The U.S. Food and Drug Administration (FDA) recently released an announcement cautioning patients and healthcare providers who use a particular kind of breast cancer medication. These breast cancer medication complications were recently found to include potentially lethal lung inflammation.
Explaining the Breast Cancer Medication Complications
Breast cancer medication complications for Ibrance, Kisqali, and Verzenio were discovered after patients with advanced breast cancer began to experience respiratory distress during treatment. The official list of drugs affected by the breast cancer medication complications was published by the FDA and included:
- Kisqali Femara Co-Pack
These four drugs all belong to a classification of medication known as cyclin-dependent kinase 4/6 inhibitor medicines (CDK 4/6 inhibitors).
CDK 4/6 inhibitors are a class of medications that are often used in tandem with hormone therapy and other treatments to address hormone receptor-positive, human epidermal growth factor 2-negative metastatic breast cancer that is advanced, or spread to other parts of the body. CDK 4/6 inhibitors are designed to block molecules that promote the growth of cancerous cells. The CDK 4/6 inhibitors singled out by the FDA have been in use for between two and four years and have had a generally positive effect on improving the lives of patients.
When CDK 4/6 medications work, patients are placed in a state of “progression-free survival” in which their cancer does not grow substantially, allowing the patient to live more normally. In part because of this success, the FDA has not recalled any products for breast cancer medication complications at this time. In their statement, it is made clear that the FDA believes that “the benefits of taking these medicines outweigh these risks” and they have stated repeatedly that although the lung inflammation is potentially lethal, it is also very rare.
In order to control the effects of the new breast cancer medication complications without recalling these valuable medicines, the FDA has taken several steps to safeguard consumers and patients. The FDA has created new mandatory information labels on Patient Package inserts for all CKD 4/6 inhibitors and issued guidelines for patients and health care providers.
Patients are advised to look out for any new or deteriorating symptoms that may indicate that respiratory irritation is occurring. Chiefly, the FDA is asking patients to talk to their health care professional if they experience difficulty or discomfort while breathing or unusual shortness of breath without any increase in physical activity.
Health care professionals have also been given instruction to minimize the risks of breast cancer medication complications. The FDA has requested that patients be monitored for and respiratory issues that could indicate the presence of interstitial lung disease (ILD) or pneumonitis. Health care professionals have been especially cautioned to look for patients who present with the following symptoms:
Health care professionals have also been warned that interstitial infiltrates that appear in radiologic exams for patients that have had infectious, neoplastic, and other causes excluded may also be in respiratory danger. As a final caution, the FDA has advocated permanently discontinuing treatment in patients with severe ILD and/or pneumonitis.
How the Breast Cancer Medication Complications Affect Your Compensation
The FDA is taking all the steps that they can to control the future incidences of lung inflammation, but for many, this warning has come after they have already suffered high levels of pain and possibly even died. If you or a loved one have experienced lung inflammation that has led to pain, medical complications, or wrongful death while taking Ibrance, Kisqali, or Verzenio, financial compensation may be available to you. To pursue that compensation will require the very best in legal representation. For the best in legal representation, choose Parker Waichman LLP.
At Parker Waichman LLP, teams of experienced trial attorneys are prepared to pursue your case to its utmost conclusion in order to secure you the most compensation possible. These attorneys have extensive experience pursuing defective drug cases. Don’t wait to claim what you deserve, contact Parker Waichman today.