FDA Drug Safety Communication: FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin
The U.S. Food and Drug Administration (FDA) is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. Many other products for these conditions are available that do not contain aspirin.
These widely used products already contain warnings about this bleeding risk on their labels; however, we are continuing to receive reports of this serious safety issue. As a result, we will continue to evaluate this safety concern and plan to convene an advisory committee of external experts to provide input regarding whether additional FDA actions are needed.
OTC aspirin-antacid products are sold under various trade names, including Alka-Seltzer Original, Bromo Seltzer, Medique Medi Seltzer, Picot Plus Effervescent, Vida Mia Pain Relief, Winco Foods Effervescent Antacid and Pain Relief, and Zee-Seltzer Antacid and Pain Reliever. They are also available as generic products.
Consumers should always read the Drug Facts label carefully when purchasing or taking an OTC product to treat heartburn, acid indigestion, or sour or upset stomach. If the product contains aspirin, consider whether you should choose a product without aspirin to relieve your symptoms.
Aspirin is a commonly used pain reducer and fever reducer. It is a nonsteroidal anti-inflammatory drug (NSAID) that can increase the risk of bleeding, including in the stomach and gastrointestinal (GI) tract. Ask your pharmacist if you need help reading the Drug Facts label.
If you have one or more of the following risk factors, you may have a higher chance of serious bleeding when taking aspirin-containing antacid products:
- Are 60 years or older
- Have a history of stomach ulcers or bleeding problems
- Take a blood-thinning or steroid medicine
- Take other medicines containing NSAIDs such as ibuprofen or naproxen
- Drink three or more alcoholic drinks every day
In 2009, a warning about the risk of serious bleeding was added to the labels of all OTC products that contain NSAIDs, including aspirin-containing antacid products. However, a search of the FDA Adverse Event Reporting System (FAERS) database identified eight cases of serious bleeding events associated with these products after the warning was added. All of these patients were hospitalized. Patients had underlying conditions such as the risk factors above that put them at greater risk for developing serious bleeding events (see Data Summary). The FAERS database includes only reports submitted to FDA so there are likely additional cases about which we are unaware.
Source : FDA (June 2016)
Aspirin Use Linked to Macular Degeneration
Regular aspirin use was associated with an elevated risk for neovascular age-related macular degeneration, an Australian study suggested, but actual causality remains uncertain.
After adjustment for age, sex, and history of smoking, the odds ratio for macular degeneration in aspirin users was 2.37 (95% CI 1.25 to 4.49), according to Jie Jin Wang, PhD, of the University of Sydney, and colleagues.
With further adjustment for body mass index, systolic blood pressure, and history of cardiovascular disease (CVD), the association remained (OR 2.46, 95% CI 1.25 to 4.83), the researchers reported online in JAMA Internal Medicine.
However, "the evidence is insufficient to adjudicate the relationship between aspirin and [age-related macular degeneration], thereby challenging causal inferences," Sanjay Kaul, MD, and George A. Diamond, MD, of Cedars-Sinai Medical Center in Los Angeles, wrote in an invited commentary.
A recent cross-sectional study suggested a possible link between neovascular age-related macular degeneration and routine aspirin use, but other studies have yielded conflicting findings.
To prospectively examine this potential link, Wang and colleagues analyzed data from the Blue Mountains Eye Study, which included 2,389 Australians ages 49 and older.
Retinal examinations were done every 5 years, and lesions classified as neovascular, or wet macular degeneration, or geographic atrophy, also known as dry macular degeneration.
Aspirin use was reported on a structured questionnaire, and information on relevant risk factors was obtained during physical examination and history reports.
A total of 257 participants were regular aspirin users. Compared with nonusers, they were older and more often had conditions such as diabetes, cardiovascular disease, or elevated blood pressure.
During 15 years of follow-up, age-related wet macular degeneration was identified in 63 individuals.
Among regular users, the cumulative incidence was 1.9%, 7%, and 9.3% at years 5, 10, and 15, while the incidence among nonusers was 0.8%, 1.6%, and 3.7%, respectively.
The incidence of neovascular macular degeneration rose with more frequent aspirin use, increasing from 2.2% in those who never took aspirin, to 2.9% for those who used it only occasionally, and 5.8% for those who took aspirin routinely.
Aspirin use was not associated with risk for geographic atrophy.
Additional secondary analyses found that the risk was four times higher in patients with a history of CVD (OR 4.36, 95% CI 1.24 to 15.32) and in those without a polymorphism on CFHY402H, a gene involved in the complement pathway that has been linked with macular degeneration (OR 4.17, 95% CI 1.05 to 16.49).
The researchers also considered whether other medications often taken by aspirin users, such as acetaminophen and beta-blockers, might influence risk, and the results were negative.
These results create a quandary for the many patients using aspirin, particularly those taking the drug as secondary prevention of CVD, according to Wang's group.
"Aspirin is one of the most effective CVD treatments and reduces recurrent CVD events by one-fifth," they observed.
However, significant adverse events can occur, such as cerebral and gastrointestinal bleeding.
"Our present study now raises the possibility that the risk of neovascular [age-related macular degeneration] may also need to be considered," they stated.
Nonetheless, they conceded that the risk is small, at slightly under 4% over 15 years, and the evidence is thus far insufficient to support a change in practice away from widespread aspirin use, except for patients at very high risk for macular degeneration.
Any risk-benefit analysis also must consider the availability of effective -- but expensive -- treatments for neovascular age-related macular degeneration.
"Any decision concerning whether to stop aspirin is thus complex and needs to be individualized," they wrote.
Limitations of the study included the possibility of confounding by indication and a lack of information on the reasons why participants were taking aspirin.
In their invited commentary, Kaul and Diamond wrote, "These findings are, at best, hypothesis-generating that should await validation in prospective randomized studies before guiding clinical practice or patient behavior."
They also advised that the choice of whether to use aspirin should focus on whether the indication is for secondary CVD prevention, "where the benefits of aspirin are indisputable and greatly exceed the risk," or for primary prevention, where the evidence is less clear, as well as the extent of the person's risk for macular degeneration and bleeding.
"In the final analysis, decisions about aspirin use are best made by balancing the risks against the benefits in the context of each individual's medical history and value judgments," they added.
Other experts, such as Shawn Wilker, MD, of University Hospitals Case Medical Center in Cleveland, agreed on the importance of individual risk.
"I think a reasonable circumstance when you could ask a patient not to take aspirin might be one in which there is a very low risk of mortality from cardiovascular disease or if that person is at very great risk of losing vision from macular degeneration," Wilker said in an interview.
Journal editor Kenneth E. Covinsky, MD, also weighed in in an editor's note, stating that "as with many good studies, the data are not definitive enough to suggest changes in clinical practice."
"Rather, we hope the study galvanizes more research on the relationship between aspirin and macular degeneration," Covinsky wrote.
Source : MedPage Today via
JAMA Internal Medicine
Source reference: Liew G, et al "The association of aspirin use with age-related macular degeneration" JAMA Intern Med 2013; DOI: 10.1001/jamainternmed.2013.1583.
Additional source: JAMA Internal Medicine
Source reference: Kaul S, Diamond G "Relationship of aspirin use with age-related macular degeneration" JAMA Intern Med 2013; DOI: 10.1001/jamainternmed.2013.2530.
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Aspirin's Mostly Unrecognized Connection to Serious Medical Problems
It has been more than a decade since I stopped recommending aspirin for the prevention of heart disease. The evidence in support of aspirin has always been quite weak, and over the last decade it has become even weaker. In fact, it looks as though aspirin, even "low-dose aspirin" (LDA), may do more harm than good. It is debatable whether or not aspirin may have some beneficial actions in heart disease protection.
However, recent scientific studies have uncovered a number of serious side effects that suggest any benefits of aspirin, just like statins, may be overshadowed by its risks, especially when safe and effective alternative measures of prevention exist.
As is true with nearly all medications, the longer we look at side effects, the more we find—even for drugs like aspirin that have been around for more than 100 years.
Aspirin's Effectiveness has Been Overvalued Nearly ten years ago, Dr. John G. F. Cleland, a cardiologist from the University of Hull in the U.K., wrote an excellent article published in the British Journal of Medicinei casting doubt upon the efficacy of aspirin therapy for prevention of heart attacks.
Based on a series of meta-analyses from the Antithrombotic Trialists' Collaborationii, which is an enormous body of research following more than 100,000 patients at high risk for cardiac events, Dr. Cleland concluded aspirin therapy was NOT shown to save lives.
He made the following main points:
- Antiplatelet activity of aspirin is not as safe and effective as widely believed.
- All large, long-term trials involving people treated with aspirin after having a heart attack show no benefit for mortality. In other words, those who take aspirin don't live any longer than those who don't.
- Aspirin seems to change the way vascular events present themselves, rather than preventing them. The number of non-fatal events may be reduced, but there is an INCREASE in sudden deaths. Aspirin may conceal a cardiac event in progress.
More Science Showing Aspirin's Dismal Failure In 2004, Dr. Cleland published the results of a new study (Warfarin/Aspirin Study in Heart Failure, or WASH) in the American Heart Journal in which he investigated antithrombotic strategies in 279 patients with heart failure. He found that the patients who received aspirin treatment actually showed the worst cardiac outcomes, especially worsening heart failure. Dr. Cleland concluded there was "no evidence that aspirin is effective or safe in patients with heart failure."
Then in 2010, another studyiii looked into whether or not patients taking aspirin before an acute coronary syndrome (ACS) were at higher risk of recurrent problems or mortality. ACS is a term used for any condition brought on by sudden, reduced blood flow to the heart, such as a heart attack or unstable angina. The study found that patients who were taking aspirin showed a higher risk for recurrent heart attack and associated heart problems.
Thus far, aspirin's performance is quite unimpressive. But what about aspirin's benefits specifically for women? As it turns out, aspirin fares no better with women.
In 2005, Harvard conducted a studyiv to investigate whether or not low-dose aspirin offered cardiovascular benefits for women. They followed nearly 40,000 healthy women for a full 10 years. Again, the results did not show any heart benefit from aspirin therapy; researchers concluded aspirin did NOT lower the risk of heart attack or death from cardiovascular causes among women.
Aspirin Never Proven Safe or Effective for Diabetics Cardiovascular disease is a serious concern if you have diabetes, and a number of studies have set out to determine whether aspirin can offer a degree of protection. Three studies have shown the benefits to be either inconclusive, or nonexistent.
- In 2009, a study in the British Medical Journalv found no clear evidence that aspirin is effective in preventing cardiovascular events in people with diabetes. Results differed between men and women, but overall, they found no clear benefit and called for more studies on aspirin's toxicity.
- Also in 2009, a Swedish studyvi examined the effects of aspirin therapy in diabetic patients. Researchers found no clear benefit that aspirin is beneficial for diabetics but did note that it can increase the risk for serious bleeding in some of them. They stated that the current guidelines for aspirin therapy should be revised until further study is done.
- In 2010, a meta-analysisvii in the U.K. examined six trials consisting of 7374 diabetic patients, comparing the relative cardiac risks for aspirin users and non-users. They concluded, as did the other researchers, that aspirin did not reduce heart attack risk for diabetic individuals.
Aspirin Increases Your Risk of Hemorrhage, GI Damage, and Several Other Problems Routine use of aspirin has been associated with the following problems:
- Bleeding, especially in the gastrointestinal tract
- Duodenal ulcers, GI damage, and diverticular disease
- Increased risk of ER/PR-negative breast cancer in women
- Increased risk of kidney failure
- Cataracts, hearing Lossviii and tinnitusix
You can certainly understand how a bleed is possible, given what is known about the effects aspirin has on your GI tract.
For example, a studyxii done earlier this year investigated the effects of low-dose aspirin on the gastrointestinal tracts of healthy volunteers. After only two weeks, the group receiving aspirin showed "small bowel injuries" capable of interfering with blood flow (diagnosed upon endoscopic examination). And a 2009 Australian studyxiii showed that aspirin causes gastroduodenal damage even at the low doses used for cardiovascular protection (80mg).
The damage to your duodenum—the highest part of your intestine into which your stomach contents pass—can result in duodenal ulcers, which are prone to bleeding. A Japanese studyxiv found a higher incidence of bleeding at the ulcer cites of patients with duodenal ulcers taking low-dose aspirin therapy, versus those not taking LDA. More than 10 percent of patients taking low-dose aspirin develop peptic ulcers.
The risk of bleeding is particularly pronounced in the elderly, which is very concerning as the elderly are often put on aspirin prophylactically to protect against cardiovascular disease. With all of these adverse effects, why risk it when there are safer and more effective alternatives? One of those alternatives is a relatively new emerging field called Earthing—meaning, grounding your body to the Earth.
How Earthing can Affect Your Blood Earthing may actually be one of the best-kept secret strategies for preventing blood clots. In its simplest terms, Earthing (or grounding your body) is what occurs when you walk barefoot upon the Earth. There is a transfer of free electrons from the Earth to your body. And these free electrons are probably some of the most potent antioxidants known to man. These antioxidants are responsible for the clinical observations seen in Earthing experiments, such as:
- Beneficial changes in heart rate
- Decreased skin resistance
- Decreased inflammation
Virtually every aspect of cardiovascular disease has been correlated with elevated blood viscosity.
Earthing experts Dr. Stephen Sinatra and Dr. James Oschman measure blood viscosity using a method called zeta potential, which is a measure of how quickly your red blood cells migrate in an electrical field. When you ground to the earth, your zeta potential quickly rises, which means your red blood cells have more charge on their surface, forcing them away from each other.
Earthing causes your blood to flow more easily and your blood pressure to drop.
It follows then when your red blood cells become more electro native they are less inclined to stick together and form a clot. They actually repel each other similar to two magnets with the same pole.
Blood clots don't have to be very big to form a mass that could kill you instantly (such as pulmonary embolus), so this is an important part of lowering your risk for heart attack, stroke, and multi-infarct dementias, where you start losing brain tissue due to micro-clotting in your brain.
This is what many physicians erroneously believe low-dose aspirin is doing for you, and why it's so widely prescribed. The problem is, as you have seen from the studies summarized above, science just hasn't been able to prove that aspirin does what it was intended to do. Rather, studies show that aspirin has several dangerous side effects.
Other Recommendations for a Healthy Heart The real key to preventing heart disease is to use a combined approach, one that treats all facets of your physical and emotional health. Make sure you are addressing the following lifestyle factors:
- Restrict your consumption of fructose to less than 25 grams per day. High sugar intake, especially fructose, is directly tied to cardiovascular disease.
- Avoid processed foods, preservatives, additives, artificial sweeteners and grains as much as possible, and eat a good proportion of your food raw. Make sure your diet contains abundant fresh organic vegetables and high quality protein.
- Incorporate a high quality animal based omega-3 fats into your diet to optimize your omega 6:3 ratio. An excellent animal source of omega-3 is krill oil.
- Make sure you are getting adequate vitamin D (ideally from sun exposure) and vitamin K, since both are necessary for good cardiovascular health.
- Be sure you're getting enough exercise, and the right kinds of exercise. I highly recommend taking a look at my Peak Fitness program.
- Optimize your sleep, which is essential for every aspect of your health.
- Optimize your body weight and composition, and keep an eye on your blood pressure, blood glucose and insulin levels, iron level and lipid profile.
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Baby Aspirin keeps Heart Attacks Away - or does it
A baby aspirin a day keeps a heart attack away. This widely accepted health practice was seriously undermined at an advisory committee meeting of the Food and Drug Administration (FDA, held in December 2003. The FDA advisory committee voted overwhelmingly to reject a petition from the Bayer Corp. to approve aspirin for reducing the risk of a first heart attack.
Though an estimated 20 million Americans already take low-dose aspirin daily to prevent a heart attack, this is an off-label use—that is, the aspirin manufacturers have not received FDA approval for this particular indication. FDA approval is required, however, once an aspirin manufacturer plans to advertise the drug for this use. And once approval is granted, the drug's packet insert must be rewritten to inform consumers of the new indication.
Bayer's petition made the FDA Cardiovascular and Renal Drugs Advisory Committee take a critical look at the five trials (One trial compared aspirin with vitamin E) in which people without heart disease took either aspirin or a placebo (a dummy pill). Altogether there were more than 55,000 participants at anywhere from low to high risk for a heart attack. Here is what the cardiologists and other experts on the committee found in the way of benefit: Aspirin produced about a 32% reduction in non-fatal heart attacks. [Translation: An estimated 3% of all moderate-risk people will have a heart attack in the next five years. Daily low-dose aspirin therapy will reduce their odds to about 2%.] The benefit is given in terms of a five-year period because the trials lasted four to seven years.
Several things troubled the FDA committee members about the results of these trials: Aspirin did not have any mortality reduction benefit; nor did it reduce the odds of having an ischemic stroke, which is, arguably, the most feared consequence of heart disease. Yet aspirin has the potential for causing another, less common type of stroke called hemorrhagic stroke, which is a rupture of a blood vessel in the brain.
One committee member who voted to reject Bayer's petition is Steven Nissen, MD, Medical Director of the Cleveland Clinic Cardiovascular Coordinating Center. In a telephone interview, Dr. Nissen explained, “The data [from the five trials] were terribly weak.” You always have to weigh the trade- offs , he said, referring to hemorrhagic stroke as the major concern.
But the aforementioned 32% reduction in non-fatal heart attacks applies to the combined total of all the study participants, most of whom were men with differing levels of risk. The committee hit a snag once it came to individuals. Dr. Nissen said that he and other committee members were concerned that daily aspirin, if taken by people at a low enough risk, could cause more harm than good. Asked to define “low enough risk,” he explained that there was too much uncertainty to answer the question. “No one in the world can answer the question of who benefits and who doesn't, and if there is no answer, then how could I vote to approve?” he asked.
The fact that women were underrepresented in the five trials (only 20% of all participants) also troubled Dr. Nissen. “It may be that the risks exceed the benefit for women,” he said, “but we simply don't know—there is not enough data.” Still, Dr. Nissen was careful to stress that he was not against aspirin therapy for everyone, suggesting that people talk over the decision with their physicians. The FDA advisory committee “took a lot of heat,” said Dr. Nissen, referring to its decision to turn down Bayer's petition and thus reject the prevailing medical view that aspirin therapy is good for just about everyone. “We were called flat earthers ,” he said.
The FDA is not obligated to follow the decisions made by its advisory committees, but the agency usually does. The committee's decision, though entirely appropriate, illustrates how the current system works against consumers who want to become fully informed before they go on lifelong drug therapy. Approval would have meant a rewrite of the drug's packet insert to include the new indication. And this, in turn, would have compelled the advisory committee to identify
the appropriate group of people for whom the benefit of aspirin therapy clearly outweighs the
risks. The evidence from the five trials did not provide the answer; therefore, 20 million people will continue to take daily aspirin without knowing anything about the uncertainties of the supporting research.
The advisory committee's concerns can be contrasted with the practice guidelines aimed at physicians and published in 2002 by the U.S. Preventive Services Task Force. The Task Force concluded that the number of “cardiac events” prevented by aspirin therapy far exceeded the number of hemorrhagic strokes caused by aspirin therapy. This, too, is based on the combined results of the same five trials. When the Task Force tried to break things down for individuals, it came up with this estimation for moderate-risk men and women: “For 1,000 patients with a 3% risk of having a heart attack in the next five years, aspirin would prevent eight heart attacks but would cause one hemorrhagic stroke and three major gastrointestinal bleeding events.”
Where it concerns low-risk people, the Task Force is in agreement with the FDA advisory committee: MMMM
“…patients at low risk for coronary heart disease probably do not benefit from and may even be harmed by aspirin because the risk for adverse events may exceed the benefits…” (Annals of Internal Medicine, 1/15/02).
For More Information:
-Go to www.med-decisions.com to see one method used by the Task Force to identify different levels of risk for a heart attack. The Task Force used an additional assessment tool based on the risk information from the Framingham Heart Study, which has since become outdated.
-The transcript of the December 8-9, 2003 meeting of the Cardiovascular and Renal Drugs Advisory Committee is likely to be posted on the Internet in February or March. Go to www.fda.gov and click into “Advisory Committees.” Then go to this specific committee and its meeting date.
Source : Maryann Napoli, January 2004