Tasigna, also known generically as nilotinib, is a chemotherapy drug used to treat chronic myeloid leukemia (CML). Globally speaking, Tasigna is a bestseller among drugs for CML treatment, with its manufacturer gaining upwards of $2 billion in sales revenue during 2016.

Novartis AG Pharmaceutical Company, the Switzerland-based developer of Tasigna, has recently come under fire for the drug’s side effects which allegedly include atherosclerosis, peripheral artery occlusive disease, and other cardiovascular issues which could have fatal consequences such as heart attack, and stroke. Several lawsuits have been filed that threaten the drug’s popularity for CML treatment.

Tasigna was approved for CML treatment by the U.S. Food and Drug Administration (FDA) in 2007.

While the drug oversight agency was aware of other potential side effects at the time and issued a black box warning on the label for those, the FDA did not require a similar warning for other potential side effects like arterial swelling and interior plaque build-up. These side effects grossly interfere with the body’s ability to adequately distribute necessary blood supply.

Several Studies Show Tasigna’s Cardiovascular Risks

The first connection that scientific research made between Tasigna and quickly-developing atherosclerosis was made four years after the CML treatment was approved by the FDA.

In 2011, a study was published whose results indicated that roughly one out of every four patients prescribed Tasigna were diagnosed later with circulatory issues. Some of these issues progressed into full peripheral arterial occlusion.

Close to 10 other studies were published in 2013, including a post-market review requested by the FDA. This review weighed adverse medical event reports from the U.S., and research from Canada, Europe, and the U.S. with respect to Tasigna and CML treatment.

The conclusion offered by the FDA was that there was a preponderance of data indicating a probable relationship between Tasigna and peripheral artery occlusive disease as well as other cardiovascular risks.

After this conclusion was publicly disclosed by the FDA, a black box warning was added to the Tasigna’s label. This label change came after the CML treatment had been on the market for several years and was a little late for those that experiences some of these severe side effects.

In addition to the warning’s lack of punctuality, the FDA didn’t send out information regarding these findings to prescribing medical professionals or the public.  A good number of people remained on the medication because of this lack of action.

This was not the case in Canada. When the manufacturer changed the label in this country, an announcement was sent to prescribers. This allowed them to make informed decisions as to whether to initiate or stop treatment with some or all patients with Tasigna.

Several lawsuits have been filed against Novartis that allege the company knew about Tasigna’s potential cardiovascular side effects long before they chose to indicate these in any label change. The manufacturer has been accused of concealing information while aggressively continuing to promote its treatment value as superior.

If you or a loved one has suffered a stroke, heart attack, tissue death, or amputation because of this CML treatment, filing a lawsuit can help recover medical expenses and provide compensation for pain and suffering. Fill out our form today to request a free initial consultation of your case.