FDA Comes Out Against Aspirin for Primary Prevention — Physician’s First Watch

Medical News |
May 6, 2014

FDA Comes Out Against Aspirin for Primary Prevention

By Larry Husten

Aspirin shouldn't be marketed for primary prevention of heart attack or stroke, the FDA has announced. The statement follows the agency's rejection on Friday of Bayer Healthcare's decade-old petition requesting approval of a primary prevention indication.

Aspirin is still widely used for primary prevention. The American Heart Association currently supports its use for primary prevention when recommended by a physician in high-risk patients. (There is widespread agreement that for secondary prevention, aspirin's benefits outweigh the risks, and it should be used to prevent a second heart attack or stroke after an earlier cardiovascular event.)

In its statement, the FDA said it had "reviewed the available data and does not believe the evidence supports the general use of aspirin for primary prevention of a heart attack or stroke. In fact, there are serious risks associated with the use of aspirin, including increased risk of bleeding in the stomach and brain."

Reader Comments (20)

Ian Light MBBS Physician, Family Medicine/General Practice, Melbourne Victoria

Has it been assessed in high risk cardiovascular disease Framingham>30 over 10years Diabetics Obesity according to stratification

Jayanta Bhattacharya, MBBS, PhD Physician, Family Medicine/General Practice, Raiganj, West Bengal, India

Like many other countries, Indian practitioners too are very often guided by some received "medical traditions". I am afraid this could be the most formidable hindrance to change the paradigm of practice. Moreover, alternatives to paracetamol to control pain and fever should be critically and clearly stated. Finally, how much evidence is there so as not to prescribe 500 mg of paracetamol for the fear of hepatic failure is not quite convincing.

Bernd Gansbacher

What about the benefit regarding colorectal carcinoma? Is that now revoked as well?

Bernd Gansbacher

What about the benefit regarding colorectal carcinoma? Is that now revoked as well?

JEFFERY HOOPER Other Healthcare Professional, Dentistry, Private practice

What about vit d3 deficiency?

80% of my patients are insufficient & 40% deficient

Most of my patients with CV problems had grosse d3 deficiency

D3 supplement is dirt cheap and not manufactured by major pharm's. 6-12 cents per day together level up

Vern chichak Physician, Internal Medicine, Canada

When questioned about primary prevention patients taking Asa often take it without ever discussing it with their doctor and have never been formally prescribed it and simply take it over the counter as it seems entrenched in our psychic it is a good thing to you

Edd Thomas, MD, PE Physician, Emergency Medicine, out patient, high volume urgent care

Big Pharma?? Really? This shows how little residents know about business or medicine. Take a look around a pharmacy. The generics dominate by far in 81mg ECASA.
Since my patients having acute mi's, over 25 years of running emergency departments, seemed to start around 40 years of age, I start there at pushing for daily 81mg ECASA. I do NOT care what the politically correct FDA or other statistical engine site might say. The cost is miniscule. There is no significant side effect outside of the rare individuals WITH other risk factors unless you can show me a cheap test for berry aneurysms.

Hammond Williamson, MB ChB Dip Obs Dip MSM FRNZCGP Physician, Family Medicine/General Practice, New Zealand

Aspirin side effects are very common and become more obvious with age. Twice I have seen intracranial hemorrhage attributed to aspirin. Often dysypepsia and vague bloating and malaise and not uncommonly a PPI is prescribed for this.

Yoel Korenfeld, MD Resident, Internal Medicine, Minneapolis

Not to long ago my best friend, a neurosurgery resident at a prestigious program, who happens to be exactly my same age (actually a month younger, 33 this year) asked me what did I think about him starting to take a daily aspirin for primary prevention of MI, stroke and colorectal cancer. I discouraged him to do so. He is young and other than having the worst quality of life in terms of sleep, diet and exercise, he is a very healthy dude. There are no data available to date to justify taking a daily pill for the rest of his life. These type of interventions are the ones that bring healthcare cost up, not only for the person taking the "supplements" or aspirin or any other compound that has not shown evidence, but for everybody else as well. The only reason to take a daily aspirin in these days is for secondary prophylaxis after MI and stroke. Data from a large trial published in the journal last week (POISE-2) show that aspirin prophylaxis around surgery is deleterious and increases the risk of bleeding without any additional benefit in terms of CVD prevention. The fact that is a cheap intervention should not justify it, as it may cost ten cents per day but if you multiply that for a lifelong therapy for millions of healthy individuals, the expenditure is outstanding. Don't let pharma full you on this one, no data in these cases should mean to you "stay away from the drug" not "lets keep trying it, the cost is little and there may be some benefit".

Lew Iacovelli PharmD Other Healthcare Professional, Oncology

But they are comfortable approving drugs that cost tens of thousands of dollars for cancer that extend survival for a month???????

Judith Andersen Physician, Hematology, Detroit Medical Center

Although the reasoning underlying the FDA's opinion on aspirin use as primary prevention of myocardial infarction and stroke seems sound, it is not entirely clear why this opinion needed to be voiced. Of the host of over-the-counter drugs available for casual use by the average American citizen, aspirin seems among the most innocuous. Yes, it has obvious potential side effects -- and no, the optimum safe dose for effective primary prevention of vascular catastrophe in the "average" American is hardly clear. But an opinion voiced by the FDA that there is no support for and that there are dangerous side effects associated with its general use for this purpose may make it difficult for physicians to recommend it to patients for whom it may be useful and safe. The decision underscores the importance of a larger issue: the remarkable availability of any number of compounds (dietary supplements, OTC remedies for all manner of minor ailments, food items with purported "healing" properties, etc.) to any American with the financial resources to indulge in such use. I see little need for this proclamation and an unfortunated potential avoidance of aspirin's use in those individuals for whom it may be of primary benefit when recommended by a knowledgeable physician.

Mussadique Ali, MBBS Resident, Internal Medicine, SKMCH&RC, Lahore, Pakistan

Was insearch for this!! Thanks God I'll not now prescribe aspirin to every new commer!

JOAO ALMEIDA Physician, Cardiology, Cínica de Cardiologia Dr. Joao A Almeida

It is an important issue because it often happens aspirin be used for primary prevention particularly in older age groups

Kuan Fu Liao Physician, Gastroenterology, Taiwan

need more evidence for aspirin in prevention of CAD

ALINE RIBEIRO Physician, Family Medicine/General Practice

Boa decisão!

Martha H Howard, MD Physician, Family Medicine/General Practice, Group practice

Is this a medical decision or a political one? How can an inexpensive, widely available remedy be safe for prevention of a second heart attack, but not for prevention of a first one? I'm going with the American Heart Association guidelines.

SEW JANKI PRASAD Physician, Family Medicine/General Practice, FRANCE

More fundamental research is required.

Suhail Marfani Physician, Internal Medicine

How about aspirin use in the primary prevention of stroke and heart attacks in the diabetic and /or CKD.

Richard Molinaro, Pharm.D. BCPS Other Healthcare Professional, Internal Medicine, Houston San Jacinto Methodist Hospital

I am interested in ACC/AHA/ESC and ACCP responses

GEORGE PALMER Other Healthcare Professional, Health Law/Ethics/Public Policy, UNSW

There surely is a question of the dosage of aspirin used. Is there any evidence that a daily intake of 100 mg would generate the side effects mentioned?

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