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Law Offices of Thomas J. Lamb

Actemra: FDA Evaluating Regulatory Action Due To Signs Of Serious Risk

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Actemra is approved by the FDA for the treatment of several different medical conditions:

  1. 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);
  2. Giant Cell Arteritis (GCA) in adult patients;
  3. Polyarticular Juvenile Idiopathic Arthritis (PJIA) in patients 2 years of age and older; and,
  4. 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.

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No Warning Added By FDA To Drug Label For Actemra About Pancreatitis

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An insightful article by reported Charles Piller, “Failure to warn: Hundreds died while taking an arthritis drug, but nobody alerted patients”, published June 5, 2017 online by STAT, put the spotlight on some serious but little-known side effects associated with this medicine from Genentech, Inc.

From that recent article we get this rather alarming safety information about Actemra:

… STAT analyzed more than 500,000 side-effect reports on rheumatoid arthritis drugs, and found clear evidence that the risks of heart attacks, strokes, heart failure, and other conditions were as high or higher for Actemra patients than for patients taking some competing drugs.

Most of those medications warn about these risks on their labels. Actemra does not.

Consumers are barraged every day with drug ads accompanied by numbing lists of side effects, but STAT’s investigation shows that the risks to patients might be greater than they are led to believe. The Food and Drug Administration has received reports on 1,128 people who died after taking Actemra, and has reviewed its safety several times since it was approved. But the agency doesn’t have sophisticated tools to determine whether the drug was a culprit or a bystander in those deaths….

Experts who examined the data at STAT’s request said the FDA should immediately consider warnings for heart failure and pancreatitis — an inflammation of the pancreas that in its acute form can kill up to 50 percent of patients. They said the evidence that Actemra might increase the risk of heart attacks, strokes, and interstitial lung disease, a sometimes-fatal scarring of lung tissue, is less convincing but warrants further review.

This focus on Actemra side effects and the lack of warnings about these adverse reactions shines the light on the apparent inadequate standards of post-marketing surveillance for drugs approved by the FDA.

We are interested in hearing about patients who were diagnosed with pancreatitis or some other serious side effect while using Actemra. You can do this by submitting a Quick Contact Form or by using the Email link found in the sidebar.

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Multiple Myeloma Drug Pomalyst Associated With Side Effects Risks Of Cardiac Failure, Interstitial Lung Disease, And Hepatotoxicity

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In May 2015 The Medicines and Healthcare Products Regulatory Agency In UK Issued A Drug Safety Update; Will There Be Similar FDA Action?

 
SUMMARY: Pomalidomide (brand name: Pomalyst in the US; Imnovid in Europe) is a multiple myeloma drug.

On May 20, 2015 Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom issued this Drug Safety Update, “Pomalidomide: risks of cardiac failure, interstitial lung disease and hepatotoxicity”, which stated:

A review by the MHRA and other EU medicines regulators concluded that [Pomalyst (pomalidomide)] can cause interstitial lung disease (ILD), cardiac failure and hepatotoxicity. This conclusion was based on data from clinical trials, reports from clinical practice and published case reports.

This May 2015 MHRA Drug Safety Update included this additional information about each of these Pomalyst side effects:

Cardiac failure

… In most cases, this side effect occurred in patients with cardiac disease or cardiac risk factors and within 6 months of starting [Pomalyst (pomalidomide)]….

Interstitial lung disease

… Onset of respiratory symptoms is usually within 6 months of starting treatment. However, there have been cases where ILD occurred approximately 18 months after starting [Pomalyst (pomalidomide)]….

Hepatotoxicity

… The risk of serious hepatic events appears to be highest in the first 6 months of treatment, therefore regular liver function monitoring is recommended during this period….

We will continue to monitor the safety profile of Pomalyst (pomalidomide) including watching for any similar side effects warnings by the FDA.

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Multaq: Increased Risks Of Side Effects, Including Death, Outweigh Any Benefits Say Researchers Who Reviewed Clinical Data

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In Addition, They Are Highly Critical Of Relationship The Sanofi Aventis Drug Company Had With Those Doctors Who Developed Prescribing Guidelines

 
SUMMARY: The importance and significance of a February 2014 JAMA Internal Medicine article about Multaq is presented well by this report, “Dronedarone and Clinical Guidelines: A Dark Chapter That Must Be Reread”, that was published on the Medscape website.

From that Medscape piece by reporter John Mandrola:

The story of how a marginally effective and perhaps even hazardous drug made it to first-line status of major guideline documents is a hard image to revisit. Also difficult to look back at were the lavish steakhouse dinners, the webinars, the “sponsored” programs, and then the result: legions of general cardiologists and primary-care doctors prescribing [Multaq (dronedarone)] en masse. With [Multaq (dronedarone)], for a time at least, hype trounced science…. [emphasis added]

We know, now, since being approved by the FDA in 2009 and soon becoming an often-prescribed atrial fibrillation drug, Multaq has been associated with increased risks of serious side effects, including liver failure, interstitial lung disease (ILD), stroke, and sudden cardiac death.

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Learn more on our Multaq Information Page

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Law Offices of Thomas J. Lamb, P.A.
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Wilmington, North Carolina 28403
910-256-2971 | 800-426-9535
TJL@LambLawOffice.com