US FDA Warns Of Rare Heart/Lung Problem With Bristol-Myers Drug

US FDA Warns Of Rare Heart/Lung Problem With Bristol-Myers Drug

October 12th, 2011 // 12:53 pm @

The U.S. Food and Drug Administration said a Bristol-Myers Squibb Co. (BMY) leukemia drug could increase the risk of a rare high-blood pressure problem in the lungs called pulmonary arterial hypertension.

In a drug-safety communication posted on the FDA’s website Tuesday, the agency said the label for the drug, Sprycel, has been updated to warn of the risk of pulmonary arterial hypertension, which causes the heart to work harder to pump blood into the lungs. Over time, the heart muscle can become weak and lose its ability to properly pump blood.

Sprycel was approved in 2006 to treat certain types of adult chronic myeloid leukemia and acute lymphoblastic leukemia, which are blood and bone-marrow cancers. The FDA said about 33,000 patients worldwide have been treated with Sprycel. The drug is designed to inhibit proteins responsible for the growth of cancer cells, allowing bone marrow to begin producing normal red and white blood cells.

The FDA said cases of pulmonary arterial hypertension, or PAH, were found in a Bristol-Myers Squibb database that is designed to track reports of side-effects potentially related to the company’s prescription drugs. The FDA said patients who developed PAH were taking other medications in addition to Sprycel and had other underlying illnesses that might have contributed to the development of PAH. The agency said the condition might be reversible if use of Sprycel is stopped.

Symptoms of pulmonary arterial hypertension, according to the FDA, include shortness of breath, fatigue and swelling of the body, most likely in the arms and legs.

The FDA said doctors should evaluate patients for signs of cardiopulmonary disease before starting treatment with Sprycel and during treatment.


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