Tasigna Stroke Lawsuit Filed Over Failure to Warn About Atherosclerosis Risks

According to a product liability lawsuit filed last month against Novartis, inadequate warnings are being provided about the risk that side effects of Tasigna may result in constricting and hardening of arteries, alleging that the cancer drug used to treat chronic myeloid leukemia (CML) caused a Washington man to suffer a stroke.

The complaint (PDF) was filed by Bruce Becker in the U.S. District Court for the Western District of Washington, indicating that Novartis knew about the potential Tasigna risks, since it placed proper warnings on the drug labels in Canada, yet failed to provide the same information for users and medical providers in the United States.

Tasigna (nilotinib) was approved by the FDA in 2007, and is part of a class of drugs known as kinase inhibitors, which are prescribed for treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) among recently diagnosed adults. It is also approved for the treatment of chronic phase and accelerated phase Ph+ CML in adults who are resistant or intolerant to prior therapy.

The drug currently carries a black box warning about the risk of QT prolongation, which is a heart rhythm problem that can result in sudden death. However, the Tasigna lawsuit alleges that Novartis should have also provided strong warnings about the potential artherosclerosis side effects, which may lead to a stroke, heart attack, amputations or death.

“Novartis failed to warn of risks that Tasigna caused several forms of severe, accelerated and irreversible atherosclerosis-related conditions – i.e., the narrowing and hardening of arteries delivering blood to the arms, legs, heart, and brain,” Becker’s lawsuit states. “Despite warning doctors and patients in Canada of the risks of atherosclerosis-related conditions, Novartis intentionally failed to warn United States doctors and patients of these risks.”

Becker indicates that he was prescribed Tasigna for the treatment of CML, after treatments with another cancer drug, Gleevec, put him into remission. However, he claims that side effects of Tasigna, caused him to rapidly develope atherosclerosis-related conditions that resulted in a stroke at the age of 66.

The lawsuit indicates that Novartis was aware of the Tasigna stroke risk since at least 2010, following reports by clinical investigators who identified side effects in patients that included hardening and narrowing of arteries that supply blood to the legs and arms, heart and brain. These conditions can be life threatening and can result in heart attacks, strokes, the need for amputations and death, the lawsuit states.

In April 2013, Novartis issued a warning to Canadian health professionals and the Canadian public following an investigation by Health Canada; that nations drug regulatory agency. However, no similar notification or warning was provided to doctors and patients in the U.S., the lawsuit claims.

Becker’s complaint presents claims of strict product liability and negligence. Becker seeks both compensatory and punitive damages.