Sprycel (generic: dasatinib), commonly used to treat leukemia patients, has recently been linked to increased risks of pulmonary arterial hypertension (PAH), a serious condition that causes high blood pressure in arteries of the lungs. While rare, PAH may cause chest pain, shortness of breath and may even be deadly.
Do I Have a Sprycel Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one have taken Sprycel and been diagnosed with pulmonary arterial hypertension, you should contact our lawyers immediately. You may be entitled to compensation by filing a Sprycel lawsuit.
Sprycel Overview
The FDA approved Sprycel (dasatinib) in June 2006 as a cancer drug that treats adult patients with various forms of leukemia, including Philadelphia chromosome-positive chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL). It is manufactured by Bristol-Myers Squibb and belongs to a group of drugs known as protein-tyrosine kinase inhibitors.
Sprycel works by blocking certain proteins that signal cancer cells to multiply. It is often used to treat leukemia in patients who have stopped responding to other cancer-treating drugs.
In total, the FDA estimates over 32,882 patients worldwide have been exposed to Sprycel, as of June 2011.
Unfortunately, in October 2011, the FDA warned Sprycel may actually cause a rare, but serious condition known as pulmonary arterial hypertension, which is characterized by high blood pressure in the arteries of the lungs.
When the arteries become blocked, the heart has to work harder in order to pump blood into the lungs. The heart becomes overworked and may become weak, leading to possible heart failure.
Due to the severity of PAH caused by Sprycel, you or someone you know who used Sprycel and developed PAH may want to contact a Sprycel lawyer or attorney with The Clark Firm for a free consultation to discuss the potential for a Sprycel lawsuit.
Symptoms of Pulmonary Arterial Hypertension
The following may be signs or symptoms of possible pulmonary arterial hypertension, or PAH:
- Shortness of breath (especially while exercising)
- Fatigue
- Swelling of the body (including the ankles and legs)
- Chest pain
- Chest pressure
- Tiredness
- Racing heartbeat
- Fainting spells
- Dizziness
- Bluish color to your lips and skin
- Fluid retention
Pulmonary Arterial Hypertension and the FDA
Pulmonary arterial hypertension (PAH) is the increased pressure in the pulmonary arteries. During PAH, the arteries — which carry blood from the heart to the lungs for oxygen — become blocked, narrowed or destroyed.
This makes it more difficult for the heart to push blood through the arteries and into the lungs, causing the heart to work harder than usual. As a result, the right side of the heart (the right ventricle) may become strained or weakened. It can become so weak that it causes potential heart failure or not enough blood to be pumped into the lungs.
Each year, there are an average of 1,000 new cases of PAH diagnosed in the United States, with cases being twice as common in women than in men.
In October, the FDA released a Drug Safety Communication, notifying the healthcare community that there have been 12 confirmed cases of PAH reported in the database of Bristol-Myers Squibb, the manufacturer of Sprycel.
While many of the patients who developed PAH were taking other medications simultaneously as Sprycel, the FDA pinpointed Sprycel as the most likely cause of the condition. The FDA noted that the patients developed PAH after receiving Sprycel therapy for various time intervals, including more than one year.
While medicines, surgeries and other therapies may cause relief from symptoms and may slow the development of the disease, there is currently no cure for PAH.
Due to the severity of the condition, the FDA is updating the information on the Warnings and Precautions portion of the Sprycel label to reflect the risk of PAH.
FDA Recommendations
The FDA has the following recommendations for patients who may be taking or thinking of taking Sprycel:
- Symptoms of PAH include shortness of breath, fatigue, and swelling of the body (such as the ankles and legs). Patients who develop these symptoms should notify their healthcare professional right away.
- Patients should talk to their healthcare professional if they have any questions or concerns about Sprycel.
- Patients should report serious side effects from the use of Sprycel to the FDA MedWatch program.
Sprycel and Leukemia
Sprycel is prescribed to patients suffering from certain types of leukemia, a cancer of the white blood cells. Most notably, Sprycel treats Philadelphia chromosome-positive chronic myeloid leukemia and acute lymphoblastic leukemia.
Often times, Sprycel is prescribed to patients who were taking other leukemia-treating drugs, but have stopped responding to treatment or have developed too severe of side effects from the drugs.
In more rare cases, Sprycel may be prescribed for other off-label treatment options.
Other Side Effects of Sprycel
Sprycel may cause other less serious side effects, including:
- Headache
- Muscle pain
- Tiredness
- Weakness
- Dizziness
- Joint pain
- Pain, burning or tingling in the hands or the feet
- Skin rash
- Skin redness
- Peeling skin
- Swelling, redness and pain inside the mouth
- Mouth sores
- Diarrhea
- Nausea
- Vomiting
- Constipation
- Stomach pain or swelling
- Loss of appetite
- Weight loss
Do I Have a Sprycel Lawsuit?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact us for a free Sprycel lawsuit review or you may also call us directly by dialing (866) 879-3040.