Empr.com reports that Tasigna has received approval from the Food and Drug Administration (FDA) for use in patients over the age of one, who has been diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase. Tasigna, which is the brand name of nilotinib, is manufactured by Novartis. The drug is already approved for treatment of adults with the same condition.
The approval only applies to pediatric patients who cannot tolerate or are resistant to tyrosine kinase inhibitor therapy. Studies indicate that pediatric patients experience side-effects similar to what adults experience, but that the long-term impact is still not known.
Tasigna has been usedsince receiving FDA approval in 2007, but it has recently been subject to Tasigna atherosclerosis lawsuits because patients have developed severe and permanent atherosclerosis conditions after taking the drug.
Tasigna already has a black box warning because it can cause QTc prolongation, which is a serious, life-threatening condition that causes an irregular heartbeat. Atherosclerosis is a condition where plaque builds-up on a patient’s arterial walls. This can cause a blockage of blood flow. One patient who took the medication stated that he suffered a stroke because of the damage was done by Tasigna. The build-upof plaque can also cause blood clots. Patients do not usually experience symptoms until their arteries are so restricted that blood cannot get to the organs in adequate amounts. Strokes are a possible consequence of this condition, as are heart attacks.
The label used to sell Tasigna in Canada reportedly does include a warning about the drug’s possible connection to atherosclerosis-related conditions.