A Florida man’s lawsuit against Novartis AG, alleging the pharmaceutical company’s leukemia medication Tasigna caused him to suffer a stroke, was permitted to proceed according to a recent ruling.

The plaintiff, Dennis M., says he began taking Tasigna back in 2001, and alleges his stroke in 2013 was the direct result of exposure to Tasigna over the years. According to the Tasigna stroke lawsuit, Dennis was not given adequate warning of the risks associated with Tasigna, including the risk of stroke.

While Novartis argued that it could not have added a stroke warning to Tasigna’s label without approval from the U.S. Food and Drug Administration (FDA), the judge found that there is no clear evidence that a proposed stroke warning would have been rejected by the federal agency. Therefore, the Tasigna stroke lawsuit has been allowed to move forward, despite Novartis’ attempts to have it dismissed.

Background of Tasigna

Tasigna (also sold under the generic name nilotinib) is a treatment for leukemia specifically approved to treat chromosome-positive chronic myeloid leukemia cancer. Tasigna is manufactured by Novartis, and was approved by the U.S. Food and Drug Administration (FDA) in 2007. Tasigna is part of a class of drugs known as tyrosine kinase inhibitors.

Tasigna is now one of the most widely used cancer drugs available—in fact, in 2016 alone, Tasigna brought in $1.7 billion in sales. Unfortunately, despite its popularity, Tasigna has been associated with some severe complications.

Alleged Side Effects of Tasigna

More and more patients are claiming that they were not given adequate warning about the risks of Tasigna, including stroke and atherosclerosis.

Essentially, when a patient suffers atherosclerosis, their artery walls thicken and plaque builds up, limiting essential blood flow and causing peripheral vascular disease. Peripheral vascular disease, sometimes known as peripheral arterial disease (PAD), can involve symptoms including cramping, pain, or tiredness, as well as difficulty walking or climbing stairs. With rest, the symptoms of peripheral vascular disease often lessen, but resuming physical activity once again sparks symptoms.

The loss of blood circulation from peripheral vascular disease can become a serious risk, that may even leading to major cardiovascular issues. In extreme cases, when the artery becomes totally blocked from peripheral vascular disease, patients may suffer from gangrene or require limb amputation. A carotid artery affected by peripheral vascular disease may result in a stroke.

A post market review from the FDA noted that its findings “strongly suggest an association between nilotinib (Tasigna) and PAOD (peripheral arterial occlusive disease)”. The FDA released its findings in 2013, and as a result, Novartis updated its Black Box warning label for Tasigna to include the risk of peripheral vascular disease. However, the drug had been available for years before this risk was added to the warning label.

Some patients claim that Novartis was aware of the risk of Tasigna side effects, yet failed to warn the public and the medical community about these risks for a substantial period of time.

Filing a Tasigna Lawsuit

If you or someone you love has suffered from Tasigna side effects like stroke or other complications, you may be able to file a Tasigna stroke lawsuit against Novartis. Filing a lawsuit cannot take away the pain and suffering caused by these side effects, but it can help to alleviate the financial burden caused by medical expenses and lost wages.