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FDA Issues Warning About Lung Inflammation and Use of CDK4/6 Inhibitors

By: Sarah Jackson
Posted: Thursday, September 19, 2019

On September 13, 2019, the U.S. Food and Drug Administration (FDA) issued a drug safety communication warning that palbociclib, ribociclib, and abemaciclib—used to treat some patients with advanced breast cancer—may cause rare but severe inflammation of the lungs. The FDA has approved new warnings about this risk to the prescribing information and patient package insert for the entire class of these cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. The FDA noted that the overall benefit of CDK4/6 inhibitors still outweigh the risks when used as prescribed.

Patients should notify their health-care professional immediately if they have any new or worsening symptoms involving their lungs, as they may indicate a rare but life-threatening condition. Symptoms to watch for include difficulty or discomfort with breathing and shortness of breath while at rest or with low activity.

Health-care professionals should monitor patients regularly for pulmonary symptoms indicative of interstitial lung disease and/or pneumonitis. Signs and symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams in patients in whom infectious, neoplastic, and other causes have been excluded. Treatment with CDK4/6 inhibitors should be interrupted in patients who have new or worsening respiratory symptoms, and it should be permanently discontinued in patients with severe interstitial lung disease and/or pneumonitis.

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