16 September 2019

The US Food and Drug Administration (FDA) has issued a safety announcement about a “rare but severe” lung inflammation that can result from the use of any of 3 breast cancer medications – palbocilcilb (Ibrance), ribociclib (Kisqali), and abemaciclib (Verzenio). These 3 medications are in a class of drugs called cyclin-dependent kinase (CDK) 4/6 inhibitors. They are used in estrogen receptor positive (ER+), Her2/neu negative metastatic (Stage 4) breast cancer, and work by interfering with cell division

The FDA announcement states that “the overall benefit of CDK 4/6 inhibitors is still greater than the risks when used as prescribed.” Palbociclib has been FDA-approved since 2015, and ribociclib and abemaciclib hae been approved since 2017. In evaluating studies of all 3 of the CDK 4/6 inhibitors, the FDA alert noted that 1-3% of patients taking these medications developed severe lung inflammation, and less than 1% died due to the condition.

The FDA recommended that patients notify their physicians immediately if they develop difficulty or discomfort with breathing or shortness of breath while at rest or at low activity when taking any of these medications. The FDA alert notes that there no specific risk factors that have been identified to determine how likely an individual patient is to develop severe lung inflammation while taking one of the CDK 4/6 inhibitors. They recommended that physicians routinely monitor their patients for lung symptoms that could indicate the development of severe inflammation. They also recommended that any side effects be reported to the FDA MedWatch Program. The alert noted that common side effects include “nausea, vomiting, diarrhea, constipation, decreased appetite, abdominal pain, infections, low red blood cell counts, low white blood cell counts, low platelet count, headache, dizziness, hair thinning or loss, rash, tiredness, and weakness”. I will post an update as more information becomes available.

Additional Information:

26 February 2019

The US Food and Drug Administration (FDA) has issued a safety communication regarding the use of breast thermography as a sole means of breast cancer screening or diagnosis.

Thermography has been around for many years, and as seen by the FDA communication, has been the subject of multiple warning letters. Thermography works by detecting patters of heat flow on or just below the body surface. We know that breast (and other cancers) tend to have a more robust blood supply compared to normal tissue – and proponents of thermography feel that this reliably translates into detectable changes in heat patterns.

Thermography does not utilize radiation and there is no compression of the breast, making it appear to be an ideal alternative to mammography. Unfortunately, it has never been shown to reliably detect breast cancer, even in patients with suspicious mammography findings (see Collette, AE et al. paper referenced below).

The FDA alert notes that thermography was never approved as a stand alone test to screen for breast cancer, even though many facilities advertise it as an alternative to mammography and other imaging. Thermography practitioners also claim that precancerous changes can be detected many years prior to the development of cancer. I’ve seen many patients over the years who have had abnormal thermograms – and they leave the facility with recommendations including hormone creams (to apply to the breast), lymphatic massage, and repeat thermography in 3 months. Some of these patients in fact had large, advanced cancers. Thermography is not covered by insurance, and costs can range anywhere from $150 – 500 / session. While every thermogram report I’ve seen includes a recommendation for additional imaging with mammogram, ultrasound or MRI (usually in the fine print), this is never really discussed with the patient.

Mammograms have their flaws and early detection does not necessarily result in cure. However, thermography is not the answer.

Collette AE et al. 2014: Infrared Imaging does not Predict the Presence of Malignancy in Patients with Suspicious Radiologic Breast Abnormalities

GMA – Breast Cancer Survivor Shares Cautionary Tale