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Amid increasing emerging safety concerns about the potential artherosclerosis side effects of Tasigna, federal regulators have decided to allow expanded use of the leukemia drug among children.
Last month, the FDA approved the use of Tasigna for pediatric patients 1 year old or older who have been newly diagnosed with Philadelphia chromosome positive chronic myeloid leukemia. The approval is for those patients “in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy.”
The FDA granted approval based on two open-label multi-center trials involving 69 pediatric patients.
Tasigna (nilotinib) was first 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 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, a recent Tasigna lawsuit alleges that Novartis should have also provided strong warnings about the potential risk of artherosclerosis, which may lead to a stroke, heart attack, amputations or death.
The lawsuit indicated that the drug can result in the constricting and hardening of arteries. It claims that Novartis has known of the problem 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.
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.
The FDA notes that the safety profile for pediatric patients is similar to that of adults, with common adverse reactions including hyperbilirubinemia, thrombocytopenia, rash, neutropenia, lymphopenia, alanine aminotransferase (ALT) increased, headache, anemia, pyrexia, nausea, upper respiratory tract infection, aspartate aminotransferase increased, and vomiting.
The agency is recommending a pediatric dose of 230 mg/m2 orally twice daily, with a maximum single dose of 400 mg.
The FDA urges healthcare professionals to report any serious adverse events suspected to be linked to the drug to the FDA MedWatch adverse event reporting system.