Is a drug you’re taking on the FDA’s ‘Serious Risk’ list?

How do you know if a drug you’re taking is being “watched” by the FDA because of serious side effects?

Unless you consult the agency’s official list of “Potential Signals of Serious Risks,” or unofficially, the “Watch List,” you likely won’t. And neither will your doctor.

The Watch List, which gets updated four times a year, is a way for the FDA to do its job while not really doing its job! Slap a med on the market and let the millions of guinea pigs (a.k.a. patients), see what the results might be.

Because while all that “watching” is going on, millions continue to pop these meds, blissfully unaware of what the consequences may be.

What you don’t know can hurt you

When a diet pill called Contrave was approved by the FDA three years ago, we told you how this “new” med was really a combo of two incredibly dangerous old drugs. One was an antidepressant and the other prescribed for people addicted to opioids.

Now, the FDA is “watching” Contrave, as it has been receiving reports of people losing consciousness while taking it. Currently, the agency is “evaluating” if it wants to do something about that — which, if it does, would likely turn out to be a warning in super tiny print on the long label no one ever reads.

Then there’s Northera, a drug for patients who have blood pressure that drops enough shortly after standing up to make them feel lightheaded or dizzy.

Northera was being watched because it appears that it really did its job in raising blood pressure so well that the FDA is warning it can cause you to have a stroke.

And those are just a couple of the examples from the most current quarterly report.

What this really goes to show is that there’s a lot going on behind the scenes with prescription drugs that we never even hear about. We usually only do, in fact, when something gets so bad that the news leaks out and the media pick it up. Or, when a lawsuit is filed that makes someone’s near-death experience a matter of public record.

The list is derived from the “FDA Adverse Event Reporting System,” or FAERS. And that comes from reports submitted to the agency from health professionals, or even just patients.

Actually, anyone can submit a report to FAERS. But here’s the thing — reporting to FAERS (unless you’re a drugmaker) is totally voluntary! If you tell your doctor about a reaction you had to a drug, he doesn’t have to report it to anyone. So, you can imagine that what’s included only represents a fraction of what’s really going on.

Even the FDA admits it receives just 10 percent of serious adverse reactions to drugs. But other experts put the figure as low as 1 percent.

One of the obvious answers to this problem, of course, is to take as few drugs as possible.

Another thing you can do if you must be taking a med is to check out the FDA’s website using this address: www.fda.gov/medwatch. You’ll see plenty of new reports on side effects and even recalls, such as the latest for EpiPen.

And if you’ve had a reaction to a drug, you may want to consider filling out the MedWatch form yourself (using the red button that says “report a problem”). While it might simply be another drop in that 10 percent bucket as far as the FDA is concerned, it’s also the only way other patients might learn about the dangers of a particular med.
“Ten drugs make new FDA watch list” Robert Lowes, April 3, 2017, Medscape, medscape.com