Side Effects of Breast Cancer Drugs Ibrance, Kisqali, Verzenio May Cause Lung Inflammation: FDA
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.
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Learn MoreAccording 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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18 Comments
LaDonnaFebruary 29, 2024 at 12:01 am
A follow up to my previous comment, my mom passed away in September 2020 due to taking this horrific drug. When she started taking Verzenio there was no warning of the lung side effects.
ConnieJuly 14, 2022 at 12:31 pm
My mom passed away on Sept. 2019 after taking Ibrance for only 3 months. She declined so quickly after starting the treatment. They drained about a gallon of fluid from her lungs but then it was too late. Something needs to be done to stop the distribution of this fatal drug.
JamieJanuary 5, 2022 at 10:07 am
My mother passed away in August 2019 from liver failure and ILD after being on Verzenio for almost a year. These side effects (especially ILD) were not released by the drug manufacturer until after her passing. I would also like to know if there is a class action against these drug manufacturers. My mother suffered respiratory, liver and later renal failure due to this drug and it was unfair!!
MicddhaelDecember 5, 2021 at 1:33 am
My mom was put on ibrance in 2017. She beat breast cancer 8 years prior and they said she had some spots on her liver so they prescribed her ibrances. Inflammation of lungs wasn’t a side affect. She passed later that year. I heard on the radio now inflammation is and can cause death. Killed us watching her trying to breath. Would have stayed away if we knew.
DavidSeptember 24, 2021 at 8:56 pm
My wife hasbeen coughing and breathing problems for six months. Her doctor just told us it was probably from the Ibrance. Come on it took this long after going to countless doctors to put two and two together.
DonSeptember 21, 2021 at 12:22 pm
My mom suffered from this medication as well, let’s all find get together and find a firm who will help us
BrookeAugust 20, 2021 at 4:10 pm
My husband died as a result of taking Ibrance. His oncologist kept him on it for 10 months with zero monitoring. I called him repeatedly and reported to him all the side effects my husband was experiencing. His doctor would not help us at all. His passing was absolutely horrific he suffered so much. If there is a class action lawsuit PLEASE let me know.
BrookeMay 14, 2020 at 3:54 am
My husband just passed away from the side effects of Ibrance he first suffered from a saddle pulmonary embolism in January and then he got a severe lung infection 2 weeks ago. He was life flighted to the hospital and everything was done to save him but it was too late. The ICU pulmonary specialist told me it was due to him taking Ibrance. Please if anyone can tell me if there is a lawsuit I would [Show More]My husband just passed away from the side effects of Ibrance he first suffered from a saddle pulmonary embolism in January and then he got a severe lung infection 2 weeks ago. He was life flighted to the hospital and everything was done to save him but it was too late. The ICU pulmonary specialist told me it was due to him taking Ibrance. Please if anyone can tell me if there is a lawsuit I would like to know. I have four young daughters who have lost their Dad.
NickApril 6, 2020 at 5:30 pm
My wife was on it for about a year and half. Starting in july of 2019 she begun to have breathing issues. Every month got worse she complained to doctor said it was since issues. Still had breathing begun to get pnumitis in October got bad in November they took her off in December. She then started zaloda. The damage was already done on February 5th 2020 she passed away from respiratory failure n[Show More]My wife was on it for about a year and half. Starting in july of 2019 she begun to have breathing issues. Every month got worse she complained to doctor said it was since issues. Still had breathing begun to get pnumitis in October got bad in November they took her off in December. She then started zaloda. The damage was already done on February 5th 2020 she passed away from respiratory failure not the cancer she was afraid of dying from but the medicine that was to help her. She had a pulmonary embolism witch is a rare side effect. Be careful and good luck to the women that is suffering from cancer.
ChrisFebruary 8, 2020 at 11:45 pm
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?
RobynFebruary 5, 2020 at 9:06 am
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.
MaureenJanuary 3, 2020 at 9:37 pm
My mom just passed due to side effect of ibrance - severe pnuenomitis. Interested if any lawsuits started out there.
RobynDecember 9, 2019 at 10:57 am
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.
LadonnaDecember 7, 2019 at 2:19 am
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.
CarrieNovember 28, 2019 at 11:29 pm
I have also suffered from the debilitating side affects of the drug Ibrance !
WilliamOctober 15, 2019 at 12:15 pm
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.
wasifOctober 14, 2019 at 5:46 am
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
PamelaSeptember 17, 2019 at 4:06 pm
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.