Attention aspirin, ibuprofen, naproxen, ketoprofen, and all you other painkillers out there: You are about to face the closest scrutiny ever — from the consumers who buy you. That’s right — a change is on the horizon for painkillers, and it’s not going to be pretty.
It’s not about whether these drugs work or not; that’s assured because we know they do. Instead, the focus is on the risk of side effects from these common medications — effects that strike your digestive system and internal organs. In a new proposal by the Food and Drug Administration (FDA), many of the world’s most popular pain relievers will come with impossible-to-miss labels.
These labels will highlight the warnings that most of us likely ignore: that if you overuse these seemingly safe drugs, you face a risk of liver failure (acetaminophen) and intestinal bleeding (a handful of others), for example.
The FDA acknowledges that these drugs are safe, a fact proven through the decades, as millions of Americans use them every day. But the number of people who understand the adverse effects is not high. When millions of people use a handful of drugs, what are generally rare side effects become a little less rare.
This fact has been echoed in concerns voiced by family doctors, who sometimes see overdoses of acetaminophen, which is one of the biggest causes of sudden liver failure. About 200 million people in the U.S. take these kinds of products each year.
Although the statistics are very small in comparison with that number, it happens hundreds of times a year: people unwittingly pop too many pills, too often, or combine them with other medications that might also include the same ingredient. This happens when a drug becomes commonplace, when it becomes an afterthought to pop a painkiller to get rid of a headache or help you sleep.
The proposal says that any over-the-counter product containing acetaminophen would have to trumpet that fact on the display package and actual plastic bottle. They will include a highlighted warning describing how an overdose can cause liver failure, for example, and caution against mixing it with alcohol.
Then there are non-steroidal anti-inflammatory drugs (NSAIDs) — basically all painkillers that don’t contain acetaminophen fall into this category. For every 100,000 users, 15 people die of gastrointestinal bleeding due to NSAIDs. Those who need to be careful with these drugs include anyone over 60, those with ulcers and/or stomach bleeding, those who’ve had more than three drinks a day, or anyone taking blood thinners or steroid medications.
The proposed package changes will help alert consumers to the possible side effects if these drugs are overused. For people with chronic pain, popping one or two a day is unlikely to be the ideal course of action.