FDA Issues New Warnings On Statin Drugs

Federal health officials have added new safety alerts to statins, a class of drugs used to lower cholesterol levels. The Food and Drug Administration cited rare side effects, including memory loss, diabetes and muscle pain. Robert Siegel talks to Rob Stein about the news.

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ROBERT SIEGEL, HOST:

The Food and Drug Administration has issued new safety warnings about a popular class of drugs used to control cholesterol levels. The FDA says the drugs, known as statins, can cause several side effects, including cognitive problems such as memory lapses and confusion. But the agency is stressing that the side effects appear to be rare and not serious. NPR's Rob Stein joins us now to discuss the new warnings. And, Rob, the drugs we're talking about here - statins - are used by millions of Americans. I want you to remind us what statins are exactly and what they do.

ROB STEIN, BYLINE: Right, Robert. Statins, as you mentioned, are one of the most commonly used drugs in the United States. In fact, more than 20 million Americans take them. And the one people probably have heard about the most is called Lipitor. It's been on the market for a long time and it's been one of the top selling - if not the top selling - prescription drug on the market for years.

And what they do is they lower a form of cholesterol that's called bad cholesterol. It's LDL cholesterol and high levels of this type of cholesterol can increase the risk for heart attacks and strokes.

SIEGEL: And tell us more about the problems that the FDA is now warning might occur with these drugs.

STEIN: There are really two side effects that they're highlighting in this latest round of warnings. One are cognitive problems. These are problems with memory, forgetfulness, some confusion. And the FDA has been hearing about these problems for years and they just decided to take another look at it and decided they'd had enough reports that it's worth sort of adding it to the list of warnings on the labels of these drugs.

SIEGEL: Well, what should somebody do if they're taking a statin and they discover that something, you know, forgetting how to balance their checkbook has occurred?

STEIN: Right, right. Yeah. That's one of the problems that I've heard people have reported about this. Some people it's been so serious they've actually lost their jobs. For most people, it's been fairly minor, just sort of the everyday forgetfulness, where did I leave my keys sort of a thing, kind of a fuzzy-headed feeling.

And what the FDA is saying, it's really important that people not just stop taking their statin. That's really important. They should go talk to their doctor and ask them what they should do and what they might try doing is just discontinuing a statin for a while because the side effects seem to go away after a few weeks, they might start switching them to a different statin or they might try recommending diet and exercise if that might be appropriate.

SIEGEL: The FDA is also alerting people to other possible problems with statins related to blood sugar levels. What is the concern about there?

STEIN: Yeah. There seems to be a fairly consistent signal showing up in a lot of the studios showing that people who are on statins do experience a very small increase in blood sugar levels and can actually have an increased risk for diabetes. Now this, of course, is a concern because diabetes is a major cause of heart problems and heart disease, so it's sort of defeating the purpose of taking a statin.

But, again, it appears to be fairly rare and the increases fairly low and it's just something that doctors and patients should be sort of aware of and keep an eye on.

SIEGEL: So, Rob, what's happened here is the Food and Drug Administration has said these are big enough problems with statins that we feel we should tell the country about it, but at the same time, we think that these risks do not outweigh the benefits that we see in taking these drugs.

STEIN: Right. And the thinking there is that, while there are these risks, the risks are very low and are fairly rare and tend to be not serious or cause serious health problems in most cases, whereas the benefits of statins have been demonstrated very clearly for many years. They can significantly decrease the risk for heart attacks and strokes and that's the leading cause of death in the United States.

So the benefits, the reduced risks for heart attacks and heart disease seem to outweigh the risks that are caused by the drugs, and especially for people who have already had a heart attack or a stroke or already have been diagnosed with heart disease.

SIEGEL: Put me in the FDA's seat here for a second. What's gained by my telling people, it's not that serious but we think some memory loss, some confusion might be caused by taking this drug, which we think, on balance, is very helpful?

STEIN: What they're really trying to do here is they're just trying to make people aware of the possibility of these problems. The FDA's been trying a lot harder lately to be more transparent and to make people aware of possible risks earlier than they had been because they've come under some criticism in the past for not doing that quickly enough.

And, again, these by no means are considered serious side effects, but it's just something that people should know about and be aware of and keep in the back of their minds.

SIEGEL: OK. Thanks, Rob.

STEIN: Well, thanks for having me.

SIEGEL: That's NPR's Rob Stein speaking with us about the new FDA safety warnings about the drugs known as statins.

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