FDA Watch List Includes Actemra: Evaluating Regulatory Action Based On Possible Signs Of Serious Risk, New Safety Information
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.
These pulmonary or lung conditions are listed under the heading "Potential Signal of a Serious Risk/New Safety Information" for Actemra on this FDA Watch List. Put otherwise, these pulmonary or lung conditions may be Actemra side effects.
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As background, 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.
We first wrote about Actemra back in June 2017 as regards another possible Actemra side effect: "Despite The High Number Of Actemra - Pancreatitis Cases Reported To FDA, No Warning Added To Drug Label".
We will continue to monitor the FDA for any regulatory action concerning Actemra regarding pulmonary hypertension, interstitial lung disease, and pulmonary alveolar proteinosis, as well as pancreatitis.
Of course, if you have any experiences or observations relevant to Actemra which you would like to share, you can post a Comment below or you can email me.
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