Sprycel (generic: dasatinib) is a prescription medication intended for cancer treatment. More specifically, Sprycel was developed to halt the progression of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML). Unfortunately, recent studies suggest that Sprycel treatment may coincide with catastrophic side effects. Patients who take Sprycel may significantly increase their risk of developing pulmonary arterial hypertension (PAH), a rare and serious condition in which there is an abnormally high blood pressure in the arteries and lungs.
If you or a loved one has been injured by Sprycel, you should contact our lawyersimmediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
Sprycel Lawsuit Overview
The U.S. Food and Drug Administration (FDA) approved of Sprycel, a Bristol Myers Squibb product, on June 28, 2006. After nearly five years, the cumulative worldwide exposure to Sprycel is estimated to be 32,882 patients, based on the total sales volume between initial approval in June 2006 and June 2011. During that time, Sprycel served as a viable treatment option for those diagnosed with CML.
Dasatinib, Sprycel’s main active ingredient, is in a class of medications known as protein-tyrosine kinase inhibitors. As a protein-tyrosine kinase inhibitor, dasatinib regulates the activity of numerous proteins. More specifically, Sprycel impairs the functions typically exhibited by BCR-ABL, a protein affiliated with the uncontrolled growth of CML cells. Therefore, the reduction of BCR-ABL activity may result in the suppression of CML cell growth.
Unfortunately, Sprycel treatment may not demonstrate a favorable risk/benefit profile. Scientific literature suggests that dasatinib may serve as a potential mechanism in which patients experience severe, life-threatening complications. Patients who take Sprycel may drastically increase their risk of developing pulmonary arterial hypertension (PAH), a condition characterized by potentially fatal blood pressure abnormalities. Due to the severity of PAH, patients may contact a Sprycel lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation of their potential Sprycel lawsuit.
Sprycel Side Effects
The following is a list of Sprycel side effects:
- Low red blood cell counts (anemia)
- Low white blood cell counts (neutropenia)
- Low platelet counts ( thrombocytopenia)
- Severe bleeding
- Severe fluid retention
- Decreased level of consciousness
- Swelling
- Weight gain
- Shortness of breath
- Abnormal heart rate
- Heart attack
- Pulmonary arterial hypertension (PAH)
- Death
Sprycel Pulmonary Arterial Hypertension
The following FDA Drug Safety Communication acknowledges that Sprycel may be responsible for patients developing pulmonary arterial hypertension:
The U.S. Food and Drug Administration (FDA) is warning the public that the leukemia drug Sprycel (dasatinib) may increase the risk of a rare, but serious condition in which there is abnormally high blood pressure in the arteries of the lungs (pulmonary arterial hypertension [PAH]). Information about this risk has been added to the Warnings and Precautions section of the Sprycel drug label.
Pulmonary arterial hypertension is characterized by the narrowing of the arteries that lead to the lung. Subsequently, the restricted passageway is unable to transport a sufficient amount of blood. The impeded circulation creates an abnormally high blood pressure that puts a significant amount of strain on the heart. As a result, the heart is forced to work harder to force the blood through the vessels against the building pressure. Over time, the overworked heart muscle may become weak and lose its ability to pump enough blood through the lungs. Unfortunately, severe circumstances may lead to heart failure and eventually death.
Currently, there is no known treatment for patients diagnosed with PAH. Doctors may only control the symptoms to prevent further damage to the lung. Due to the severity of PAH, expectations are usually tempered and the long-term outlook has been poor. However, treatments currently under development may lead to better results in the future.
FDA Sprycel Data Summary
According to a recent FDA Data Summary, numerous cases of pulmonary arterial hypertension have been associated with the use of Sprycel. Data obtained from Bristol-Myers Squibb’s global pharmacovigilance database confirms at least 12 distinct cases of PAH. According to the database, a right heart catheterization identified Sprycel as the most likely cause. Patients developed PAH after receiving Sprycel therapy for various time intervals, including circumstances that lasted longer than one year.
Do I Have a Sprycel Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Sprycel lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by Sprycel, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.