Sprycel® Lawsuit | Sprycel Lawyer, Sprycel Attorney

October 11, 2011 — The leukemia drug Sprycel (generic: dasatinib) may increase the chances of pulmonary arterial hypertension (PAH), a rare but serious condition causing high blood pressure in the lungs, the FDA says. Serious side effects of PAH may include chest pain, body swelling and even possible death.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Sprycel induced injury cases in all 50 states. If you or somebody you know has been injured by Sprycel, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Dangerous Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Detailed Overview

Manufactured by Bristol-Myers Squibb, Sprycel (dasatinib) was approved by the US Food and Drug Administration (FDA) in June 2006 to treat adult patients with specific kinds of leukemia, including Philadelphia chromosome-positive chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL). It belongs to a class of drugs known as protein-tyrosine kinase inhibitors; it works by blocking a protein that signals cancer cells to multiply, grow and spread.

Recently, however, the FDA warned Sprycel may increase risks of pulmonary arterial hypertension (PAH), a rare but serious condition characterized by high blood pressure in arteries of the lungs.

PAH forces the heart to work much harder in pumping blood into the lungs. As a result, the heart becomes overworked and may become weak, losing its ability to pump enough blood through the lungs.

Because of the elevated risk of PAH, the FDA is adding information to the Warnings and Precautions section of the Sprycel drug label. As of June 2011, the FDA estimates over 32,882 patients worldwide have been exposed to Sprycel since its initial approval.

Due to the severity of Sprycel induced PAH, you or someone you know who took Sprycel and developed PAH may want to contact a Sprycel lawyer or attorney with The Schmidt Firm, PLLC to discuss the potential for a Sprycel lawsuit.

Sprycel Side Effects and PAH Symptoms

Symptoms of pulmonary arterial hypertension, or PAH, include:

Shortness of breath (especially while exercising)
Fatigue
Swelling of the body (especially the ankles and legs)
Chest pain
Chest pressure
Tiredness
Racing heartbeat
Fainting spells
Dizziness
Bluish color to your lips and skin
Fluid retention

FDA Study and Results

There have been several cases of pulmonary arterial hypertension identified in the database of Bristol-Myers Squibb, the manufacturer of Sprycel.

The manufacturer and FDA report that there have been at least 12 confirmed cases of PAH. While many of the patients were taking other medications simultaneously as Sprycel, Sprycel was identified as the most likely cause of the PAH condition.

Said the FDA about the reports:

“Patients developed PAH after receiving Sprycel therapy for various time intervals, including more than one year.”

The FDA cautioned that there may be multiple factors contributing to the development of PAH, but doctors saw an improvement in patients with PAH after they discontinued Sprycel therapy.

What is Pulmonary Arterial Hypertension?

Pulmonary arterial hypertension is increased pressure in the pulmonary arteries, which carry blood from the heart to the lungs to be oxygenated. The pulmonary arteries become blocked, narrowed or destroyed. As a result, it becomes harder for the heart to push blood through the arteries and into the lungs.

The heart begins to work harder than normal, causing the right ventricle to become strained and weak. When this occurs, the heart may become so weak that it can’t pump enough blood into the lungs, which may lead to heart failure and death.

On average in the United States, there are 1,000 new cases of PAH diagnosed each year. It is twice as common in females as in males.

Currently, there is no cure for PAH, but medicines, therapies and procedures can help relieve symptoms and slow the progress of the disease.

Sprycel Treatments

Sprycel is used to treat certain types of leukemia, a form of cancer in the white blood cells. It is often prescribed to patients who are no longer benefiting from other leukemia drugs like Gleevec. It may also be prescribed if patients are experiencing too severe of side effects from these other drugs.

Additionally, Sprycel may be prescribed for other off-label treatments.

FDA Recommendations

The FDA provided these following recommendations to patients who may be taking Sprycel or may be thinking of starting Sprycel therapy:

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.

Along with other similar warnings, the FDA advised healthcare professionals that:

Patients should be evaluated for signs and symptoms of underlying cardiopulmonary disease prior to initiating Sprycel and during treatment.
If PAH is confirmed, Sprycel should be permanently discontinued.

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