The FDA is ordering drug-makers to update the labels on several medications for advanced breast cancer after finding a rare but severe risk of lung inflammation side effects.
The medications include Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib), which are used in combination with hormone therapies to treat certain types of advanced breast cancer.
Patients on these medications should tell their doctor right away if they have any new or worsening lung problems, as they may be symptoms of a life-threatening condition that could lead to death.
These symptoms include difficulty breathing, discomfort with breathing, and shortness of breath while at rest or with low activity, according to the FDA.
The FDA is also asking healthcare professionals to monitor patients for signs of Interstitial Lung Disease (ILD) and/or pneumonitis.
The risk is relatively low, but serious cases of lung inflammation and deaths were reported during clinical trials for Ibrance, Kisqali, and Verzenio.
Across clinical trials, 1% to 3% of patients had ILD/pneumonitis of any grade. Less than 1% had fatal outcomes, but some patients who died had no risk factors for lung disease, according to the FDA.