Aspirin is on TV nearly every day as a the first line defense for preventing heart-attacks. Interestingly, a few months ago, there was a 60-Minute program discussing how new discovery shows that Aspirin doesn’t actually help women in the case of heart attacks but rather help with stroke and for men it helps with heart but not with stroke. This was an interesting story and I wondered why, after this information, Bayer was continuing to advocate Aspirin as heart attack prevention aiming at women.
Well, I suppose my question was answered: Bayer was not supposed to advertise Aspirin for women and actually not even for men who had no heart attacks before!
On May 2nd 2014 the FDA came out with new regulation preventing Bayer to claim that Aspirin provides protection, can prevent, or even help a first heart attack. In other words, Aspirin is not a first prevention medicine anymore. How life changes! And how few listen and pay attention! If you go to visit your doctor today and ask, I bet he/she will tell you to take an Aspirin every day, the baby 81 mg one, to prevent a heart attack once you are over the age of 50.
I hear doctors tell me all the time that everyone over 50 should take a baby Aspirin! Well I guess not! You can read the argument and the final decision with the many case studies that showed no effect of Aspirin on those with first case of a heart attack or prevention of them. Aspirin apparently neither prevents nor helps a heart attack as long as the person does not have a history of heart attacks!
Here is a quote from the FDA’s new regulation:
FDA has reviewed studies on the use of aspirin for the prevention of a first cardiovascular event (primary prevention) and did not find sufficient support for the use of aspirin for primary prevention in these trials. FDA is currently awaiting results of additional clinical trials that are underway and are estimated to have reportable results in the next few years. These clinical trials may provide new evidence that could be the basis for changing the current uses (indications) for aspirin….
FDA recently denied a request submitted by Bayer HealthCare, LLC, requesting a change in the prescribing information for health care professionals (professional labeling) for aspirin to allow marketing of the product for prevention of heart attacks in patients with no prior history of cardiovascular disease.
After the 2003 advisory committee meeting, FDA was aware of several ongoing studies for primary prevention in patients with diabetes and diseases of the arteries and veins located outside of the heart and brain (peripheral vascular disease). We opted to wait for the outcome of these studies. The results of these studies were published over the past several years. They did not demonstrate a significant benefit for primary prevention….
The Centers for Disease Control and Prevention’s (CDC’s) national initiative, the Million Hearts Campaign, is focused on increasing appropriate, secondary prevention aspirin use in individuals who already have heart disease or stroke. The CDC, in its Million Hearts Campaign, agrees with FDA’s position.
The National Heart, Lung, and Blood Institute (NHLBI) recommends, as does FDA, the use of aspirin for secondary prevention. Specifically, NHLBI recommends using aspirin to lower the risk of a heart attack for those who have already had one, and to keep arteries open in those who have had a previous heart bypass or other artery-opening procedure such as coronary angioplasty.
Should you throw your bottle of Aspirin away? If you never had a heart attack, yes, throw Aspirin out. It causes stomach problems, insults GERD further–can create GERD in fact–and its most important benefit that we thought was true is not true. So throw it away until you have a heart attack. Can you prevent heart attack without Aspirin? Absolutely! Eat right, exercise, stop eating sugar, drink more water, be happy. You will less likely to have a heart attack if you have a healthy lifestyle.
When should you take Aspirin? If you already had a heart attack or a stroke, do have Aspirin with you. Depending on what other medications you may take, you may not be able to take Aspirin also unless you are experiencing a heart attack. Thus its use is limited as of now. But stay tuned, things may change! We live in a dynamic world!
Comments are welcome as always!
As a comment I received an article that just published by JAMA that is the leading medical research journal. A friend sent it (thanks Roald!) and I thought that for those of you interested in a more technical and scientific data that is most recent will appreciate a longitudinal study that was stopped prior to reaching mid-time of the clinical trial because it showed that there was absolutely no benefit of aspirin on heart or stroke or hypertension or anything on a large population tested in Japan. So Aspirin a day? Nah.. forget it… go for a walk!
LikeLiked by 1 person
Stupid moderation again. Such crap!
LikeLiked by 1 person
Thanks Roald–darn spammer…. but managed to catch it. 🙂 thanks for the article. The moderator hates links… But that’s OK, I catch it. 🙂 Except when I will be in Costa Rica soon. Then it may have to wait.
I will insert the link to the article into my post. 😀 Totally lines up with what I wrote. Than k you!
Hi Angela, Nice article.
I do not take Aspirin and it was never indicated as primary prevention but rather secondary prevention after a heart attacks or strokes and off label use in people with multiple risk factors.
Aspirin itself is not a benign medication but works for many patients. I cannot tolerate aspirin or NSAID because of dizziness.
Aspirin appears to be effective secondary prevention in those who can tolerate it. The most common reason I encountered for stopping ASA was bleeding….it irreversibly inactivates the cyclooxygenase (COX) enzyme which takes 10 days restore…the reason ASA is stopped at least 10 days prior to surgery and should be avoided in acute hemorrhagic strokes.
Amitriptyline is another drug with off label uses. Started as tricyclic antidepressants…froth with side effects at high doses. Used more for pain control, MIGRAINES and sleep rather than depression. Tricyclic overdoses are serious, toxic and often fatal.
Aspirin and Amitriptyline are old medications, still effective in subgroups of patients.
Angela, there are studies underway to tailor medications to the individual as people respond and tolerate medications differently. Until we can customize medications to the individual….there will always be severe adverse and idiosyncratic reactions…..and even then.
Virtually all medications have off label uses and many patients benefit from those uses. The key is monitoring through medication management.
LikeLiked by 1 person
Hi Angela! Nice to see you (an MD) commenting on the Aspirin debate! 😀 I agree with you for perhaps your side of the US but in California adds on TV run (I just saw one a week ago!) on Aspirin for women for heart attack prevention as the first line of prevention and that is actually in many ways against the law for them to advertise after the FDA ruled that they cannot make that statement.
I have doctors tell me even today that I should take Aspirin “because everyone over 50 should be on one a day Aspirin”… blah… so while yes, SOME doctors, like you, may know the problem, you are probably a drop of gem in a bucket in Plato’s Cave. But yes, even the FDA suggests that as a secondary prevention it is good–unless the patient is put on some more aggressive preventive, like Warfarin Sodium (Coumadin) for prevention, in which case Aspirin would be counter indicative.
As for off-label use… I have a very strong article on this blog against off-label use of drugs. I know that the FDA permits it (for now).. it is under attack and will be under attack for as long as it is possible to do because that is experimenting with drugs that were not tested or approved for that use specifically. On this the FDA has a conflict in its regulation that I will go after once the many jars my hands are in now are free. Because on the one hand I cannot manufacture a drug and start selling it without FDA approval and its precise label restrictions yet on the other hand a drug can be used for something it was not labeled for with the vague statement “your doctor may prescribe this medication for other conditions not listed.” This is a 100% counter point to the FDA’s mandated “no change in label” for the drug that was approved because that “label” that has to be so precise, actually did not include the drug to be used for illnesses other than what it was approved for… All illnesses and types of conditions (in case of antibacterial agents even the list of bacteria the drug works on) must be included in the label.
I will address this confusion when my time allows. 😀
LikeLiked by 1 person
Glad you were not taking it. Me neither. 😀 Amitriptyline is Elavil and bad news because it is a TCA (a tricyclic antidepressant) that affects many things (systemic) all through the brain. It has hundreds of adverse side effects and interacts badly with everything except air… it acts as a serotonin-norepinephrine reuptake inhibitor which means it plugs the hole for 2 types of neurons to know they manufactured enough: serotonin and norepinephrine so the brain is flooded with both. serotonin overload can cause serotonin syndrome–from a single dose if one has enough–and also a lot of GI and IBS symptoms. Norepinephrine is a natural pain killing neurotransmitter so if and when the person wants to stop this medicine chronic pain will be a nightmare. I am very much against double reuptake inhibitors.. one is already too much. Plus, for depression, only about 30% of the people gain any benefit and only those whose brain is not able to make enough serotonin (why not should be the question, no?) and have clinical depression. Otherwise it will lead them ever so close to being dumb dumb for awhile since its systemic so it effects these all through the brain… Avoid is my recommendation!
A doctor here explained to me that a daily dose of 10 mg amitriptyline could help to restore the balance between the parasympathetic and sympathetic nervous system. Any thoughts on that?
Well, let’s see if that can be true (it is not but let’s look at it). Sympathetic nervous system is the one that controls (or aids in) your body’s information about fight-or-flight and is under automatic involuntary control: body temperature, heart beat, lung with oxygenation, digestions, etc. All of those kick in when you perceive danger and get a panic attack that results in the fight-or-flight. The parasympathetic nervous system is the one that connects to the spine and does tasks such as writing, typing with sore fingers like I am tonight, walking on a hike, etc. In other words, they are not under the control of your automatic system. They are under control of your voluntary nervous system.
I believe the imbalance between the two your doctor is referring to is that when we are hit with a panic attack (perceived or real cause), the involuntary automatic systems kick into action and fight-or-flight mode follows with negative consequences. The fight-or-flight activates the following among other things: shuts down unnecessary body operations so digestions stops. This is the time people throw up if they have undigested food in their stomach and empty their bowel as well–need not be diarrhea only a very large emptiness is left behind. The same system also activates your heart to pump blood faster and with greater pressure, your lungs need more oxygen so your breathing will be faster, adrenaline is released so you can run faster, etc.
So the connection between the sympathetic and the parasympathetic is that the sympathetic tells your legs to run off all that adrenaline but you are sitting and looking at the waves. What you would need to do is run to get rid of adrenalin but by sitting you get it built up resulting in RLS (Restless Leg Syndrome). What Elavil does is it blocks the channels that can be stimulated for the fight-or-flight response by your body so if a car is about to hit you, you will not be able to jump away. You need to decide if the benefits are worth the risks. The risk is that the drug is systemic all through your brain and so communication between your two systems will slow in every part of your body.
Among the many side effects that are very common in Elavil are impotence, insomnia, agitation, delirium, all kinds of GI issues… so think well before you jump on Elavil.
In contrast, at about the same time Elavil came out, so did some benzodiazepines, such as Valium. They have gotten a bad reputation by doctors saying how addictive they are but the truth is they are less addictive than most anti depressants (Elavil is in the antidepressant category). The number of adverse side effects of Elavil is like 50. The number for Valium is 5. You chose!
I choose……..none of the two 😛
Juicy detail: Years ago when I regularly had to lay down on an operating table, Florence Nightingale resembling nurses wanted me to swallow Valium 20 to ease my alleged fear for surgery. I told them to keep the stuff as I wasn’t afraid at all, and also had learned from past experiences……..the drug didn’t do anything to me.
LikeLiked by 1 person
Ugh, I don’t need to throw it away as I never took it, although a cardiologist once advised me to take that baby formula crap just to be sure. Of course, I immediately threw his expert opinion in the next garbage bin 😀
Btw, since I’m here, what’s your take on amitriptyline?
LikeLiked by 1 person