If you still have any doubts that FDA approval of a drug is basically meaningless, the RA med Actemra should be enough to convince you.
Despite numerous red flags before it was first OK’d seven years ago, and despite hundreds of deaths and injuries that have since resulted, not only is Actemra still selling like hotcakes, but the feds are still telling doctors it’s safer than other RA drugs.
Now, a new investigation into this med has revealed some of the deadly secrets about how the FDA operates.
It’s obvious that once a drugmaker gets its med in the door, only under extremely rare circumstances will the FDA ever look back and see if that drug is harming more than it’s helping.
And that will make you think a lot more than twice before you believe “FDA approved” has any meaning at all.
Alicia Airs was sold on taking an infusion of Actemra for RA when her rheumatologist assured her the med had very few side effects.
But right away, the 40-year-old Ohio woman started having heart palpitations that were so worrisome, she went back to the doctor for help.
He said he had never heard about such a reaction to the drug — and neither had her GP, who suggested she take an antidepressant since she was so “anxious.”
And there’s a very good reason her doctors didn’t know about those heart reactions — and why numerous other patients who have suffered from memory lapses, brain fog, hair loss, pancreatitis, and a long list of other side effects have gotten similar responses.
It seems that even though thousands of adverse event reports have been flooding into the FDA over this drug, the agency is still sitting on its hands when it comes to issuing any new warnings — or even requiring the drugmaker Genentech (part of the pharma giant Roche) to add any of these dangers to Actemra’s label.
A just-out investigation by STAT News uncovered that as of 2012 (only two years after the drug hit the market!), over 3,500 reports had been sent into the FDA’s adverse event reporting system, called FAERS — including 118 deaths, with over 40 of those due to cardiac problems.
But because only drugmakers are actually required to report to FAERS (which for doctors and patients is entirely voluntary), the real numbers of actual adverse events are much higher.
The bad news about Actemra, however, doesn’t stop there.
An FDA review that used FAERS as well as original trial data also found over 250 cases of pancreatitis (which proves deadly for around half of those who come down with it) and 185 instances of interstitial lung disease (a progressive scarring of the lungs that can eventually require a lung transplant) linked to the drug.
STAT took the data it uncovered to several experts, who all agreed the agency should “immediately” issue warnings for heart failure and pancreatitis.
And since both competing prescription meds for RA, Humira and Remicade, carry warnings about heart attacks and heart failure, you can imagine how many extra millions Actemra brings in by being sold as the “safer” drug.
But isn’t there any FDA oversight after the agency signs off on a med?
As Dr. Caleb Alexander from Johns Hopkins explains it, “once a drug has been approved,” the FDA’s clout over that medication is “infinitely smaller.” And there’s no other watchdog agency looking out for us, either.
While the FDA hasn’t lifted a finger to tell patients about these potential dangers of Actemra, you can’t say it hasn’t done anything where the drug is concerned.
At the end of last month, it gifted Genetech with another FDA-approved use for the med — a fast-track OK for patients who suffer from an autoimmune disease called vasculitis (an inflammation of blood vessels).
And that’s apparently how our drug-approval system was designed to work, with the financial interests of Big Pharma as its number-one priority.
But for the untold numbers of patients who’ve been lured into taking Actemra thinking it was somehow safer, only time will tell if they’ll become simply more adverse-event reports for the FDA to ignore.
So if you’re one of them, it’s important that you talk with your doctor right away about getting off of this drug — and not starting up on an equally risky one.
While RA is a painful nut to crack, there are some drug-free approaches that may be able to keep you functioning and off the risky meds entirely.
For example:
- Try cutting down on red meat and adding more fish, nuts, fruits, and veggies to your diet along with lots of extra virgin olive oil — what’s known as a Mediterranean-style diet.
- Give acupuncture a try for relief from pain and inflammation.
- While it may be the last thing you feel like doing, exercising, especially swimming, has been found to significantly improve RA symptoms.
“Failure to warn: Hundreds died while taking an arthritis drug, but nobody alerted patients” Charles Piller, June 5, 2017, STAT, statnews.com
