Research shows the anticancer drug dasatinib—sold under the brand name Sprycel—causes heart-related side effects.
The Rottenstein Law Group compassionately advocates for those who have suffered Sprycel side effects. If you’ve taken Sprycel and believe it left you vulnerable to heart-related side effects, contact RLG for a free, confidential legal consultation immediately. We will evaluate your case and remain on the lookout for Sprycel recalls and Sprycel class action lawsuits.
What Is Sprycel and What Is It Prescribed For?
Sprycel is the brand name for the drug dasatinib. Made and sold by American pharmaceutical company Bristol-Myers Squibb, Inc., this prescription medication is used to treat three conditions: Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML); chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML if imatinib treatment proves ineffective; and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The U.S. Food and Drug Administration (FDA) approved the drug in June 2006. Doctors can prescribe the drug in 20 mg to 140 mg daily doses in the form of oral tablets.
CML is often caused by an abnormal chromosome formation called the “Philadelphia chromosome,” which forms when the Abelson (Abl) tyrosine kinase gene on the 9th chromosome fuses with the break point cluster (Bcr) gene on the 22nd chromosome. Tyrosine kinase is an enzyme that helps control cell division. When mutated, tyrosine kinase can be permanently switched “on,” causing rampant, cancerous cell growth. Sprycel is a member of the Bcr-Abl and Src family of tyrosine-kinase inhibitors, so it prevents the tyrosine kinase from causing cancer growth.
Sprycel Might Cause Heart-Related Side Effects
Pulmonary Arterial Hypertension
In October 2011 the FDA issued a Sprycel warning in the form of a Drug Safety Communication, alerting the public that Sprycel can increase the risk of pulmonary arterial hypertension (PAH). PAH is characterized by abnormally high blood pressure in the arteries that pump blood to the lungs for oxygenation. This causes the heart to work harder to pump the same amount of blood to the lungs, which weakens the heart tissue. Symptoms of PAH include:
- Dyspnea (shortness of breath);
- Hypoxia (inadequate oxygenation of blood); and
- Swelling in extremities (such as the ankles and legs).
Onset of symptoms can occur even after one year of initiating treatment, and in many circumstances users were taking other medications or had other contributing heart problems. The FDA knows of 12 cases of Sprycel users who developed PAH, none of them died as a result of the condition. Doctors can rule out other causes of PAH symptoms by conducting right heart catheterizations of patients. In October 2011, Bristol-Myers Squibb updated the drug’s label to include a Sprycel pulmonary arterial hypertension warning.
If you took the medication and suffered any of these symptoms, contact a Sprycel lawyer at the Rottenstein Law Group.
Congestive Heart Failure, Left Ventricular Dysfunction, and Myocardial Infarction
In a 258-person Sprycel clinical trial, 5.8 percent of the participants reported “cardiac adverse reactions,” including 1.6 percent of them suffering cardiomyopathy, congestive heart failure, diastolic dysfunction, fatal myocardial infarction, and left ventricular dysfunction.
Sprycel can prolong the “QT interval,” a segment of the human heartbeat as defined in terms of electrical impulses. This “QT interval prolongation” can indicate a type of irregular heartbeat called “Torsades de Pointes,” and it is a risk factor for sudden death. Fifteen patients out of 2,440 in a Sprycel clinical trial developed QT prolongation.
Myelosuppression is the decrease in the bone marrow’s creation of various blood cells that carry oxygen, enable blood clotting, and protect the body from infection. Often a side effect of chemotherapy, which attacks all rapidly dividing cells and not just cancerous ones, Sprycel myelosuppression can cause thrombocytopenia (platelet shortage), neutropenia (white blood cell shortage), and anemia (hemoglobin shortage).
Bleeding Related Events
Severe Sprycel thrombocytopenia correlates with hemorrhages. In clinical studies, one percent of Sprycel users suffered central nervous system hemorrhages, which included fatalities. Four percent suffered severe gastrointestinal hemorrhages, which also included some fatalities. Other cases of severe hemorrhage occurred in two percent of users in clinical trials.
In Sprycel clinical trials, up to ten percent of participants suffered from severe fluid retention, including one percent that developed severe pulmonary edema.
RLG’s Sprycel Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The Sprycel lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Sprycel lawsuit on your behalf if necessary. RLG will also keep you up to date on any Sprycel class action lawsuits, FDA Sprycel warnings, and Sprycel FDA recall announcements. If you have taken Sprycel and believe it harmed you, contact RLG today.