Ibuprofen is one of the drugs the FDA warns could increase the risk of heart disease and stroke.

Ibuprofen is one of the drugs the FDA warns could increase the risk of heart disease and stroke.

Many of us assume that if a prescription is not needed for a particular medication, it’s safe to take. But any drug, over the counter or not, can have side effects. Last week, the Food and Drug Administration issued stronger warnings for some common non- prescription pain relief medications, including Advil, Celebrex, Aleve and Motrin IB. These and other anti-inflammatories, even when taken as directed, increase the risk of heart attack and stroke. We look at what you need to know about the risks and benefits of over-the-counter drugs.

Guests

  • Bruce Lambert Director, Center for Communication and Health, Northwestern University
  • Dr Stuart Seides Physician executive director, MedStar Heart & Vascular Institute, Medstar Washington Hospital Center
  • Deborah Pasko Director of medication safety and quality, ASHP (American Society of Health System Pharmacists)

Transcript

  • 10:06:53

    MS. DIANE REHMThanks for joining us. I'm Diane Rehm. Millions of people who rely on anti-inflammatory over-the-counter drugs such as Advil, Celebrex, Aleve and Motrin IB to relieve minor aches and pains, but the FDA says consumers should be better informed of the risks. Here to talk about the FDA's recent warnings related to nonprescription drugs, Dr. Stuart Seides of the Medstar Washington Hospital Center.

  • 10:07:27

    MS. DIANE REHMBy phone, from Philadelphia, Deborah Pasko of ASHP and joining us by phone from a studio at Northwestern University in Chicago, Bruce Lambert of the Center For Communication and Health. I'm sure many of you will have questions. Feel free to join us at 800-433-8850. Send an email to drshow@wamu.org. Follow us on Facebook or send us a tweet. And thank you all for being with us.

  • 10:08:04

    MR. BRUCE LAMBERTThank you.

  • 10:08:06

    REHMIt's good to have you...

  • 10:08:06

    DR. STUART SEIDESThank you very much.

  • 10:08:07

    REHMCertainly.

  • 10:08:07

    MS. DEBORAH PASKOThank you.

  • 10:08:08

    REHMDr. Seides, I'll start with you. Explain this new warning from the FDA and why it's coming now.

  • 10:08:16

    SEIDESSo the FDA is going to require that packaging for these drugs, these NSAID drugs that we're going to be talking about this morning, carry a warning that there is an increased risk of heart attack and stroke in patients who take them.-

  • 10:08:38

    REHMNSAID meaning non steroidal anti-inflammatory drugs.

  • 10:08:43

    SEIDESThat's right. That's right. Non steroidal anti-inflammatory drugs to distinguish them from cortical steroids, things like prednisone and cortisone, that are also anti-inflammatories, but work by entirely different mechanisms.

  • 10:08:58

    REHMBut weren't there already risks that people knew about?

  • 10:09:04

    SEIDESWell, we've known or at least we think we've know about the increased risks of heart attack and stroke with these drugs, I would say, evolving over the last 15 years. And many folks may be familiar with some of the controversy over a part or a portion of this class of drugs that were removed from the market, drugs like Vioxx and Bextra that may be familiar that were pulled by the FDA.

  • 10:09:38

    SEIDESBut this applies to a broader class of these agents, the so-called non-selective, non steroidal anti-inflammatory drugs and so it applies to a huge number of drugs, a huge number of patients potentially and, of course, these drugs are sold over the counter, which also changes the whole paradigm.

  • 10:10:00

    REHMAnd Bruce Lambert, these drugs that are sold over the counter are ones we're all familiar with. Give us an idea.

  • 10:10:12

    LAMBERTRight. So these are familiar, extremely commonly used medicines. They go by the generic names of ibuprofen or naproxen, et cetera, or celecoxib for Celebrex or the brand names that you mentioned at the top of the show. So globally, these are some of the most commonly used drugs in the world. I read an estimate as I was preparing for the show that 30 million people around the world take these drugs each day.

  • 10:10:42

    LAMBERTThere's 100 million prescriptions for them in the United States each year. There's something like $4 billion spent on this category of pain relievers. So they're among the most commonly used drugs in the world and now we know with greater certainty that they cause an increase in the risk of these very serious outcomes of heart attack and stroke.

  • 10:11:03

    REHMNow, do we know that these risks apply even if somebody is perfectly healthy, Bruce Lambert?

  • 10:11:15

    LAMBERTYes. These risks apply to everyone. These drugs increase the risk for everyone who takes them because of the way they work on our bodies. They increase the clotting of our blood. They increase our blood pressure. They harden our arteries so they affect everyone. But the absolute amount of risk, it depends on how much risk you have for heart disease to begin with.

  • 10:11:38

    LAMBERTSo something like a 40-year-old man, maybe one in a thousand 40-year-old men will have a heart attack each year. But for, you know, an 80-year-old man, it'll be 10 in 1,000. So the people who have greater risk of heart disease to begin with are at greater risk from the damage that -- or the increased risk that these drugs cause.

  • 10:11:59

    REHMDeborah Pasko, ASHP formerly the American Society of Health System Pharmacists, I gather FDA is talking about both prescription and nonprescription drugs, but is asking that the labels be changed on these nonprescription drugs.

  • 10:12:28

    PASKOYes, that is correct. They are speaking for both the over-the-counter, as we mentioned, as well as the prescription NSAIDs. And they're asking for the labeling changes across the board so -- to make sure that we have the labeling changing on both prescription and the over-the-counter medication.

  • 10:12:47

    REHMHas consumer awareness about these over-the-counter drugs simply not been sufficient?

  • 10:12:57

    PASKOWell, as we had alluded to, you know, this has been evolving over the past several years. And I think one of the things that -- when patients go into a pharmacy and they can buy something over-the-counter that somewhat gives a false sense of the medication is safe. And for the most part, that has deemed appropriated by the FDA for a medication to move from prescription status into over-the-counter, it needs to meet certain criteria.

  • 10:13:25

    PASKOHowever, the bottom line is, it is a medication and any time that we take medications, it's important for us to understand the risk associated with those medications. And as consumers and as your show is talking about today, we're really trying to get the word out to those patients who may be taking these medications not only on a short term basis, but on a long term basis as well.

  • 10:13:48

    REHMNow, the question becomes, are there any totally safe over-the-counter medications?

  • 10:13:59

    PASKOI think any medication does have some inherent risk. Some are safer than others, obviously, and the FDA does a very good job at assessing those safety profiles when a drug goes through clinical trials and then comes onto market so I wouldn't say there's nothing out there that doesn't have any type of side effect profile, but some, obviously, are safer than others and then, there's also we may know about side effects more from ongoing clinical studies versus studies that haven't been conducted yet.

  • 10:14:33

    REHMSo Dr. Seides, how do we differentiate between, say, the Advil, Celebrex, Aleve and Motrin IB, how do we differentiate those drugs from, say, Tylenol? Should Tylenol be on this list of drugs that the FDA is warning about?

  • 10:14:59

    SEIDESSo Tylenol or acetaminophen is an entirely different agent and I think that when you look at this whole class of drugs, these drugs in the aggregate have three major effects. They are analgesics, that is they relief pain. They -- some of these drugs are antipyretics, that is they relieve fever. And most importantly, they are anti-inflammatories, they reduce the signs and symptoms of inflammation, you know, the redness, the swelling that we associate with certain conditions.

  • 10:15:36

    SEIDESTylenol is an effective analgesic. It does relieve pain. It's a good antipyretic. It reduces fever. It is not much of an anti-inflammatory agent. So Tylenol or acetaminophen sits outside this group of agents and would not be considered an anti-inflammatory drug, per se. So it is safe, vis a vis, heart and vascular disease, but like...

  • 10:16:05

    REHMBut not safe as far as the liver is concerned.

  • 10:16:07

    SEIDESOther things, that's correct. And as Ms. Pasko was saying, all drugs carry some risk with their use and Tylenol is risky if used in excessive doses or used in people who have underlying liver disease.

  • 10:16:27

    REHMAnd that's what I was wondering. It's the dosage that's really important here, is it not?

  • 10:16:35

    SEIDESAlways, always. And the same thing is true with the NSAIDs. And I would go back to something that Bruce said a moment ago, which is that while the studies suggest that there is an increased risk in everyone, the absolute risk and the balance between risk and benefit for the individual patient depends on what your underlying risk is.

  • 10:17:02

    SEIDESAnd so when you, as a patient, and I suspect a lot of folks out there have taken these drugs at one point or another in their lives, one has to balance your personal risk of heart disease and stroke with the indication for the drug. And so on the one hand, if you are at higher risk, if you are a person, for example, who's had a previous heart attack, you should avoid these drugs, particularly if there is an alternative.

  • 10:17:33

    SEIDESSo for mild pain, mild discomfort, you're far better off using acetaminophen or Tylenol. On the other hand if you are a person whose fundamental underlying risk of heart disease is low, you're a young woman, for example, and you have a condition where there's a great deal of discomfort and your functionality depends on taking those drugs, then I think the balance favors it.

  • 10:18:01

    REHMAll right. And we'll take a short break here. Dr. Stuart Seides is at the Medstar Washington Hospital Center. Your calls, your comments when we come back. Stay with us.

  • 10:20:02

    REHMAnd welcome back. We're talking about new warnings from the FDA about certain classes of drugs. The -- most especially, the nonsteroidal anti-inflammatory drugs and those, of course, do include Advil, Celebrex, Aleve and Motrin IB. But here's an email from George in Wilmington, N.C. He says, "I thought aspirin was an anti-inflammatory." Bruce Lambert, why is it not part of this warning?

  • 10:20:48

    LAMBERTRight. So aspirin is also in this category of drugs but receives a certain different treatment because of exactly the way it works inside your body. Aspirin is significantly safer with respect to strokes and heart attacks than these other nonsteroidal anti-inflammatory drugs that we've been talking about. In fact, as many of your listeners know, people take low doses of aspirin actually to reduce the risks of heart attacks. And aspirin also has other benefits. It's been shown to reduce the risks of certain kinds of cancer as well. But like all these drugs that we're discussing, it has well-known risks. And with aspirin, the risks have to do with bleeding, especially stomach bleeding.

  • 10:21:32

    LAMBERTSo for some patients who have a relatively low risk of stomach bleeding, if they talk to their doctor about that and aspirin works to relieve their pain, it's a good option for them. There are millions of Americans who take aspirin -- low doses of aspirin every day to reduce the risk of heart attack. And there's actually an interesting interaction between these low doses of aspirin and these other commonly taken pain medicines. So -- and the FDA talks about this in their new warnings, that if you take nonsteroidal anti-inflammatory drugs like ibuprofen or Aleve, et cetera, they can actually interfere with the protective effects of low-dose aspirin for preventing heart attacks. So people should be aware of that. And perhaps Dr. Seides could comment more on these sorts of issues.

  • 10:22:23

    SEIDESSo that's correct. I think the key there, though, in terms of prevention, protectiveness, is low-dose aspirin. So all of these drugs affect an enzyme. They work by blocking an enzyme called cyclooxygenase or COX. And there are two forms of this enzyme and each of these drugs have a different level of effect on the two forms. And if you want to keep it very simple, what we call COX-1, blocking COX-1, that's good. It prevents blood clotting. Blocking COX-2 isn't good. And aspirin is a COX-1 inhibitor, so it is good at low doses. At low doses, it only affects blood clotting.

  • 10:23:08

    SEIDESBut actually, if you were able to use higher and higher doses, you would have a much more non-selective effect. And, in fact, those of us in the cardiology community recommend that for cardiac prevention that the dose is actually very low so it only affects so-called COX-1.

  • 10:23:29

    REHMI see. Deborah Pasko, we have a Tweet from Aileen in San Antonio. She says, "Ibuprofen is in a pain-relief cream I got in France. Does topical use carry the same risks? Do the effects go away if you stop taking ibuprofen orally?"

  • 10:23:58

    PASKOTopical creams typically have studies conducted with them of the extent of absorption. I cannot comment on the extent of absorption of a topical cream that's available outside the United States but they are usually absorbed to a lesser extent into the blood stream. But, again, to the extent of that, I really cannot comment without some type of formal study or guidance by the FDA around that specific product.

  • 10:24:28

    REHMTell us, Bruce Lambert, how the language on drug labels is going to have to change as a result of the FDA warning.

  • 10:24:42

    LAMBERTWell, it's mostly just a strengthening of existing warnings. So it's -- I think one of the key changes in the language is some of these things will say -- used to say "may cause" and now it's going to say "cause," to underscore that there's more certainty about these drugs causing these increased risks. And then it's just going to reiterate the kinds of warnings we've already been talking about. That is, that the drugs increase the risk of stroke and heart attack. That the risk begins almost immediately, that is, you could observe this increased risk even -- they've looked at a period of just 0 to 14 days and the risk increases almost immediately. That it affects everyone.

  • 10:25:22

    LAMBERTThat it's -- depends on the dose, so the lower the dose you take and the shorter the duration you take it, the safer they are and, conversely, the larger the dose and the longer the duration, the greater your risk. That people who have a higher baseline risk of heart disease -- because they have high blood pressure or diabetes or they smoke or they're older -- they have greater absolute risk of having these bad outcomes. I think one thing that's really important we haven't touched on yet is that these ingredients -- so naproxen, ibuprofen, et cetera, especially in the over-the-counter medicines -- are in many, many other cold and flu medicines. And so people need to look for these ingredients.

  • 10:26:04

    LAMBERTAnd, you know, I'm sure we can put a link on your website, Diane, that lists all of these ingredients. And then consumers need to be sure -- they might say, "Well, I stopped taking Motrin. I stopped taking Aleve." But that ingredient might still be your cold medicine, in your flu medicine, in your allergy medicine. These ingredients are everywhere. And they, you know...

  • 10:26:21

    REHMI think that's such a good point. Dr. Seides, I'm sure you tell your patients about how to be very careful in taking these drugs. But is the problem that people begin to, say, rely on drugs like Advil if they're, say, tennis players and they've got sore elbows and they begin taking them on a regular basis?

  • 10:26:53

    SEIDESAnd I think that's important, Diane. I think the, you know, the occasional use, you know, for sporadic muscular-skeletal program or other problem is -- the excess risk is very, very low. Unfortunately, the options are not that good out there. So the conundrum one has is a person's functionality. So if somebody finds that, for example, they have trouble walking, they have trouble exercising if they don't use these drugs, you have a bit of a catch-22. And I think this sort of once again raises the issue that people have to own their own health in a way, understand their own cardiovascular risk, understand the relative risks and benefits.

  • 10:27:51

    SEIDESNobody is suggesting, I don't think, that NSAIDS shouldn't be used by anybody at any time, even though, as Bruce said, the risk is -- the absolute risk is increased for everybody, even during short use. But I have many patients who require these drugs in order to remain functional. And in those individuals, we counsel using the lowest dose possible and we counsel a level of vigilance around symptoms that may be suspicious for heart disease and stroke. And so those individuals, like all of us, should be attentive to the signs of chest discomfort, short-windedness, a loss of motor power or sensory power, that suggest an event.

  • 10:28:43

    REHMAnd what about Tylenol? Is there more of a danger of overdose, Bruce or Deborah?

  • 10:28:55

    PASKOSo I think with the Tylenol or acetaminophen, again, as our other guests have explained, that it really comes in moderation. So with Tylenol, it's important to recognize how much you're taking, the daily dose of Tylenol, and really not to exceed the maximum dose recommended. And/or, if you're also consuming alcohol on a regular basis with that product as well, that those can have liver-adverse effects. So I think it's, you know, some patients may take one or the other and in some patients they actually may take both for patients who have chronic problems with arthritis but, again, it's -- the dose that you're taking, the time that you're taking and of how long.

  • 10:29:44

    PASKOAnd I think the other important issue is to also mention that some of these patients may have to take them due to allergies related to other drugs or intolerances related to some of the other products.

  • 10:29:56

    REHMSure. And the...

  • 10:29:57

    PASKOSo, you know, just to make sure they speak with their doctor about that.

  • 10:30:00

    REHMAnd, Bruce, what about those who take, say, Advil and Tylenol at the same time because they find that to be an effective pain relief. Are they affecting different systems in the body? And how save or unsafe is that combination?

  • 10:30:25

    LAMBERTRight. So they do affect different systems in the body. They -- the way that they work is slightly different. But they don't -- taking them together doesn't increase the risk of one or the other. They both have their own individual risks so the risk of Tylenol or any product that contains acetaminophen -- and acetaminophen is also in many, many cold and flu and allergy preparations -- is really the risk to your liver, that at high doses it's very toxic to your liver. It can -- those liver problems can even be fatal or can cause you to need a liver transplant. So it's a very serious thing to be aware of Tylenol overdose or acetaminophen overdose. And now we have this risk with ibuprofen and these other similar drugs.

  • 10:31:08

    LAMBERTBut taking them together doesn't increase the risk of either one.

  • 10:31:10

    REHMHmm.

  • 10:31:10

    LAMBERTYou just are taking on two separate risks -- the liver risk with Tylenol and the cardiovascular risk with ibuprofen. And there's one risk we haven't talked about yet, which was actually the original risk that people were concerned about with these nonsteroidal anti-inflammatory drugs like Aleve or Motrin, and that is the risk of stomach bleeding. So all of these drugs, including aspirin, but not including Tylenol, significantly increase the risk of stomach bleeding. The one with the least risk of stomach bleeding is Celebrex, the prescription drug. All the others -- even including Celebrex, but to a lesser extent -- increase the risk of stomach bleeding. And people can die of this stomach bleeding too.

  • 10:31:49

    LAMBERTSo the message here is that these are powerful drugs. For many years, these drugs were only available by prescription.

  • 10:31:55

    REHMHmm.

  • 10:31:56

    LAMBERTThe risks are very significant. And there's no free lunch. If you're -- there's no drug without risks and the risks are serious. If you're getting tremendous benefit from these medicines, as Dr. Seides said, they may be worth the risk. But if your pain is mild or moderate, there are lots of non-drug alternatives that could be considered, including hot and cold, exercise, distraction, counter-irritation, meditation, massage, et cetera.

  • 10:32:18

    REHMAnd that's something -- that's something I want to ask Deborah about because I gather one big problem is people mixing a drug that's safe, by itself, with, say, a homeopathic drug.

  • 10:32:37

    PASKOThat's absolutely right, Diane. So we have many patients who are on multiple prescription medications or maybe multiple over-the-counter medications. And it's very important for them to speak with their provider or speak with their pharmacist about multiple medications they may be taking. Because, as you said, the drug by itself may be completely safe but once you mix it with another prescription or over-the-counter medication, then you have problems or you may have increased risk for side-effects.

  • 10:33:08

    PASKOAs we talked about that these drugs do carry a risk of bleeding and for patients who take blood thinners, that may have, you know, conditions such as AFib or atrial fibrillation or others, that are on blood thinners in combination with these drugs, they really want to make sure they're having a good conversation with their pharmacist or their provider about the risks associated and if they should be taking those medications together.

  • 10:33:34

    REHMAnd you're listening to "The Diane Rehm Show." And we have a Tweet from Lisa, who says, "What about infants and children? I use this often for teething pain and fevers. What is recommended now?" Dr. Seides.

  • 10:33:56

    SEIDESWell, I'm not a pediatrician, so I really can't answer that question directly. Obviously, the risk -- this particular risk of heart attack and stroke is so low in infants and children, that in and of itself would be a non-issue.

  • 10:34:15

    REHMHow about you, Deborah? Can you respond?

  • 10:34:19

    PASKOI can. So I spent many years as a clinical pharmacist in a pediatric hospital and we gave these medications frequently to pediatric patients and we will continue to do that. There have no studies at this point that have been -- indicated there is a problem in children related to these cardiovascular effects. However, I would say, in children just like adults, there is an increased risk of bleeding that you do have to be careful of. However, normal, healthy children are not usually at risk for those type of conditions. We worry more about those that would have chronic health problems that may need to take Tylenol or ibuprofen for other reasons.

  • 10:35:01

    REHMAnd what about cough and cold medicines for children or for pregnant women, Deborah?

  • 10:35:09

    PASKOSo the cough and cold medications, the -- you know, for children -- the American Academy of Pediatrics has really taken a stance that most of these over-the-counter products are not really that effective in children and should be really used on just a minimal basis, based upon symptoms the patient's having. For pregnant patients, actually, these -- the nonsteroidal drugs are not recommended for these patients and you really have to do a risk-versus-benefits assessment for those patients, especially those that are in their first half of the pregnancy, should really avoid taking NSAIDS.

  • 10:35:45

    REHMInteresting. Dr. Seides, I want to give you a personal reaction to Tylenol. If I have a really bad headache, I will take two Tylenol in the morning and the headache is usually gone by the end of the day. But the next day, I have a rebound headache. If I take no Tylenol, the headache is gone and it's gone the next day as well. What about that rebound factor?

  • 10:36:26

    SEIDESYou know, headaches are complicated and are due to many, many, many different factors. Most of them are tension headaches that are related to the musculature around the head and the scalp. I think it's difficult to generalize about this. This is something that's kind of an individual -- an individual phenomenon.

  • 10:36:50

    REHMBut do you never hear about rebound headaches?

  • 10:36:54

    SEIDESI'm not familiar with it but educate me.

  • 10:36:57

    REHMWhat about that, Bruce?

  • 10:36:59

    LAMBERTSo, Diane, rebound headaches are a well-known phenomenon. They're called analgesic rebound headaches or just rebound headaches. And what happens, if you take headache medicines, pain medicines, for a long period of time, your body can react in such a way that, when you stop taking them, you have a reaction which is another headache. And this gets into a very difficult cycle for people because once you've gotten into a cycle of sort of long-term use of these pain medicines and then rebound headaches, and then you take the pain medicine again for the rebound headache, it's very difficult ever to get out of that cycle.

  • 10:37:36

    REHMInteresting.

  • 10:37:37

    LAMBERTWhich is one more reason to be as conservative as possible and take as few medicines as possible.

  • 10:37:41

    REHMAll right. Bruce Lambert. And when we come back, we'll open the phones.

  • 10:40:00

    REHMAnd welcome back. Time to open the phones as we talk about new warnings from the FDA regarding over-the-counter pain medications. First let's go to Trussville, Alabama. Megan, you're on the air.

  • 10:40:22

    MEGANGood morning, everybody.

  • 10:40:24

    REHMHi.

  • 10:40:25

    MEGANMy question is if you have chronic pain, and prescription pain medicine just doesn't do well with your belly, so you try to manage it with over-the-counter, is that better or worse than if you were taking prescription pain medicine?

  • 10:40:45

    REHMThat's a very interesting question. Bruce Lambert.

  • 10:40:47

    LAMBERTSo the fact that you get a medicine with a prescription or without a prescription, it may not matter as much as you think because sometimes the same ingredient, or very similar ingredient, can be in the prescription and the non-prescription pain medicine. So what really matters is which specific medicine you're taking, not whether you got it by prescription or not. So as we found out today, just because these drugs are available without a prescription doesn't mean they're necessarily safer.

  • 10:41:15

    LAMBERTSo what you really need to understand is which drug are you taking and what are its particular risks, and there your local pharmacist can help you, or your doctor can help you understand.

  • 10:41:24

    REHMAnd?

  • 10:41:24

    LAMBERTSo just because we're getting it with a prescription or not doesn't mean it's more dangerous or safer.

  • 10:41:27

    REHMAnd just to follow up on that, here's an email from Kevin, who says I have chronic pain issue. I'm taking prescription Naproxen frequently, sometimes as much as five times a week. I have an overall low risk for heart attack, but should I still consider changing my pain medication? Dr. Seides?

  • 10:41:55

    SEIDESSo a couple things. I would say number one, maybe the only advantage of a prescription drug is at least you are under the supervision of a physician who's...

  • 10:42:09

    REHMPresumably.

  • 10:42:09

    SEIDESRight, who is prescribing it and a pharmacist who's dispensing it, as opposed to simply picking it up and going to the checkout counter. So to the extent that there's surveillance, that's a good thing. To directly answer the question, I think it's important to recognize that NSAID drugs, while we're focusing on cardiovascular risk today, heart attack and stroke, have other risks, as well.

  • 10:42:35

    SEIDESAnd somebody -- we've talked about GI bleeding, but I would also say that there is a risk of kidney failure, as well, with high doses of NSAIDs, particularly, and I would say especially, in younger people or in people who are prone to become dehydrated. So we've seen many times kidney failure in otherwise healthy individuals who have allowed themselves to exercise, become dehydrated, have muscle discomfort, take NSAIDs, and the next thing you know, your kidneys have failed. So...

  • 10:43:10

    REHMAll right, to Peoria, Illinois. Hi, Robert.

  • 10:43:13

    ROBERTHello. I have some comments on the GI effects of NSAIDs, namely causing bleeding and ulcers. And this -- these symptoms occur not uncommonly without premonitory symptoms, in other words a patient may be taking the NSAID, they may experience no abdominal pain, no nausea, no loss of appetite and then suddenly start passing black stools, indicating there is GI bleeding. What I think is best, if a person has to use NSAIDs is, number one, they use short-acting NSAIDs like ibuprofen rather than longer-acting NSAIDs, and they try not to take the NSAID for 24 hour coverage, in other words try to give their stomach and blood vessels a rest from the effects of the NSAIDs.

  • 10:44:17

    LAMBERTBruce Lambert, you're nodding in agreement.

  • 10:44:21

    LAMBERTI think this is so important because like I said, in the beginning, when these drugs first came out, the primary safety concern was around this GI bleeding, and GI bleeding, we think of an ulcer as just something that's painful, but people can and do die of these GI bleeds, and as the caller rightly says, they often have no symptoms. You have -- you may not even have ulcer pain, and suddenly you have this severe bleeding, which, if not treated as a medical emergency, can kill you.

  • 10:44:50

    LAMBERTSo I think this advice to take low doses, not to take it for 24 hours at a time, this is great advice, and it reminds us that with all the new attention on the heart attack and stroke risk, we shouldn't forget the old concern with these drugs, which was about the bleeding.

  • 10:45:07

    REHMIndeed. All right, to Kerry in Rochester, New York, you're on the air.

  • 10:45:14

    KERRYGood morning. I'm just wondering if these effects are cumulative, or if we know or not. In other words, if I take over-the-counter medication for pain periodically, NSAIDs in particular, and then stop, am I going to be okay, or do I need to stop because I've been taking it off and on for years?

  • 10:45:32

    REHMDr. Seides?

  • 10:45:33

    SEIDESI would say the data suggests that it is non -- that the risk is non-cumulative. If you stop taking it, given what we know about the mechanism, where we believe that the drugs affect an enzyme, and the effect of that is to change vascular phenomena, including our ability to clot, I think when you stop taking it, the risk goes away.

  • 10:45:59

    REHMAnd here is an email from Carol in Orlando, Florida, who says it's good to know about the risks associated with the NSAIDs, as well as other stronger prescription medications for pain, but the reality is that chronic pain patients often have no really good alternatives. What research is being done to look for new drugs with totally different mechanisms of action that are safer for long-term use? Deborah Pasko?

  • 10:46:43

    PASKOSo that is a great question. There are many patients that do have chronic conditions requiring pain medication for longer periods of time. The FDA, as well as others, have really done a great job of looking at all of these medications and specifically around prescription medications that are called opioids, so those would be things like morphine and oxycodone, et cetera, and looking at drugs that may be in clinical trials right now and the mechanisms of those drugs and trying to fast-track some of them if they do fall into certain categories that the FDA deems appropriate.

  • 10:47:26

    PASKOSo there is clinical research that is happening in this, and I would say there's also an awareness on a national level around the opioids specifically and that opioids are in the adverse drug event national plan, as well. So there is research being done in this area. It may not be as fast as some people would like or appreciate, but like any drug, it does take a while to study and get to market.

  • 10:47:52

    REHMHere's an email from Dee Dee, who says I'm 72, I've been taking 200 milligrams of Celebrex daily for over 10 years for arthritis. I could not have been comfortable without it. What would you say to her, Bruce Lambert?

  • 10:48:16

    LAMBERTI think if she could not have a comfortable life without these medicines, then these medicines are worth it for her. So in the end, you know, when we're sick, as we grow older, we face all sorts of risks, and to get the benefit of these medicines, we take on certain risks. So if the medicine is really returning a significant benefit, as this emailer says, it's allowing her to have a normal life without significant pain, that's a really significant benefit to her quality of life.

  • 10:48:52

    LAMBERTAs long as she realizes that, you know, a woman of her age has a significant baseline risk for heart attack and stroke and that these medicines are probably increasing that risk, if she's willing to take it on with full knowledge of it, I think it's a perfectly rational decision because pain itself has all sorts of negative adverse effects.

  • 10:49:04

    REHMCertainly.

  • 10:49:05

    LAMBERTPain can make you depressed.

  • 10:49:07

    REHMDr. Seides, do you want to comment?

  • 10:49:08

    SEIDESYes, well, and of course if someone becomes homebound, is unable to exercise, as Bruce is implying, I think that that -- if you look at a sort of a more holistic view of a person's health and well-being, that's a bad thing. I think it's also worth kind of putting it into perspective. The studies suggest that consistent use of NSAIDs increases your baseline risk by anywhere between 10 and 50 percent. So it's not an insignificant uptick.

  • 10:49:39

    SEIDESBut again, you've got to look at what your baseline risk is. So if your baseline risk is one in 50,000 or one in 100,000, even if you double that risk, it's still two in 100,000. So again, one needs to kind of frame all of this in your personal risk.

  • 10:49:58

    REHMSure. All right, to Al, who's in Cleveland, Ohio. Hi there, you're on the air.

  • 10:50:03

    ALThank you so much for taking my call.

  • 10:50:08

    REHMSure.

  • 10:50:08

    ALWell, I am 46 years old and this past May had unexpected quadruple bypass surgery. I was very fortunate that I had a great family physician who caught that, otherwise I probably wouldn't be around. But that being said, I also have no cartilage in both knees, and I have arthritis in both knees. I play racquetball, I play it very intensely, I'm not in pain when I play, but it's the aftermath of that, or it's the aftermath of doing a 50-mile bike ride.

  • 10:50:45

    ALAnd my question to you is, I have a prescription for Naproxen, but I haven't taken it since before the first of the year, just because I don't want to have any side effects from it. Is there something that you recommend that could be helpful to my knee joints, because I don't have cartilage, and I'm a survivor of quadruple bypass surgery at my age.

  • 10:51:05

    REHMDo I understand, Al, that you were also prescribed a high dose of Aleve?

  • 10:51:13

    ALI want to say it was -- all I know is that two -- my prescription is two over-the-counter Aleves at a time, was my prescription dose, whatever that is.

  • 10:51:27

    REHMOkay, Dr. Seides?

  • 10:51:31

    SEIDESSo this is -- you know, Al, you're a good example of someone where one has to balance risks and benefits. There's no question that because you've had coronary bypass surgery and therefore have underlying coronary artery disease, that your risk, your underlying risk of an event is heightened compared to somebody your age, a person who's not been in that situation.

  • 10:51:54

    SEIDESOn the other hand, the potential benefit is great for you because you exercise vigorously, and you have arthritis. You obviously have a physician, a group of physicians, whom you like, whom you trust. I think this is the moment of truth, where you sit down and say is it worth it for me, or isn't it worth it for me. You mentioned you hadn't taken anything I think since the first of the year.

  • 10:52:20

    ALThat's accurate.

  • 10:52:23

    SEIDESAnd if you've been able to get by since the first of the year without it, I would say keep going.

  • 10:52:29

    ALThank you very much. I'm very motivated with this new lease on life, and I appreciate any insight that you've given. So thank you so much.

  • 10:52:38

    REHMOkay, Al, thanks for calling. And you're listening to the Diane Rehm Show. Let's go to Barbara in Louisville, Kentucky. Hi, you're on the air.

  • 10:52:53

    BARBARAGood morning. My question is, and I've heard your guests mention the term doses of these particular medications, I am 70, occasionally when I overdo it, I might take a couple of 200-miligram over-the-counter ibuprofen, and sometimes it might be a couple days a week when I do that. Is that dangerous? What do you mean by high doses, and what is a dangerous level?

  • 10:53:27

    REHMBruce Lambert?

  • 10:53:30

    LAMBERTI think the pattern of use that the caller is describing would not be regarded as high dose according to the studies that have been done, and it may be some comfort to listeners to know that the vast majority -- the FDA relied on one particular study of studies, and the vast majority of heart attacks and strokes in that study of studies occurred in patients taking higher doses than this caller is taking and in patients taking over longer periods of time.

  • 10:53:57

    REHMHow do you define -- okay, but how do you define a high dose?

  • 10:54:02

    LAMBERTIt depends on the medicine, since all these medicines come in different doses. So I wouldn't want to say so on the radio. We can help you link to the place where people can look up their particular medicine and see what a high dose was in these studies, but since each drug has different strengths, one number isn't a high dose for each drug.

  • 10:54:21

    REHMDeborah, can you add to that?

  • 10:54:23

    PASKOSo exactly what Bruce had said of, you know, the study, the one particular one that he's citing, they did look at various doses in each one of the regimens, and again, ibuprofen dosing is different than, you know, Celebrex dosing versus others. And so to really comment on each one of those would be difficult. So I think, you know, putting a link on the website would be a good solution to this.

  • 10:54:50

    REHMAll right.

  • 10:54:51

    PASKOWhere people could actually look at the studies, at the doses that were in the study.

  • 10:54:54

    REHMDr. Seides?

  • 10:54:55

    SEIDESWell, I agree with both of my colleagues. In general, though, the dosing that you get in an over-the-counter medication is such that if we're talking about one or two of the tablets that, you know, are dispensed, usually ibuprofen comes in a 200-milligram tablet, I believe, one or two of those would not be considered a high dose over a 24-hour period. So...

  • 10:55:27

    REHMBut if you took, say, two of those every four hours over a 24-hour period, that's six doses. Would that be considered a high dose?

  • 10:55:43

    SEIDESYes.

  • 10:55:44

    REHMYes?

  • 10:55:44

    SEIDESYes, it would be.

  • 10:55:44

    REHMAnd if you continued to take that for, say, a week's period, that would not only be a high dose but would be considered dangerous?

  • 10:55:57

    SEIDESIt certainly would put you at a high risk of not only heart disease and stroke but really in a more worrisome way, the GI side effects and kidney side effects or renal side effects that I mentioned a few moments ago.

  • 10:56:13

    PASKORight, agreed (unintelligible) .

  • 10:56:13

    REHMSo you've got -- sorry?

  • 10:56:17

    PASKOAt those high doses, you have the potential for all of those events to be happening.

  • 10:56:24

    REHMIndeed. So clearly these labels are going to change. We're going to see new wording. Has there been any pushback, Bruce Lambert, from the manufacturing companies of these drugs?

  • 10:56:42

    LAMBERTI didn't attend the meeting, but generally speaking, as you can imagine, manufacturers are not eager to put new risks on their labels, and that's the case with these medicines, too. So I think in general, consumers should be wary that manufacturers might exaggerate the benefits and minimize the risks, and so I'm glad we had this opportunity today to talk about the risks.

  • 10:57:05

    REHMIndeed. Bruce Lambert, he's director of the Center for Communication and Health at Northwestern University. Dr. Stuart Seides is at MedStar Washington Hospital Center, and Deborah Pasko is director of medication safety and quality, at ASHP. Thank you all so much.

  • 10:57:30

    LAMBERTThank you, Diane.

  • 10:57:31

    PASKOThank you.

  • 10:57:32

    SEIDESThank you, Diane.

  • 10:57:34

    REHMAnd thanks for listening, all. I'm Diane Rehm.

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