FDA Issues Warning About Ibrance, Kisqali, Verzenio

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Breast Cancer Drugs Linked to Severe Lung Inflammation

The U.S. Food and Drug Administration (FDA) is warning breast cancer patients about a rare but serious side effect of certain cancer drugs. Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib) have been linked to severe lung inflammation in some patients. 

If you are being treated for breast cancer with either Ibrance, Kisqali, or Verzenio and developed severe lung inflammation, you may be entitled to financial compensation. The attorneys at Schmidt National Law Group are investigating possible lawsuits against the manufacturers of these powerful drugs. 

Call us at 800-631-5656 today to speak with a member of our legal team. We can help answer your questions and see if you qualify for a possible lawsuit against the manufacturers. 

FDA Warning

The FDA issued a safety communication on Sept. 13, 2019 warning consumers and healthcare professionals about the possible risks of Ibrance, Kisqali, and Verzenio. All three belong to a class of drugs called CDK 4/6 inhibitors and are used in combination with hormone therapies to treat adults with advanced stages of certain breast cancers. 

These CDK 4/6 inhibitors are relatively new to the market. Ibrance was approved by the FDA in 2015 and Kisqali and Verzenio were both approved in 2017. The drugs were approved to treat adults with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative advanced or metastatic breast cancer that has spread to other parts of the body. 

The drugs have been shown to improve what’s called progression-free survival—the amount of time after the start of treatment the cancer does not grow and the patient is alive.

Symptoms of Lung Inflammation

The agency is recommending that patients contact their doctors as soon as possible if they experience new or worsening symptoms involving their lungs. These symptoms may indicate a rare but life-threatening condition that can lead to death. 

Symptoms of lung inflammation include:

  • Difficulty or discomfort breathing
  • Shortness of breath while at rest or with low activity 

What Your Doctor Will Look For

Your doctor should monitor you regularly for symptoms of lung inflammation, including for pulmonary symptoms that might indicate interstitial lung disease (ILD) or pneumonia. Signs and symptoms of these conditions include:

  • Hypoxia
  • Cough
  • Shortness of breath
  • Signs of interstitial lung disease on certain radiologic exams

Doctors should report adverse events or side effects of Ibrance, Kisqali, and Verzenio to the FDA using the MedWatch Safety Information and Adverse Event Reporting Program. Patients can also report adverse events to the FDA as well using the same reporting system. 

FDA’s Recommendations

The FDA does not recommend patients stop taking Ibrance, Kisqali, or Verzenio before speaking with their doctor. The regulatory agency says the benefits of the medications still outweigh the risks. But if you develop symptoms, talk to your doctor right away. 

Doctors should stop prescribing Ibrance, Kisqali and Verzenio and interrupt treatment in patients who develop new or worsening respiratory symptoms. Doctors should discontinue treatment altogether in patients who have severe ILD or pneumonia. 

Investigating Possible Lawsuits

The lawyers at Schmidt National Law Group are investigating possible lawsuits against the manufacturers of Ibrance (Pfizer), Kisqali (Novartis), and Verzenio (Lilly).

If you are being treated for breast cancer with either Ibrance, Kisqali, or Verzenio and developed severe lung inflammation or other lung injuries, you may be entitled to financial compensation. Call us at 800-631-5656 today to speak with a member of our legal team.