The U.S. Food and Drug Administration has issued a safety alert indicating three drugs used to treat some patients with advanced breast cancer may cause severe lung inflammation. According to news reports, all three therapies – palbociclib (Ibrance, Pfizer), ribociclib (Kisqali, Novartis) and abemaciclib (Verzenio, Eli Lilly) – are cyclin dependent kinase 4/6 inhibitors. The federal agency approved adding warnings to prescribing information and patient package insert for the entire class of CDK 4/6 inhibitors.
These types of drugs are used in combination with hormone therapies to treat adults who have hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. The FDA gave its approval to these drugs in 2015 and 2017 respectively. The agency is urging patients who are using these drugs to notify their health care providers immediately if they experience new symptoms or symptoms that are getting worse involving their lungs. Some of the symptoms to watch out for include difficulty in breathing, shortness of breath while resting or during low activity.
The alert also cautions patients not to stop taking these medications without consulting a health care professional. Doctors and healthcare providers are urged to monitor patients for pulmonary symptoms that may indicate interstitial lung disease or pneumonitis. These symptoms include reduced oxygen in blood or hypoxia and cough. Therapy with these drugs should be interrupted for patients who have new or worsening respiratory symptoms, according to the FDA’s alert. Patients and clinicians are encouraged to report side effects related to these therapies through the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Product Liability Issues
Drug companies have a responsibility to properly test the products they put on the market. If the drugs have any side effects, they are required to publicize those side effects and warn consumers about the potential dangers of taking those drugs. However, drug manufacturers often don’t do their due diligence when it comes to testing. They also fail often times when it comes to warning consumers about the dangers that some of these drugs might pose.
If you or a loved one has suffered serious side effects as the result of a dangerous or defective drug, you may be able to seek compensation for damages including medical expenses, lost income, hospitalization, pain and suffering and emotional distress. If you have lost a loved one to a defective drug, you may be able to file a wrongful death lawsuit against the pharmaceutical company. An experienced defective drug lawyer can help you better understand your legal rights and options in such cases.