Side Effects of Breast Cancer Drugs Ibrance, Kisqali, Verzenio May Cause Lung Inflammation: FDA

  • Written by: Irvin Jackson

Federal drug regulators warn that the side effects of Ibrance, Kisqali and Verzenio may increase the risk of severe lung inflammation among users of the breast cancer drugs.

The FDA issued a drug safety communication on September 13, announcing that new label warnings will be required for a class of advanced breast cancer medications, known as cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors. According to the agency, the entire class increases the risk of rare, but severe inflammation of the lungs.

Ibrance (palbociclib), Kisqali (robociclib), and Verzenio (abemaciclib) are used in combination with hormone therapies to treat some forms of advanced or metastatic breast cancer which has spread to other parts of the body. The first, Ibrance, was approved by the FDA in 2015. Kisqali and Verzenio were approved in 2017.

According to clinical trial data, one to three percent of patients taking the drugs will develop the inflammation. Less than one percent of cases to date have been fatal.

The FDA indicates it has approved new warnings about the lung inflammation risks which will be added to the drugs’ prescribing information and Patient Package Insert. It is also advising doctors to monitor patients taking these drugs regularly for pulmonary symptoms which look like interstitial lung disease (ILD) or pneumonitis. Symptoms can include:

  • Hypoxia
  • Cough
  • Dyspnea

Interstitial filtrates on radiological exams for patients where other causes have been eliminated.

The FDA recommends that doctors who see these symptoms pause treatment with the drugs in patients with respiratory problems, and permanently remove the therapy for patients with severe ILD or pneumonitis.

The agency recommends patients taking the drug let their health care professional know immediately if they develop new or worsening lung problems, including difficulty or discomfort breathing, and shortness of breath when at rest or after low activity.

The FDA indicates that it believes the benefits of these drugs still outweigh the risks and recommends patients do not stop taking the medications without first talking to their health care professional.

Doctors and patients are encouraged to report any adverse events or side effects to the FDA’s MedWatch adverse event reporting program.

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  1. Pamela Reply

    I am one of the 1-3% who developed ILD while on Ibrance and both my oncologist and the pulmonologist immediately noted the connection between the two. If there are any class action suits against the drug company, I would like to know about it.

  2. wasif Reply

    Hello Pamela, sorry to hear that, my mom also suffered severe lung inflammation and acute pneumonia within 1 week of starting Ibrance. I am also interested to find if a potential lawsuit can be filed

  3. William Reply

    My wife was on Ibrance for 3 weeks and was off for almost 1 week when she she developed a couch shortness of breath dizzy and had fallen the night before I had to call 911 to have her transported to the hospital where she died from respiratory failure. I would also like to know if lawsuit was started.

  4. Carrie Reply

    I have also suffered from the debilitating side affects of the drug Ibrance !

  5. Ladonna Reply

    My mom was on Verzenio and has developed severe lung inflammation and is on a ventilator, the Dr said he’s worried that she won’t be able to overcome it.

  6. Robyn Reply

    My mother died from acute lung inflammation approx 5 weeks after commencing this drug treatment. All ICU, oncologists and infectious disease specialists, at no time investigated or had mentioned this FDA warning. We asked numerous times if it could be a drug allergy. 7 days were wasted on endless tests for pneumonia types, even TB. This could have been prevented.

  7. Maureen Reply

    My mom just passed due to side effect of ibrance – severe pnuenomitis. Interested if any lawsuits started out there.

  8. Robyn Reply

    Has anyone in this comment section made contact with each other? It beggars belief that no-one is accountable for a person’s death from ADR to Kisqali.

  9. Chris Reply

    My girlfriend’s grandmother passed in July due to complications from Ibrance. From the time she was prescribed it, it worsened her situation. Has anyone heard of a pending lawsuit, or more cases of Ibrance’s negligence?

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