June 2017 Investigative Article Published By STAT Calls Into Question FDA Oversight After Drugs Are Approved By Agency
Actemra (tocilizumab) 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.
An insightful article by reported Charles Piller, "Failure to warn: Hundreds died while taking an arthritis drug, but nobody alerted patients"(subscription required), 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.
Strictly Confidential, No Obligation.
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.
On this critical issue, we get this commentary from the June 2017 STAT investigative report:
“We’ve done a very good job of making it easier to approve drugs, often based on very preliminary evidence. But we haven’t ramped up the standards of post-marketing surveillance to make sure that what’s been out there for several years is safe and effective,” said Dr. Vinay Prasad, an oncologist and medical ethicist at the Oregon Health and Science University. “The system is broken, and all the financial incentives are lined up to keep it broken.”...
When this STAT article takes a closer look at how the FDA has handled the apparent safety signal for pancreatitis, which is a potentially life-threatening medical condition, what is reported is rather alarming:
[In 2012], Roche asked the FDA to allow wider use of Actemra, for patients who have failed to get relief from only one other type of rheumatoid arthritis drug, rather than two. In its review, the agency found 258 cases of pancreatitis and 185 of interstitial lung disease among Actemra users in clinical trials, FAERS, and epidemiological data, according to a 2012 report.
An FDA clinical expert said that despite uncertainty in the pancreatitis data, a warning should be included on the drug label “given the potential seriousness of the event.” The expert wrote that interstitial lung disease should be monitored closely.
But Genentech convinced the agency not to label for pancreatitis, arguing that the illness, like interstitial lung disease, had occurred at expected rates for rheumatoid arthritis patients. Without providing specifics about the company’s arguments, the FDA report said there wasn’t “sufficient evidence to support causality and include information in the product label at this time.” The agency approved the broader use of Actemra.
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 Comment below or contacting us privately by using the "Email Me" link found in the sidebar.
DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects (All website content by attorney Tom Lamb)
Drug Injury Case Evaluation - Free. Confidential. No Obligation. (Case review done by attorney Tom Lamb)