The FDA finally admits it doesn’t know the real risks of taking newly approved drugs

In a move that has nothing to do with the AHA guidelines, the FDA has egg all over its face.

That’s because a new data tracking system has forced it to admit that new drugs could be putting us in danger.

This comes after decades of assuring us that approved drugs are “safe and effective” and it has “scrutinized everything” about a new drug to make sure it’s okay to take.

Admitting that sometimes “adverse events” show up only after “a medical product is on the market and many more people use it,” the acting director of the FDA’s Division of Epidemiology is letting the cat out of the bag.

This new tracking system called “Sentinel,” will search medical records for evidence “that certain products are linked to specific adverse effects.”

Those clinical trials the FDA has been relying on only represent a fraction of potential users, they are now conceding.

And let’s remember…the drug company chooses the users for the trials. That means they aren’t necessarily a good cross-section of the people that will actually take it. So possible side effects and complications don’t always show up before a drug hits the market and gets dispensed to millions.

Keep in mind, Sentinel doesn’t really change anything. The first patients to be put on a newly approved drug will still be guinea pigs.

Only now, the FDA might do a better job of tracking them.

Resources

“Sentinel: harnessing the power of databases to evaluate medical products” Michael D. Nguyen, MD, March 18, 2014, FDAVoice, blogs.fda.gov