The Food and Drug Administration has strengthened its warnings about painkillers such as ibuprofen and naproxen, saying not simply that they may raise the risk of heart attacks and strokes, but that they do. It’s got people asking questions. Here are answers to some of the most common ones:
How big is the risk from these drugs?
“We don’t know,” says Dr. Steve Nissen, who heads cardiovascular medicine at the Cleveland Clinic. “And I think it’s important to tell the public that.” It’s because the drugs went on the market without large clinical trials that are usually required for prescription medication, so there’s no information on who is most at risk, what the risky dose is or when the risk kicks in. “Their effects on the heart were simply never studied.”
The FDA is basing its warnings on what are called observational studies. These studies looked at large populations of people to see if those who took these drugs over long periods of time — like people with arthritis — had higher rates of heart attacks and stroke. They did. What the studies cannot tell is whether there’s something different about people who voluntarily take such drugs over time, compared to people who don’t, that might put them at risk.
Millions of people have been taking these drugs every year with no ill-effects. “I think the public needs facts, need the truth. They don’t need to be overly alarmed by this,” Nissen said.
Are these drugs safe for kids?
There’s no indication that they are not, but FDA and other experts stress that anyone, especially children, should take all drugs at the lowest possible dose for the shortest period of time. “Don’t give your child any drug unless they really need them,” Nissen said.
What about occasional use?
“From my perspective, I think people can be reasonably assured,” Nissen said. “Here, the principle is don't overdo. Take the dose that’ll get the job done. I occasionally overdo it with exercise or whatever and I will take one of these drugs. I will take it for a day, half a day and not continue it if I don't need it,” he added.
“Certainly if you have acute injury, taking these drugs is a reasonable thing to do.”
Dr. Allen Taylor, chief cardiologist at Georgetown University Medstar Hospital, agrees. “What I tell a patient is that a small dose for a short period of time for a drug like this, really poses very little risk,” he said.“But if you need these drugs for a long periods of time in high doses, that's a time to consult your doctor.”
So which drugs are we talking about?
The drugs are called NSAIDS, non-steroidal anti-inflammatory drugs. They’re in the same class as aspirin, although aspirin does not raise the risk of heart attack and stroke — in fact, it can prevent them. Those that raise the risk include ibuprofen, sold under the brand names Advil, Motrin and Midol; naproxen, sold under the brand name Aleve; and the prescription arthritis drug Celebrex. “It is completely unclear whether any of the drugs are better than the others,” Nissen said.
Is there anything safe that I can take?
This FDA warning is an important reminder that no drug is entirely safe. Taking any drug, even one that's sold over the counter, poses some risk. The point is to balance the risks against the benefits. These drugs can reduce fever — a very important benefit. They reduce swelling and inflammation and they relieve pain. People with severe arthritis and other conditions need them to get through the day.
Tylenol, also known as acetaminophen, doesn’t raise heart risks and helps most people to manage pain. But high doses can permanently damage the liver. All NSAIDS, including aspirin, can cause stomach and intestinal bleeding. But NSAIDS may also lower the risk of some cancers.
Opioids can be addictive and dangerous, and the Centers for Disease Control and Prevention says they should be reserved for people who really need them.
The main advice is to talk to your doctor, especially if you have high blood pressure or other heart disease.