LEGAL GUIDES FOR CONSUMERS ON DANGEROUS DRUGS

First approved in 2007, Tasigna (nilotinib), is a prescription medication used to treat chronic myeloid leukaemia (CML). Tasigna is part of a class of drugs known as tyrosine kinase inhibitors (TKIs). Other TKI drugs include Gleevec (imatinib), also made by Novartis, and Sprycel (dasatinib), made by Bristol-Myers Squibb.
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These drugs help treat leukemia by blocking the protein tyrosine kinases—a protein that stimulates the growth of cancer cells. In blocking this protein, TKI drugs like Tasigna help stop leukemia from spreading. Tasigna is prescribed as a twice daily drug and is taken orally in capsule form.

If you suffered Tasigna side effects, including Tasigna cardiovascular side effects, call Tasigna lawyer Timothy L. Miles today for a free case evaluation and see if you qualify for a Tasigna lawsuit.  If you are eligible for a Tasigna lawsuit, you could be entitled to significant compensation.

Read on to see if you may be eligible for a Tasignant lawsuit.

Injured patients and their families are now filing lawsuits against Tasigna manufacturer Novartis, on the grounds that the company failed to warn of the drug’s cardiovascular risks. Studies have allegedly linked the drug to serious cardiovascular side effects like Long QT syndrome, a condition involving irregular heartbeats, and atherosclerosis, a disease that causes plaque to build up in the arteries.​​

The FDA issued a black box warning (the highest warning they can issue) for Tasigna’s link to QT interval prolongation and sudden death. ​

​​To date, approximately 15,500 Tasigna related adverse events and 2,786 deaths have allegedly been reported to the FDA to date. These include serious Tasigna side effects including cardiovascular side effects, like Long QT syndrome, myocardial ischemia, and atherosclerosis.

Tasigna has one black box warning—the highest warning the FDA can issue—for Long QT syndrome, or QT interval prolongation, and sudden death. It is a condition that affects heart rhythm, resulting in fast, irregular heartbeats. If left untreated, it can result in fainting, seizures, and sudden death.

Tasigna may also been linked to myocardial ischemia, a condition involving reduced blood flow to the heart, causing a decreased amount of oxygen sent to the heart. Myocardial ischemia is usually caused by a blockage of the coronary arteries.

Recent lawsuits have also been filed over the drug’s alleged connection to atherosclerosis, a disease that causes fatty deposits to build up and eventually clog arteries. This serious condition gradually reduces blood flow and oxygen to cells.
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Atherosclerosis is currently the leading cause of death in the developed world. It may eventually cause the following complications:

• Coronary artery disease
• Peripheral arterial disease
• Blood clots
• Heart attacks
• Strokes

While Tasigna labels in Canada warn of a risk of developing atherosclerosis, in the U.S. injured patients allege Novartis has done little to warn of the condition.  If you suffered Tasigna side effects call Tasigna lawyer Timothy L. Miles for a free case evaluation to see if you are eligible for a Tasigna lawsuit.

​If you or a loved one took Tasigna and suffered heart or circulation problems (including complications like blocked arteries, heart attacks, or strokes), you could be eligible for a Tasigna lawsuit and possible entitled to substantial compensation. Call Tasigna lawyer Timothy L. Miles today for a free case evaluation to see if you are eligible for a Tasigna lawsuit.

If you are eligible for a Tasigna lawsuit and are successful, you can recover money for some of the following damages:
 

• Past and future medical bills (including medication, hospital stays, and in-home care)
• Pain and suffering
• Lost wages
• Loss of earning capacity
• Funeral expenses (in the event of a loved one’s death)

 
Broadly speaking, a plaintiff in a Tasigna lawsuit could be entitled to compensation for any past and future costs associated with their diagnosis if they qualify for a Tasigna lawsuit and are successful. ​

​​​​​Maintaining all your Tasigna documentation and other evidence is critical if you believe you are eligible for a Tasigna lawsuit. You will need this evidence to prove your case and that you are entitled to compensation in a Tasigna lawsuit.  Your Tasigna lawyer will determine what evidence best supports your claim, but you should maintain and start gathering all your Tasigna documents if you believe you are eligible for a Tasigna lawsuit, including:

• All your medical records, including bills, doctor notes, receipts and any other notes or documents
• Receipts and any other documents including dosage information relating to your Tasigna prescription
• All bank and other records evidencing your payments for doctor visits, prescriptions, medical tests and anything else you had to pay for in relation to your Tasigna prescription
• Any communications from the FDA or any other governmental agency concerning your Tasigna side effects 
• If a doctor, nurse or any other health care provider made any comments regarding your Tasigna side effects, write them down while they are still fresh on your mind
• Any other documentation or evidence you believe supports your claim that Tasigna caused your cancer circulation problems (including complications like blocked arteries, heart attacks, or strokes) or other serious Tasigna side effects 

​​If you or a loved one took Tasigna and suffered heart or circulation problems (including complications like blocked arteries, heart attacks, or strokes), you could be eligible for a Tasigna Lawsuit. If you suffered Tasigna side effects, including Tasigna cardiovascular side effects, call Tasigna lawyer Timothy L. Miles today for a free case evaluation and see if you qualify for a Tasigna lawsuit.

​​​A STAT News report and postmarketing studies raise questions about the adequacy of Actemra's safety warnings.
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STAT reviewed more than 500,000 adverse event reports on leading rheumatoid arthritis drugs, including Actemra, Humira, and Remicade. STAT found evidence that Roche downplayed Actemra’s cardiovascular, pancreatic, and lung side effects.
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According to STAT, from 2010 to 2016 the U.S. Food and Drug Administration (FDA) logged more than 13,500 Actemra adverse event reports, including 1,128 patients who died after taking Actemra.
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While safety data indicate the risks of heart attacks, strokes, heart failure, and interstitial lung disease are as high or higher for Actemra patients than for patients taking some similar drugs, Actemra’s warning label—unlike its competition's—does not reflect these risks.

For example, Actemra patients reported more cases of interstitial lung disease than Remicade patients, and nearly the same number as Humira patients. But while Remicade and Humira have interstitial lung disease warnings, Actemra does not.

STAT’s findings are supported by postmarketing studies—clinical studies conducted after a pharmaceutical product goes on the market to better understand drug risks.

The FDA ordered Actemra postmarketing studies because premarket testing revealed potentially worrisome side effects. One such study compared Actemra to another arthritis drug, Enbrel, and found rates of stroke and heart failure were about 1.5 times higher in Actemra users. Enbrel has strong warnings for patients with cardiovascular disease. Actemra does not have similar warnings despite similar or worse cardiovascular risks.

The takeaway from these findings is that doctors and patients may not be getting a complete picture of Actemra’s risk-benefit profile.

​Pharmaceutical products are not expected to be completely without harmful side effects. But if a drugmaker understands that a drug presents a certain risk, it has a duty to put an appropriate warning label on the product. That way patients and their doctors can evaluate all known risks and benefits and make an educated decision about whether a medication is right for them.

While the FDA has authority to demand warning labels, the responsibility ultimately falls on drug manufacturers. Actemra has garnered FDA attention since it was approved in 2010. At one point the agency considered a pancreatitis warning label. But Genetech/Roche talked the FDA out of the warning. The agency then approved broader use of Actemra for giant cell arteritis.

Conflicts of interest between manufacturers and regulators plague the drug safety system. The STAT report details how all 11 authors of an Actemra postmarketing study had financial ties to Roche or Genetech. And a former FDA manager who oversaw Actemra’s approval for rheumatoid arthritis now works for Roche, where he helps gain FDA approval for new uses of the drug.
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The drug safety system, in other words, cannot always be trusted to put patient safety first. That’s why, when patients suffer harm from drug side effects, they often must turn to the legal system.

​​We are looking into claims that Genetech/Roche failed to warn about the following Actemra side effects:

• Heart attack
• Heart failure
• Stroke
• Pancreatitis
• Interstitial lung disease (lung tissue scarring)

Actemra patients who suffered any of these Actemra side effects may be eligible for an Actemra lawsuit.

It does not cost anything to hire an Actemra lawyer.  We take all cases on a contingency basis which means we do not get paid unless we win your case.  An Actemra lawyer can explain the process and answer any questions you may have including whether you are eligible for an Actemra lawsuit.  

If you or a loved one suffered serious Actemra side effects including heart, lung, or pancreatic side effects while taking Actemra, contact Actemra lawyer Timothy L. Miles today to see if you are eligible for an Actemra lawsuit. If you meet the requirements for an Actemra lawsuit you may be entitled to substantial compensation.  ​​

​​Research shows Kombiglyze XR and other similar drugs may put patients at risk of heart complications. Dozens of patients are filing lawsuits against Kombiglyze’s manufacturer AstraZeneca and its previous partner Bristol-Myers Squibb alleging that the companies failed to adequately test the drugs’ safety prior to selling it, which ultimately caused their cardiovascular injuries.  If you suffered cardiovascular injuries after taking Kombiglyze or other serious Kombiglyze XR side effects call Kombiglyze lawyer Timothy L. Miles today for a free case evaluation to see if you are eligible for a Kombiglyze XR lawsuit.

​​Kombiglyze XR lawsuits allege that AstraZeneca and Bristol-Myers Squibb failed to:

• Warn the FDA, the medical community, and the general public of the cardiovascular risks associated with these drugs.
• Conduct adequate pre-clinical and clinical testing to determine if the drugs caused increased risks of cardiovascular injuries.
• Design the drugs so as to minimize certain adverse effects.
• Conduct adequate post-market monitoring of saxagliptin’s adverse events

If you or a loved one took Kombiglyze XR as directed and suffered from heart failure or other cardiovascular injuries—such as congestive heart failure or myocardial infarction, after starting Kombiglyze XR therapy, you may meet the requirements for a Kombiglyze XR lawsuit and possibly be entitled to substantial compensation. Call a Kombiglyze XR lawyer for free today who can tell you if you are eligible for a Kombiglyze XR lawsuit.

If you or a loved one took Kombiglyze XR as directed and suffered from Kombiglyze XR Side Effects, specifically: heart failure or other cardiovascular injuries—such as congestive heart failure or myocardial infarction, after starting Kombiglyze XR therapy, contact Kombiglyze XR lawyer Timothy L. Miles today to see if you are eligible for a Kombiglyze XR lawsuit and possibly entitled to substantial compensation. ​

Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin) belong to a new class of diabetic drugs known as DPP-4 inhibitors. Onglyza gained federal drug approval by the U.S. Food & Drug Administration (FDA) despite initial concerns over the cardiovascular safety of the drug.

These concerns were echoed in a post-marketing safety study that found Onglyza may be associated with an increased risk of heart failure and an increased risk of death.

If you or a loved one took Onglyza as directed and suffered from Onglyza side effects including heart failure or other cardiovascular injuries—such as congestive heart failure or myocardial infarction, after starting Onglyza therapy, contact Onglyza lawyer Timothy L. Miles today for a free case evaluation to see if you are eligible for an Onglyza lawsuit and possibly entitled to substantial compensation.

Read on for answers to five frequently asked questions about the Onglyza lawsuit.

​​Onglyza (saxagliptin) is an add-on medication to diet and exercise to improve blood sugar control in people with type 2 diabetes.  It is a is a dipeptidyl peptidase-4 (DPP-4) inhibitor that increases the amount of insulin your body makes. Onglyza comes in tablets in dosages of 2.5 mg and 5 mg taken once by mouth daily.

​​You should not take Onglyza if you are allergic to any of its ingredients. Serious allergic reactions can occur with Onglyza including swelling of the face, throat, lips and difficulty breathing, among others. Your doctor should test your blood to measure how well your kidneys work before and during treatment with Onglyza. You may need a lower dose of Onglyza if your kidneys are not working well.

​Type 2 diabetes patients have a significantly increased risk of cardiovascular complications, and the majority of diabetics die from such complications. Amid growing concerns over the safety of many diabetes drugs, in 2008 the FDA recommended that the makers of new type 2 diabetes drugs provide evidence that the drugs do not increase the risk of cardiovascular events such as heart attacks. 

Onglyza met the FDA's cardiovascular safety criteria. Though the FDA approved the new diabetic drug, it had reservations about the sufficiency of Onglyza clinical trials and ordered AstraZeneca to perform a post-marketing study. As a result, AstraZeneca completed a 16,000-patient cardiovascular outcomes trial called SAVOR. The results of that trial were published in the New England Journal of Medicine and raised major Onglyza safety concerns.

​SAVOR found that Onglyza patients were 27% more likely to be hospitalized for heart failure. The study also found a significant increase in the rate of “all-cause mortality” among Onglyza patients.
The warning signs of heart failure include:

• Shortness of breath
• Persistent cough or wheezing
• Swelling in the lower extremities or abdomen
• Fatigue
• Nausea
• Diminished appetite
• Impaired cognitive ability
• Increased heart rate

Following the release of SAVOR, the FDA issued an Onglyza drug safety communication and convened an advisory committee meeting to analyze the results and recommend further action. The committee voted 14-to-1 to add information to Onglyza’s label warning about heart failure risks. The other member voted to withdraw Onglyza from the U.S. market.

The committee, however, did not advise updating the warning label to address the measured increase in all-cause mortality among Onglyza patients and did not recommend any restrictions on prescribing the drug.

In an April 2016 drug safety communication, the FDA announced that Onglyza and Kombiglyze XR are now required to carry warnings about heart failure risk. Other FDA warnings about saxagliptin include:

• A warning about severe joint pain
• A warning about pancreatitis and pancreatic cancer

​​In addition to heart failure, Onglyza is linked to these adverse side effects:

• Severe joint pain
• Pancreatitis
• Pancreatic cancer
• Thyroid cancer
• Severe allergic reactions
• Hypoglycemia
• Upper respiratory tract infection
• Urinary tract infection

​​​If you or a loved one took Onglyza as directed and suffered suffered heart failure, death, or another serious cardiovascular injury, after starting Onglyza therapy, you may meet the requirements for an Onglyza lawsuit and possibly be entitled to substantial compensation. Call a Onglyza lawyer for free today who can tell you if you are eligible for an Onglyza lawsuit.

If you or a loved one took Onglyza as directed and suffered from Onglyza Side Effects, specifically: heart failure, death or another serious cardiovascular injury —such as congestive heart failure or myocardial infarction, after starting Onglyza therapy, contact Onglyza lawyer Timothy L. Miles today to see if you are eligible for a Onglyza lawsuit and possibly entitled to substantial compensation. ​

If you took Byetta and developed serious Byetta side effects, contact Byetta Lawyer Timothy L. Miles today about a Byetta Lawsuit

​​Byetta (exenatide) was the first of a new class drugs used to treat type 2 diabetes drugs known as glucagon-like peptide 1 (GLP-1) receptor agonists which generated a lot of early excitement with added benefits including a low risk of hypoglycemia and successful weight loss. However, early optimism was halted by reports that Byetta and similar drugs were a possible risk factor for pancreatitis and pancreatic cancer.​

There have been hundreds of pancreatic cancer lawsuits filed against the manufacturers of Byetta, Victoza, Janument, and Januvia.  These lawsuits were all transferred the Southern District of California by the Judicial Panel on Multidistrict Litigation for coordinated and pretrial discovery and proceedings.  A ruling by the trial judge in 2015 appeared to end the case until a recent court of appeals decision in favor of the Byetta plaintiffs holding their claims may proceed in federal court.

If you or a loved one took Byetta and were diagnosed with pancreatic cancer, contact Byetta lawsuit lawyer Timothy L. Miles today for a free case evaluation to see if you are eligible for Byetta lawsuit and possible entitled to substantial damages. (855) Tim-M-Law (855-846-6529).

Read on to learn what you need to know about the Byetta side effects.

​Byetta (exenatide) is a medicine used to treat type 2 diabetes. It is glucagon-like peptide-1 (GLP-1) receptor agonist.  A receptor agonist drug means that it binds to a certain receptor and causes the same action as the substance that normally binds to that receptor.  Byetta, by binding to and activating the GLP-1 receptor, tells your body to release more insulin, stops the body from releasing more sugar, and slows down digestion.

Byetta is a solution for injection available in pre‑filled pens of 5mcg or 10 mcg. The shots are given by the patient twice a day by injection under the skin in the abdomen, thigh or upper arm. ​The starting dose of Byetta is 5 mcg, twice a day before a meal.  After four weeks, the dose can be increased to 10 mcg depending ​on how well your blood sugar levels respond to Byetta injections.

Incretin mimetic drugs such as Byetta regulate the production of incretin, a type of hormone that stimulates the release of insulin in the body. Byetta does this by injecting patients with a substance that mimics a particular incretin called Glucagon-Like Peptide-1 (GLP-1).  Byetta lawsuits allege this process overstimulates the pancreas causing cells in the pancreas to multiply resulting in pancreatic cancer.

​​Byetta side effects include, among others:

• Pancreatic inflammation
• Pancreatitis
• Chronic pancreatitis
• Acute pancreatitis
• Necrotizing pancreatitis
• Hemorrhagic pancreatitis
• Pancreatic cancer
• Thyroid cancer
• Kidney damage
• Low blood-sugar (hypoglycemia)
• Nausea
• Vomiting
• Diarrhea
• Decreased appetite
• And more

Certain people can have an allergic reaction after taking Byetta. The symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (warmth and redness in your skin)

A more severe allergic reaction to Byetta is rare but possible.  The symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing
• chest tightness

You should call your doctor right away if you have a severe allergic reaction to Byetta or suffer other severe Byetta side effects and if your symptoms feel life threatening you should call 911.

​A number of scientific studies support plaintiff claims that Byetta causes pancreatic cancer.

• In 2010, researchers wrote in the journal Diabetes Care that “there is a plausible risk that long-term recipients of GLP-1-based therapy may develop asymptomatic pancreatitis… and worse, a minority of individuals treated by this class of drugs may develop pancreatic cancer.”
• Research published in 2011 in the journal Gastroenterology found a reported event rate for pancreatic cancer that was 2.9 times greater in patients treated with Byetta compared to those treated with other diabetes medications.
• Adverse event data from the Drug Commission of the German Medical Association found an unusually high incidence of pancreatic cancer associated with Byetta. The data showed an average of 12.2 months between the start of treatment with Byetta and a diagnosis of pancreatic cancer.
• A case-controlled epidemiological study on the effect of GLP-1 drugs on the pancreas published in JAMA in 2013 concluded that an association between GLP-1s and pancreatitis “may be causal.” This is significant because antecedent pancreatitis is the most common risk factor for subsequent pancreatic cancer.

​​​Pancreatitis, an inflammation of the pancreas, can cause the following symptoms, among others:

• Severe upper abdominal pain which may radiate through the back
• Nausea
• Vomiting
• High blood pressure (hypertension)
• Low blood pressure (hypotension)
• Elevated heart or respiratory rates

It is not known for certain if Byetta or other similar incretin mimetic diabetes drugs can cause pancreatic cancer. However, Incretin mimetics treat type 2 diabetes by mimicking the action of GLP-1, a hormone that stimulates the pancreas to produce more insulin.  In certain people, this could possibly cause chronic inflammation of the pancreas, also known as pancreatitis, which is a known risk factor for pancreatic cancer.

​​​If you meet the following criteria, you may be eligible for a Byetta lawsuit:

• You were prescribed Byetta for type-2 diabetes and took the drug as directed
• You developed pancreatic cancer after starting Byetta therapy
• Pancreatic cancer caused you to suffer damages (such as medical expenses and loss of income)

​Plaintiffs may also seek claims related to the wrongful death of a loved one who was prescribed Byetta and developed fatal pancreatic cancer.

It does not cost anything to hire a Byetta lawyer.  We take all cases on a contingency basis which means we do not get paid unless we win your case.  A Byetta lawyer can explain the process and answer any questions you may have including whether you are eligible for a Byetta lawsuit.

​A Byetta Lawsuit is a demand from the defendants for monetary compensation by patients who took Byetta and subsequently developed serious Byetta Side Effects. The lawsuits allege the defendants made a defective drug and failed to warn physicians about its carcinogenic properties. If you suffered Byetta Side Effects​ and are eligible for a Byetta lawsuit, you may possibly be entitled to substantial compensation. A Byetta Lawsuit Lawyer can answer these questions and is available anytime just give us a call or submit this form for a free case evaluation to see if you are eligible for a Byetta lawsuit. ​

​​​​Because of the complexity of the cases and the need to hire experts, a products liability attorney is the go-to attorney when you have been injured by a drug or a product that is defective like Byetta.  A Byetta Lawsuit Lawyer, who is an experienced products liability attorney, can help you by putting you in the best possible position to win your Byetta Lawsuit and recover the most compensation if you are eligible for a Byetta lawsuit.