Will the FDA-approved drug you’re taking today be found too dangerous to take tomorrow?
That’s the frightening surprise a lot of multiple sclerosis patients got last week when the fairly new med Zinbryta, prescribed for relapsing MS, got pulled from the market after reports of brain inflammation could no longer be ignored.
Sure, that injectable came with a long list of side effects, but we’ve all heard that adverse reactions from drugs – no matter how horrific – are as rare as hen’s teeth.
Unfortunately, that’s not exactly true.
And it’s why you should always put any drug you’ve been given under the spotlight and ask four vital questions before you even take the first dose.
Safe today, gone tomorrow
Most doctors dismiss potential side effects from meds as if they were simply pulled from a hat.
I’ve heard physicians say things like, “Don’t worry — they have to put those warnings on the label!”
Well, you can bet that drugmakers have to! I’m sure that there isn’t one shred of scary information on a drug label that got there by accident or because Big Pharma really wanted us to know about liver and kidney damage or deadly rashes or swelling of the throat or cancer or… death.
But having a drug voluntarily withdrawn from pharmacy shelves is still a very big deal, one that would likely happen a whole lot more if the FDA didn’t always err on the side of drugmakers.
The MS med Zinbryta now joins 35 other Rx drugs that were A-OK to take according to the FDA — that is, until they weren’t.
The list includes one called Baycol, a statin put out by Bayer in 1998. Three years later, however, this best-selling med was pulled after dozens of deaths were reported due to a condition called rhabdomyolysis – a deadly breakdown of muscle tissue (something all statins can potentially cause).
The group Public Citizen said at the time that there were hundreds of other Baycol users known to have suffered attacks of rhabdomyolysis, but luckily, they lived to tell about it.
The NSAID Bextra, prescribed for arthritis and other joint pain, lasted for almost three and a half years before the FDA told Pfizer to get it off the market. That drug was linked to side effects involving the heart (such as deadly heart attacks and stroke), stomach (including GI bleeding), and skin (the “boiled alive” drug reaction called Stevens-Johnson syndrome where your skin literally peels off).
But although Bextra is gone, the FDA has allowed a similar Pfizer blockbuster, Celebrex, to keep right on selling.
The Wyeth painkiller Duract only sold for a year before patients started turning up with such severe liver damage they needed transplants – with some never making it that far.
The antibiotic Omniflox barely lasted four months before Abbot hurriedly recalled it because of blood cell disorders, kidney failure, and life-threatening breathing reactions.
Sometimes, however, a drug can cut a path of horror for decades before regulators act. That was the case with the opioid drugs Darvon and Darvocet, which were prescribed for over half a century before the FDA finally figured out that thousands had died from resulting heart problems.
So yes, those warnings that you hear on the TV commercials and see on the Rx bottles are very real. And they shouldn’t be thought of as just some remote possibilities that drugmakers put down because their lawyers make them.
And that’s why you need to ask these four important questions of your doctor before you start up on any med:
#1 Is there a safer alternative?
#2 What might happen if I don’t take this medication?
#3 Is this drug being prescribed “off-label” (in other words, not for the condition the FDA approved it for)? If so, what was it was meant to treat? (You don’t want to take a cancer med for acne, for example.)
#4 Do I really need an Rx for my problem?
Even if you’ve known your doctor for years and trust him completely, these are still important things to find out. And I’m sure that untold numbers of patients (or their survivors) wish that they had asked.
“MS drug daclizumab pulled from worldwide market” Judy George, March 2, 2018, Medpage Today, medpagetoday.com