Actemra is approved by the FDA for the treatment of several different medical conditions:
- Moderately to severely active rheumatoid arthritis in adult patients who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs);
- Giant Cell Arteritis (GCA) in adult patients;
- Polyarticular Juvenile Idiopathic Arthritis (PJIA) in patients 2 years of age and older; and,
- Systemic Juvenile Idiopathic Arthritis (SJIA) in patients 2 years of age and older.
The responsible drug company is Genentech, Inc.
In July 2018 the FDA issued this document, “Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS): January – March 2018”, which is sometimes generally referred to as the “FDA Watch List”.
Included on this July 2018 FDA Watch List is the Actemra (tocilizumab) injection.
In particular, the FDA is evaluating the need for Actemra drug safety regulatory action due to adverse event reports involving these three medical conditions:
- pulmonary hypertension;
- interstitial lung disease; and,
- pulmonary alveolar proteinosis.
We will continue to monitor the FDA for any regulatory action concerning Actemra regarding pulmonary hypertension, interstitial lung disease, and pulmonary alveolar proteinosis.[Read article in full at original source]