurosurgery, brain hemorrhage can be fatal for patients using Pradaxa. The drug badly alters the Thrombin Time and International Normalized Ratio or INR that impact the blood clotting activity in the event of hemorrhage. This enables bleeding to quickly spread and push brain injury patients into coma, as no antidote is available to reverse Pradaxa side effects. Intracranial bleeding due to Pradaxa side effects puts senior citizens at a greater risk of death with bumps on the forehead as the most visible symptom.

Pradaxa Cardiovascular Risks

The FDA has received many reports of myocardial infarction in patients taking Pradaxa. According to the European Society of Cardiology, the risk of dyspepsia and gastrointestinal bleeding caused by Pradaxa side effects puts patients at significantly increased danger of myocardial infarction and heart attacks. The findings were supported by a report published in the January 2012 issue of the American Heart Association Journal. A detailed study published in the American College of Cardiology Journal in February 2012 also highlighted that patients treated with Pradaxa therapy could be more susceptible to thromboembolic complications and strokes.

According to WebMD, one of the best online medical resources, Pradaxa is 30 percent more likely to cause stroke and cardiovascular side effects than other blood thinners on the market. Patients with mechanical heart valves, persistent deep vein thrombosis, and valvular diseases must refrain from using the drug, as it may endanger their lives. Researchers have also discovered that suddenly discontinuing or missing Pradaxa doses may cause considerable decrease in the anticoagulant characteristics of blood, which poses a greater risk of pulmonary embolism, thrombosis, and heart stroke. Pericardial and intra-articular bleedings are other common vascular side effects of the drug.

Pradaxa Risks Outweigh Benefits?

Though clinical trials have shown its superior efficacy for patients with atrial fibrillation, Pradaxa seems to be posing severe risk to patients. Pradaxa side effects render it impossible for blood to clot during hemorrhages. The rising number of Pradaxa lawsuits, complaints, and independent studies across the world pose serious questions on the safety of patients treated with the drug. Pradaxa side effect warnings and label changes following investigations by health regulators in Canada, Europe, Japan, New Zealand, and the United States indicate many areas where the dangers outweigh benefits, putting patients at the risk of health hazards.

About Pradaxa

Pradaxa, also known as Dabigatran Etexilate Mesylate, is an anti-coagulant drug commonly prescribed to prevent blood clots and strokes in patients with Atrial Fibrillation, a heart rhythm disorder. Because it is designed to prevent clots from forming, patients taking the drug may have a difficult time stopping bleeding from minor cuts. The drug can also effect bruising in the case of a fall, as it may cause internal bleeding (bruising) that continues to grow.

Benefit vs. Risk

Any anti-coagulant drug runs the risk of causing excessive bleeding, due to its effect on the blood. It is part of a delicate balancing act physicians and drug companies must handle: know when the benefits outweigh the risks. Before any drug is approved, drug companies must show that the benefits of taking the drug outweigh any potential side effects. Physicians must evaluate individual patients conditions and determine if their specific situation merits taking a drug with potential risk. In addition, drug companies and physicians must provide adequate warning of potential risks of any drug.

Specific Risks of Pradaxa

Reading the side effects of any drug can be an eye-opening experience as many medicines designed to benefit also have the potential of causing harm. As with any drug, Pradaxa has a list of possible side effects. What is alarming about Pradaxa is the growing number of reported cases of those “rare” side effects actually taking place. In December, 2011, the Food and Drug Administration (FDA) put the drug under review for safety concerns. Some of the specific concerns include:

• Bleeding Gums
• Vomiting or coughing up blood
• Blood in stool
• Blood in urine
• Severe bleeding
• Excessive menstrual bleeding
• Excessive nose bleeds

However, beyond the scope of these concerns, there are growing reports of side effects from Pradaxa that have been severe enough to require hospital care. Hemorrhage is a common complaint in these cases. In fact, the January issue of the Journal of Neurosurgery discussed the case of an 83 year old patient who died after using Pradaxa for four weeks. His death was caused by a Pradaxa-induced brain injury. The journal warned of the potential for more such cases. Brain hemorrhaging is not the only concern, gastrointestinal hemorrhage is another common complaint in Pradaxa cases.

Getting Help

If you feel helpless to take your case against a large pharmaceutical company, our skilled lawyers are ready to help. We have been actively monitoring developments in Pradaxa related events and are prepared to assist you. We understand your concerns and will work on your behalf to get the legal recourse you deserve.

CALL: 1-800-632-1404

EMAIL: clicking here

FILL OUT THIS FORM FOR A FREE CONSULTATION AND CASE EVALUATION:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

The exceptionally high number of Pradaxa side effect complaints within months of its market introduction and rising number of Pradaxa lawsuits have effectively blunted the “wonder drug” tag attached to it by manufacturer Boehringer Ingelheim. A number of studies have highlighted the high-rate thromboembolic problems and internal bleeding associated with the anticoagulant, while many have questioned the approval of Pradaxa given by the FDA in the absence of any proven antidote. Warnings by the FDA and European drug regulators have resulted in serious debate over the benefit versus risks of the drug.

Independent Studies Questioning Pradaxa Side Effects

In December 2011, the FDA had acknowledged to have initiated an investigation into post-marketing reports highlighting internal bleeding, brain hemorrhage, gastrointestinal bleeds, and death caused by Pradaxa side effects. The drug was introduced with tall claims about a year ago. The FDA also sought for label updates on the drug by manufacturer Boehringer Ingelheim with immediate effect to apprise users of the irreversible internal bleeding caused by Pradaxa side effects.

According to the Monitoring MedWatch Reports, a meta-analysis of the complaints through to the FDA adverse reporting system by the Institute for Safe Medication Practices and published in October 2011, there were 307 Pradaxa side effect complaints within the first three months of the introduction of the drug in the market, which was higher than any other type of medication monitored. MedWatch received 932 more complaints in the first quarter of 2011. This included at least 120 reports of death and over 500 reports of internal bleeding.

Pradaxa users also face an increased risk of heart strokes, thromboembolic complications, and number of vascular problems, according to the American College of Cardiology Journal. A study published on February 14th, 2012, warned that constant internal bleeding caused by Pradaxa side effects could lead to 16 percent higher incidence of thromboembolic complications or heart attacks when compared to other blood thinners. Researchers interviewed 290 atrial fibrillation patients using various blood thinners. A Reuters report in June 2012 also highlighted the rising concern among the healthcare professionals regarding Pradaxa cardiovascular risks.

In October 2011, Therapeutics medical journal published a study that casted serious questions on the approval of Pradaxa anticoagulant. According to researchers from the University of British Columbia , the clinical safety assessment was fundamentally wrong, biased, and full of errors, as it was based on a comparison between Pradaxa and Warfarin. A September 2012 report in the Journal of the American Medical Association also questioned fast tracking Pradaxa approval without considering unavailability of any antidote.

The Archives of Internal Medicine published a new Pradaxa study by European researchers in September 2012. A meta-analysis of seven studies, it claimed that the latest blood thinners, including Pradaxa, could provide any substantial benefit because of potential health hazards they became. The study took cognizance of more than 30,000 acute coronary syndrome patients treated with anticoagulants at placebo stages, clinical trials, and post-marketing phase. Researchers found that Pradaxa and similar blood thinners moderately reduced the risks of thrombosis and heart problems but tripled the risk of bleeding events.

The British regulatory agency, the Prescription Medicines Code of Practice Authority, PMCPA, accused Boehringer Ingelheim of violating the pharmaceutical code of conduct in December 2011. According to the PMCPA, the manufacturer misled consumers and doctors on Pradaxa safety information and failed to warn them adequately about bleeding hazard caused by it.

Pradaxa Side Effects: What To Do

In 2011, there were 3,781 Pradaxa side effect reports filed with the FDA. This was in additional to 542 reports of death caused by the drug. Internal bleedings, including GI bleeding and brain hemorrhage, topped the list with 2,367 cases, while 644 patients using the drug suffered from heart attacks. At least 291 people reportedly suffered kidney impairment after using the drug. The post-marketing reports also highlighted many patients suffering from adverse effects because of missed doses and unusual bleeding. Pradaxa users must contact doctors immediately if they are experiencing any symptoms, such as bleeding, gastrointestinal problems, or heart problems. A thorough checkup is also advised if they suffer from a sudden fall. Those already suffering from the drug side effects can contact lawyers to evaluate their case for filing a Pradaxa lawsuit.

Do I Have A Lawsuit

Warnings by health regulators worldwide and a number of independent studies affirm that Pradaxa is not a “wonder drug” as claimed by its manufacturers. Lack of any antidote to neutralize its anticoagulant effects puts patients treated with the drug at a greater risk of hemorrhage and death. If you or any of your relatives have suffered from Pradaxa side effects, you have every right to sue the drug maker and seek compensation for the injury, suffering, and medical treatment cost. Contact a Pradaxa lawyer to evaluate your case and file a drug injury lawsuit.

About Pradaxa

Pradaxa, also known as Dabigatran Etexilate Mesylate, is an anti-coagulant drug commonly prescribed to prevent blood clots and strokes in patients with Atrial Fibrillation, a heart rhythm disorder. Because it is designed to prevent clots from forming, patients taking the drug may have a difficult time stopping bleeding from minor cuts. The drug can also effect bruising in the case of a fall, as it may cause internal bleeding (bruising) that continues to grow.

Benefit vs. Risk

Any anti-coagulant drug runs the risk of causing excessive bleeding, due to its effect on the blood. It is part of a delicate balancing act physicians and drug companies must handle: know when the benefits outweigh the risks. Before any drug is approved, drug companies must show that the benefits of taking the drug outweigh any potential side effects. Physicians must evaluate individual patients conditions and determine if their specific situation merits taking a drug with potential risk. In addition, drug companies and physicians must provide adequate warning of potential risks of any drug.

Specific Risks of Pradaxa

Reading the side effects of any drug can be an eye-opening experience as many medicines designed to benefit also have the potential of causing harm. As with any drug, Pradaxa has a list of possible side effects. What is alarming about Pradaxa is the growing number of reported cases of those “rare” side effects actually taking place. In December, 2011, the Food and Drug Administration (FDA) put the drug under review for safety concerns. Some of the specific concerns include:

• Bleeding Gums
• Vomiting or coughing up blood
• Blood in stool
• Blood in urine
• Severe bleeding
• Excessive menstrual bleeding
• Excessive nose bleeds

However, beyond the scope of these concerns, there are growing reports of side effects from Pradaxa that have been severe enough to require hospital care. Hemorrhage is a common complaint in these cases. In fact, the January issue of the Journal of Neurosurgery discussed the case of an 83 year old patient who died after using Pradaxa for four weeks. His death was caused by a Pradaxa-induced brain injury. The journal warned of the potential for more such cases. Brain hemorrhaging is not the only concern, gastrointestinal hemorrhage is another common complaint in Pradaxa cases.

Getting Help

If you feel helpless to take your case against a large pharmaceutical company, our skilled lawyers are ready to help. We have been actively monitoring developments in Pradaxa related events and are prepared to assist you. We understand your concerns and will work on your behalf to get the legal recourse you deserve.

CALL: 1-800-632-1404

EMAIL: clicking here

FILL OUT THIS FORM FOR A FREE CONSULTATION AND CASE EVALUATION:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

Pradaxa Side Effects Put Patients at Increased Health Risk

Following the FDA warning and revelations by a number of studies about Pradaxa side effects, there has been a marked increase in the number of litigations over the drug. Manufacturer Boehringer Ingelheim is facing more than 200 Pradaxa lawsuits at various federal and state courts in the United States, and the number is likely to go up, as lawyers are considering more potential claims. In August 2012, an Illinois federal court dismissed a petition by Boehringer seeking dismissal of Pradaxa injury lawsuits on the ground that prior warnings by the manufacturer about bleeding problems were not enough to dismiss side effect litigations filed by the drug users.

Pradaxa Lawsuits

The first federal Pradaxa lawsuit was filed on March 7, 2012, in the Tennessee eastern district court by daughter of a woman who died in 2011 following severe internal bleedings. According to the plaintiff, her mother was admitted to a hospital in March for gastrointestinal bleeding within two months of using Pradaxa. She died shortly as the bleeding becomes severe and could not be checked. The Pradaxa lawsuit claims that manufacturer Boehringer Ingelheim was liable for the wrongful death, as it failed to provide safety information to doctors and patients on handling gastrointestinal bleeding events successfully. It was soon followed by five more cases filed in Louisiana, Kentucky, Oklahoma, and Tennessee courts. In April 2012, another Pradaxa lawsuit representing family of a woman, who bled to death following the drug side effects, was filed in the Western District Court of Tennessee.

Six more Pradaxa lawsuits claiming wrongful death and product liability were filed against Boehringer in May 2012. The first one filed in an Illinois federal court represented family of a woman, who was prescribed the drug for non-valvular atrial fibrillation. She died in October 2011 because of uncontrollable internal bleeding. Another lawsuit was filed by the family of a Tennessee man. He died in May 2011 after Pradaxa side effects led to excessive gastrointestinal bleeding that could not be checked despite surgery.

The number of Pradaxa lawsuits had crossed 100 by the end of July 2012. On July 25, an Illinois federal judge dismissed a motion filed by Boehringer to reject all injury claims on the ground that the drug maker warned users about internal bleeding risks caused by the drug. The judge agreed with the plaintiffs that the manufacturer had failed to adequately inform and educate consumers and doctors about safety concerns associated with Pradaxa.

In August, the MDL panel consolidated 120 federal Pradaxa lawsuits filed across the country at the court of Illinois Southern District Judge David R. Herndon. The panel transferred 40 lawsuits from different federal courts to Illinois. There are at least 15 more Pradaxa lawsuits pending in the state courts. One lawsuit filed in an Illinois state court by 70 plaintiffs has sought class action status. Judge Herndon selected 27 lawyers to represent the Plaintiffs’ Leadership Counsel in various capacities in the last week of September.

The court has set a deadline of March 2013 for parties to propose the process for selecting plaintiffs. The first federal Pradaxa trial is scheduled for August 11, 2014. Among the state Pradaxa lawsuits, a Connecticut will hear the first one on September 22, 2014.

Common Complaints and Grounds of Pradaxa Lawsuits

• Product Liability: Majority of Pradaxa lawsuits sue the Boehringer Ingelheim for its inability to warn about the drug side effects. The manufacturer failed to adequately inform healthcare professionals and users about the risk of Pradaxa internal bleeding and lack of an antidote to check it.
• Wrongful Death: Most of the lawsuits represent family members of persons, who died following Pradaxa side effects. These include cases of internal bleeding, gastrointestinal bleeding, heart attacks, and brain hemorrhage following accidental fall.
• Serious Side Effects: Those suffering from internal bleeding, cardiovascular problems, renal impairment, and neurological disorders caused by Pradaxa side effects are also entitled to file lawsuits seeking compensation.

Do I Have A Lawsuit

Warnings by health regulators worldwide and a number of independent studies affirm that Pradaxa is not a “wonder drug” as claimed by its manufacturers. Lack of any antidote to neutralize its anticoagulant effects puts patients treated with the drug at a greater risk of hemorrhage and death. If you or any of your relatives have suffered from Pradaxa side effects, you have every right to sue the drug maker and seek compensation for the injury, suffering, and medical treatment cost. Contact a Pradaxa lawyer to evaluate your case and file a drug injury lawsuit.

About Pradaxa

Pradaxa, also known as Dabigatran Etexilate Mesylate, is an anti-coagulant drug commonly prescribed to prevent blood clots and strokes in patients with Atrial Fibrillation, a heart rhythm disorder. Because it is designed to prevent clots from forming, patients taking the drug may have a difficult time stopping bleeding from minor cuts. The drug can also effect bruising in the case of a fall, as it may cause internal bleeding (bruising) that continues to grow.

Benefit vs. Risk

Any anti-coagulant drug runs the risk of causing excessive bleeding, due to its effect on the blood. It is part of a delicate balancing act physicians and drug companies must handle: know when the benefits outweigh the risks. Before any drug is approved, drug companies must show that the benefits of taking the drug outweigh any potential side effects. Physicians must evaluate individual patients conditions and determine if their specific situation merits taking a drug with potential risk. In addition, drug companies and physicians must provide adequate warning of potential risks of any drug.

Specific Risks of Pradaxa

Reading the side effects of any drug can be an eye-opening experience as many medicines designed to benefit also have the potential of causing harm. As with any drug, Pradaxa has a list of possible side effects. What is alarming about Pradaxa is the growing number of reported cases of those “rare” side effects actually taking place. In December, 2011, the Food and Drug Administration (FDA) put the drug under review for safety concerns. Some of the specific concerns include:

• Bleeding Gums
• Vomiting or coughing up blood
• Blood in stool
• Blood in urine
• Severe bleeding
• Excessive menstrual bleeding
• Excessive nose bleeds

However, beyond the scope of these concerns, there are growing reports of side effects from Pradaxa that have been severe enough to require hospital care. Hemorrhage is a common complaint in these cases. In fact, the January issue of the Journal of Neurosurgery discussed the case of an 83 year old patient who died after using Pradaxa for four weeks. His death was caused by a Pradaxa-induced brain injury. The journal warned of the potential for more such cases. Brain hemorrhaging is not the only concern, gastrointestinal hemorrhage is another common complaint in Pradaxa cases.

Getting Help

If you feel helpless to take your case against a large pharmaceutical company, our skilled lawyers are ready to help. We have been actively monitoring developments in Pradaxa related events and are prepared to assist you. We understand your concerns and will work on your behalf to get the legal recourse you deserve.

CALL: 1-800-632-1404

EMAIL: clicking here

FILL OUT THIS FORM FOR A FREE CONSULTATION AND CASE EVALUATION:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

Pradaxa Side Effects Put Patients at Increased Health Risk

 

Pradaxa side effects have been linked to over 542 deaths caused by excessive internal bleeding and at least 3,781 health-related complaints reported to the FDA’s adverse reporting system over the last two years. The blood thinner, claimed to be more effective compared to similar medications, has surprisingly generated more consumer complaints than any other drug in the US market within a short span of its introduction. Manufacturer Boehringer Ingelheim has been facing hundreds of lawsuits accusing the drug maker of failure to inform users of serious Pradaxa side effects, including cerebral bleeding, hemorrhagic stroke, pericardial bleeding, and renal impairment.

 

Important Pradaxa side effects

• Internal Bleeding

Life-threatening internal bleeding is the most common of Pradaxa side effects. People prescribed the drug are likely to suffer from coughing up or vomiting blood, frequent nose bleeding, unusual bruising, bleeding from gums, and blood in urine and stool. The external bleeding can also aggravate in patients taking the drug. Intracranial and extracranial bleeding caused by Pradaxa puts seniors at the risk of death. It inhibits thrombin enzyme, responsible for blood clotting, and prevents blood from clot, leading to death in some cases. There is no medicine available to stop hemorrhage caused by Pradaxa side effects.

• Gastrointestinal Bleeding

According to a research, one in every seven Pradaxa users face the risk of gastrointestinal bleeding. While it can be serious in case of 3.3 percent users, 1.5 percent users face the risk of fatal internal bleeding. Tartaric acid in Pradaxa brings down the gastric pH level, which results in dyspepsia or uncomfortable feeling in stomach. Persistent dyspepsia increases the risk of gastrointestinal bleeding. Those already taking non-steroidal anti-inflammatory drugs also face enhanced risk of GI bleeding on administration of Pradaxa.

• Heart Stroke

A meta-analysis published by the American Heart Association in January 2012 confirmed the enhanced risk of heart attacks associated with Pradaxa side effects. The drug increases the risk of myocardial infarction, which results in mild to severe heart strokes. A research report in the American College of Cardiology Journal (Feb, 2012) found that Pradaxa raises thromboembolic complications, strokes, and bleeding risks than other blood thinners. According to WebMD, the risk is as high as 35 percent compared to Warfarin, another popular blood thinner. Intra-articular bleeding and pericardial bleeding are among the most reported vascular disorders caused by the drug. There were at least 644 cases of heart attacks caused by Pradaxa side effects in 2011.

• Brain Hemorrhage

A report published in the Journal of Neurosurgery in March 2012 highlighted death of an 83-year-old man using Pradaxa from brain hemorrhage. He was hospitalized after a minor fall and died within 24 hour, as doctors failed to check bleeding in the brain. He was on Pradaxa therapy for the last one month after suffering from atrial fibrillation. The blood thinner drug left him with far less International Normalized Ratio and Thrombin Time, effectively preventing blood clotting and worsening hemorrhage.

• Kidney Impairment

Pradaxa side effects cause renal impairment and aggravate existing kidney problems. The drug poses serious problems for elderly patients suffering from kidney ailments and results in kidney failure. Persistent rectal bleeding aggravates the problem and as the kidney is unable to process the drug, its rising level puts patients at a greater risk of complications.

The post-marketing reports have also highlighted neurological disorders, such as headache, dizziness, and exhaustion, in patients taking Pradaxa. Bleeding from the gums, swelling of ankles and joints, nose bleeds, and weakness of hands and feet are also common in patients taking the drug. There is no drug that can check the anti-coagulant effects of Pradaxa.

FDA Warnings

In December 2011, the FDA began an investigation into Pradaxa side effects following reports of a high number of deaths and health problems associated with the drug. A month later, it ordered manufacturer Boehringer to update drug label warning to inform consumers about bleeding risks and to start a comprehensive safety review of the drug. Similar actions were soon taken by drug regulators in Canada, Japan, New Zealand, and many European countries. In some European countries, health regulators have advised doctors to screen kidney patients before prescribing them the drug. Research studies and complaints highlighting Pradaxa side effects are pouring and lawsuits by those suffering from its adverse effects continue to rise.

 

About Pradaxa

Pradaxa, also known as Dabigatran Etexilate Mesylate, is an anti-coagulant drug commonly prescribed to prevent blood clots and strokes in patients with Atrial Fibrillation, a heart rhythm disorder. Because it is designed to prevent clots from forming, patients taking the drug may have a difficult time stopping bleeding from minor cuts. The drug can also effect bruising in the case of a fall, as it may cause internal bleeding (bruising) that continues to grow.

Benefit vs. Risk

Any anti-coagulant drug runs the risk of causing excessive bleeding, due to its effect on the blood. It is part of a delicate balancing act physicians and drug companies must handle: know when the benefits outweigh the risks. Before any drug is approved, drug companies must show that the benefits of taking the drug outweigh any potential side effects. Physicians must evaluate individual patients conditions and determine if their specific situation merits taking a drug with potential risk. In addition, drug companies and physicians must provide adequate warning of potential risks of any drug.

Specific Risks of Pradaxa

Reading the side effects of any drug can be an eye-opening experience as many medicines designed to benefit also have the potential of causing harm. As with any drug, Pradaxa has a list of possible side effects. What is alarming about Pradaxa is the growing number of reported cases of those “rare” side effects actually taking place. In December, 2011, the Food and Drug Administration (FDA) put the drug under review for safety concerns. Some of the specific concerns include:

• Bleeding Gums
• Vomiting or coughing up blood
• Blood in stool
• Blood in urine
• Severe bleeding
• Excessive menstrual bleeding
• Excessive nose bleeds

However, beyond the scope of these concerns, there are growing reports of side effects from Pradaxa that have been severe enough to require hospital care. Hemorrhage is a common complaint in these cases. In fact, the January issue of the Journal of Neurosurgery discussed the case of an 83 year old patient who died after using Pradaxa for four weeks. His death was caused by a Pradaxa-induced brain injury. The journal warned of the potential for more such cases. Brain hemorrhaging is not the only concern, gastrointestinal hemorrhage is another common complaint in Pradaxa cases.

Getting Help

If you feel helpless to take your case against a large pharmaceutical company, our skilled lawyers are ready to help. We have been actively monitoring developments in Pradaxa related events and are prepared to assist you. We understand your concerns and will work on your behalf to get the legal recourse you deserve.

CALL: 1-800-632-1404

EMAIL: clicking here

FILL OUT THIS FORM FOR A FREE CONSULTATION AND CASE EVALUATION:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

Things To Know About Pradaxa Blood Thinner Drug Side Effect and Lawsuits

Pradaxa, generic name Dabigatran, is an oral anticoagulant drug manufactured by German pharmaceutical Boehringer Ingelheim. The blood thinner drug was introduced in October 2010, with the manufacturer claiming that it was superior to Warfarin, the then most sold drug in the same category. Pradaxa is prescribed to patients with atrial fibrillations or those with hip or knee replacement surgeries to prevent blood clots and strokes. Health regulators in the United States, Canada, Japan, and many European countries are investigating Pradaxa health risks reported in various studies and adverse event reporting systems. Litigations against the manufacturer are gaining momentum following the FDA discloser of investigations into health risks posed by the drug side effects in December 2011.

Studies on Pradaxa Side Effects and Efficacy

A drug safety report published by the Institute of Safe Medication Practices in January 2012 claimed that Pradaxa led to significant increase in hemorrhages, internal bleeding, and consequent death in users. Another study published in the American College of Cardiology Journal, a month later, warned that the drug increases the risk of thromboembolic complications, strokes, and internal bleeding by 16 percent compared to Warfarin. In March, the New England Journal of Medicine published a study highlighting hemorrhage, bleeding, cerebral, and cardiovascular risks associated with the drug in the absence of any effective reversal agent to contain Pradaxa side effects.

Pradaxa Complaints and FDA Warning

The FDA Adverse Event Reporting System received at least 932 Pradaxa side effect complaints, including 120 death reports and 505 reports on internal bleeding, in the first three months of 2011, according to the Institute for Safe Medication Practices. There was a significant increase in the number of Pradaxa complaints to the FDA in 2011 and these far exceeded any other blood thinner-related complaint. By the end of the year, 542 deaths and 3,781 complaints, including 2,367 bleedings, 644 heart attacks, and 291 cases of kidney impairment, had been reported.

In January 2012, the FDA concerned at the rising number of Pradaxa side effect complaints began an investigation into the adverse event reports. A month later, it ordered the manufacturer to update the label warnings on the drug and carry out a safety assessment based on post-marketing reports.

A press release issued by the British Prescription Medicines Code of Practice Authority on March 12, 2012, criticized Boehringer Ingelheim for calling Pradaxa a “wonder drug.” According to the regulatory body, the false efficacy claims by the manufacturer were against the British pharmaceutical industry code of practice. The agency also alleged that the manufacturer knowingly avoid warning people about Pradaxa bleeding side effects earlier.

Public health regulators in Japan, Canada, and many European nations have sought updated labels on the drug warning about potential health risks and advised health practitioners to screen patients for kidney problems prior to prescribing Pradaxa.

Pradaxa Side Effects and Injuries

According to post-marketing reports and independent investigations, Pradaxa side effects led to 260 deaths in the last two years, which is five times higher than reported by the drug manufacturer. The most common Pradaxa side effects include internal bleedings, such as bleeding from the gums, heavy menstrual bleeding, blood coughing, vomiting blood, and blood in urine. It also causes frequent nose bleeds and uncontrolled external bleeding worsening bruises.

Pradaxa lowers the gastric pH level when absorbed. This puts patients at the risk of dyspepsia and gastrointestinal bleeding. Seniors prescribed with the drug are likely to develop extracranial bleeding symptoms. Myocardial infarction associated with Pradaxa side effects result in mild to severe heart attacks and strokes. The conditions of patients with prior renal impairment are likely to deteriorate with the drug side effects. Post-marketing data has also highlighted persistent stomach pain in Pradaxa users.

Pradaxa Lawsuits

Pradaxa has been subject to litigations ever since the FDA ordered an investigation into post-marketing reports highlighting health risks posed by the drug side effects in December 2011. Manufacturer Boehringer Ingelheim has been facing an increasing number of Pradaxa lawsuits filed by US patients suffering from heart problems, internal bleedings, kidney impairment, and other serious side effects of the drug. The personal injury lawsuits have alleged that failure of the manufacturer to adequately research and warn patients of Pradaxa side effects made them to suffer from wrongful death, life-threatening hemorrhages, and other complications.

In August 2012, the MDL panel assigned 120 Pradaxa lawsuits filed in different federal courts to Judge David R. Herndon of Illinois southern district court for consolidated trial. On September 27, the court appointed 27 Pradaxa lawyers to the Plaintiffs’ Leadership Counsel, making it the largest ever in the US legal history. About 15 more Pradaxa lawsuits have been pending in California, Connecticut, and other state courts.

About Pradaxa

Pradaxa, also known as Dabigatran Etexilate Mesylate, is an anti-coagulant drug commonly prescribed to prevent blood clots and strokes in patients with Atrial Fibrillation, a heart rhythm disorder. Because it is designed to prevent clots from forming, patients taking the drug may have a difficult time stopping bleeding from minor cuts. The drug can also effect bruising in the case of a fall, as it may cause internal bleeding (bruising) that continues to grow.

Benefit vs. Risk

Any anti-coagulant drug runs the risk of causing excessive bleeding, due to its effect on the blood. It is part of a delicate balancing act physicians and drug companies must handle: know when the benefits outweigh the risks. Before any drug is approved, drug companies must show that the benefits of taking the drug outweigh any potential side effects. Physicians must evaluate individual patients conditions and determine if their specific situation merits taking a drug with potential risk. In addition, drug companies and physicians must provide adequate warning of potential risks of any drug.

Specific Risks of Pradaxa

Reading the side effects of any drug can be an eye-opening experience as many medicines designed to benefit also have the potential of causing harm. As with any drug, Pradaxa has a list of possible side effects. What is alarming about Pradaxa is the growing number of reported cases of those “rare” side effects actually taking place. In December, 2011, the Food and Drug Administration (FDA) put the drug under review for safety concerns. Some of the specific concerns include:

• Bleeding Gums
• Vomiting or coughing up blood
• Blood in stool
• Blood in urine
• Severe bleeding
• Excessive menstrual bleeding
• Excessive nose bleeds

However, beyond the scope of these concerns, there are growing reports of side effects from Pradaxa that have been severe enough to require hospital care. Hemorrhage is a common complaint in these cases. In fact, the January issue of the Journal of Neurosurgery discussed the case of an 83 year old patient who died after using Pradaxa for four weeks. His death was caused by a Pradaxa-induced brain injury. The journal warned of the potential for more such cases. Brain hemorrhaging is not the only concern, gastrointestinal hemorrhage is another common complaint in Pradaxa cases.

Getting Help

If you feel helpless to take your case against a large pharmaceutical company, our skilled lawyers are ready to help. We have been actively monitoring developments in Pradaxa related events and are prepared to assist you. We understand your concerns and will work on your behalf to get the legal recourse you deserve.

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