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.