Fact Checked

Even FDA-Approved Drugs Can Have Serious Side Effects

What are the odds that a new drug that makes it through the extensive and time-consuming FDA approval process will still turn out to have a serious side effect that will affect its label or even force the agency to pull its approval entirely? According to a recent study, the chances are one in three.

In a study performed at Yale University, researchers tracked the history of all 222 prescription medications approved by the FDA between 2001 and 2010. 71 of them, just under a third, turned out to have a significant and previously unknown side effect that none of the tests or studies uncovered but which turned up within around four years of the drug’s approval and distribution. Only a few of them had to be pulled off the market, but that’s still a lot of important information that no one managed to find in all the tests and studies a drug has to go through to get approval.

Still, there are some silver linings depending on how you interpret the study. For one thing, the fact that all this information is around and easy to track down means the FDA is doing its job by keeping track of complaints and other facts long after they approve a drug. And as a medical researcher will tell you, a sample size of a few hundred is nothing compared to the general population. A few unknowns have to be expected, and so it’s good the FDA follows up on recently approved medications.

When it comes to which drugs are most likely to have unknown side effects, the study found that the usual suspects are the relatively new ones: psychiatric drugs and biological drugs, drugs whose active ingredients come from living organisms rather than chemical combinations. And to no one’s real surprise, drugs that move through the FDA’s “fast track” to approval fail slightly more often than those that go through the more time-consuming process.

However, one aspect of drugs the study didn’t cover is the growing cost of prescription drugs across the board. To take that into account, you’ll need a USA Rx pharmacy discount card. You’ll find our card accepted at 60,000 pharmacies across the nation, including all the major chains, and all we need from you is your name and an email address. And if you want more information on how you can get up to 75 percent off the sticker price for brand names and generics, let us hear from you by emailing [email protected] or calling 888-277-3911.