Guideline: FDA issues warning on CDK inhibitors
Contents
At a glance | Questions for your doctor |
Findings | Resources |
STUDY AT A GLANCE
This study is about:
The U.S. Food and Drug Administration’s () safety alert warning that Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib) may cause a rare but severe inflammation of the lungs.
Why is this study important?
The approved Ibrance in 2015, and both Kisqali and Verzenio in 2017 to treat some patients with advanced breast cancer. These drugs, called CDK 4/6 inhibitors have been shown to significantly improve the amount of time a cancer does not grow and the patient is alive. However, in some patients they may cause rare but severe lung inflammation
findings:
CDK 4/6 inhibitors are a class of prescription medicines that are used in combination with hormone therapies to treat adults with hormone receptor-positive, advanced or breast cancer.
The reviewed cases of lung disease associated with use of CDK 4/6 inhibitors. Cases were identified from both ongoing and completed clinical trials. Cases were also identified from the ’s drug safety database.
The found that, although rare, there were serious cases and/or deaths with Ibrance (palbociclib), Verzenio (abemaciclib), and Kisqali (ribociclib).
- Across clinical trials of these three CDK 4/6 inhibitors, 1 to 3 percent of patients had lung inflammation of any grade.
- Less than 1 percent of these patients had fatal outcomes.
- Less than 1 percent of these patients had fatal outcomes.
- Among patients who developed lung inflammation, including fatal cases, there were patients who had no risk factors for lung disease, but some patients had at least one risk factor.
Guidelines
The recommends that anyone taking these CDK inhibitors notify their health care provider if they have any new or worsening symptoms involving their lungs.
Symptoms to watch for include:
- Difficulty or discomfort with breathing
- Shortness of breath while at rest or with low activity
What does this mean for me?
Rarely, CDK 4/6 inhibitors can cause severe lung inflammation. However, the benefits of taking these medicines may outweigh this risk. The is urging patients to not stop taking a CDK 4/6 inhibitors without first talking to their health care provider.
It is important to know:
- All medicines have side effects even when used correctly as prescribed.
- People respond differently to all medicines depending on their health, the diseases they have, genetic factors, other medicines they are taking, and many other factors.
Experts do not yet know the factors that make a patient high-risk for severe lung inflammation when taking Ibrance, Kisqali, or Verzenio.
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Posted 9/24/19
References
warns about rare but severe lung inflammation with Ibrance, Kisqali, and Verzenio for breast cancer. website. Posted September 13, 2019.
Disclosure
FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.
This article is relevant for:
People currently taking a CDK inhibitor
This article is also relevant for:
Men with breast cancer
ER/PR +
People with a genetic mutation linked to cancer risk
Breast cancer survivors
Women under 45
Women over 45
Metastatic cancer
Be part of XRAY:
- Is it safe for me to continue to take my medication (CDK4/6 inhibitors)?
- I am worried I am risk for lung disease, should I continue to take my medication (CDK 4/6 inhibitor)?
- Are there other medications that are as effective for me as a CDK 4/6 inhibitor?
- What signs or symptoms of lung disease should I be looking for?
- Should I have a chest XRAY or other scan for lung disease?
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Updated: 02/15/2023
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