Product News and Recalls

In the Absence of Safety Warnings, Actemra May Have Killed Hundreds

rheumatoid arthritis drug actemra may be responsible for hundreds of deathsAs horrible as it can be to endure a life with rheumatoid arthritis, the side effects of the drugs most commonly associated with the treatment of the condition are equally, if not more terrible. In an analysis of more than half a million side effect reports from these medications, clear patterns emerged that indicate strong links to heart attacks, strokes, and heart failure.

Actemra was marketed with the promise of avoiding these and other life-threatening complications and, in fact, carried no warnings indicating a risk of any of them. However, the reality of the situation was that patients taking Actemra were either as likely or even more likely to suffer severe side effects than those taking other rheumatoid arthritis medications. Over 1,100 reports have been filed with the Food and Drug Administration that blame Actemra for the death of a patient.

As a result of these reports, the Food and Drug Administration – the agency charged with ensuring the safety of the medications the American public uses to keep itself alive and healthy – took precisely no action. Neither the FDA nor the drug’s manufacturer have moved to put a single letter of warning on Actemra’s packaging indicating that there is a chance that taking this medication could kill you.

The issue highlights a significant problem with the agency’s methods and motivations for carrying out its assigned duties. On the record, the FDA is completely aware of and committed to executing its task. While the agency declined to comment specifically about the issues surrounding Actemra, it relayed a generic statement claiming it “continually monitors postmarketing safety of approved drug products and remains committed to informing the public in a timely manner when [it] identifies safety issues.”

The reality, however, is that its postmarketing monitoring ability is lacking at best, and it has created numerous pathways toward accelerated approval of drugs including, but not limited to, simply buying their way onto the nation’s shelves. When combined with the revolving door of former pharmaceutical executives occupying key seats on FDA panels – a situation that essentially puts these executives in the position of regulating the very market that controls their financial livelihood – a recipe for failure, and perhaps corruption, is concocted that could not possibly be any more perfect.