Aspirin is one of the most commonly used medications worldwide. It has been available over-the-counter for decades and is a staple in many medicine cabinets. However, regular aspirin use does come with some risks that consumers should be aware of.
In September 2022, the U.S. Food and Drug Administration (FDA) announced that aspirin will now come with a new warning highlighting the increased risk of bleeding in the stomach and brain for certain groups of people. This update comes after a thorough review of scientific evidence on the benefits and harms of aspirin use.
Who is affected by the new aspirin warning?
The FDA’s new warning on aspirin labels is targeted towards specific higher-risk groups including:
- Adults over 60 years old
- People with a history of stomach ulcers or bleeding disorders
For these populations, taking aspirin may pose elevated risks that need to be considered. As we age, our risk of bleeding complications increases, especially in the stomach and brain. People over 60 are already at higher baseline risk for dangerous bleeding events, and regular aspirin use further amplifies this risk.
Those with a past history of ulcers or bleeding disorders are also predisposed to bleeding problems. For them, aspirin’s blood-thinning effect can trigger abnormal bleeding or hemorrhage in the digestive tract or brain.
What are the specific new warnings on aspirin labels?
Here are examples of the type of warnings now required on aspirin labels targeting adults ages 60 and over:
- “WARNING: Regular use of aspirin can cause serious bleeding problems, especially in the stomach and brain.”
- “Call your doctor before taking this product on a regular basis if you are 60 or older.”
- “Do not take this product on a regular basis without consulting your doctor if you have a history of stomach ulcers or bleeding problems.”
These alerts are intended to catch the attention of people who are most susceptible to complications and remind them to discuss aspirin use with a healthcare provider first.
Why was this new warning issued on aspirin?
The FDA determined that stronger labeling was needed to better inform the public, and especially higher risk groups, about two particular bleeding risks linked to regular aspirin use:
- Gastrointestinal bleeding: Taking aspirin regularly over time, even at low doses, can cause stomach and intestinal bleeding. This type of bleeding may be silent without clear symptoms.
- Intracranial hemorrhage: Long-term aspirin use increases the risk of serious bleeding strokes, known as hemorrhagic strokes or intracranial hemorrhage. These occur when blood vessels rupture causing bleeding inside the brain.
According to the FDA, the available scientific evidence makes clear that these risks outweigh the benefits of regular aspirin use in people over 60 and those with bleeding issues. Hence, the decision to enhance labeling to caution these groups about potential harms.
What evidence did the FDA review about aspirin’s risks and benefits?
The FDA’s comprehensive review included results from large clinical studies as well as other medical literature examining both the pros and cons of regular aspirin use. Some of the key evidence considered includes:
- A 2020 independent study commissioned by the FDA finding that the bleeding risks with long-term, daily aspirin use clearly increase after age 70.
- Results from three major clinical trials – ASPREE, ASPirin in Reducing Events in the Elderly (ASPREE), Aspirin To Reduce Risk Of Initial Vascular Events (ARRIVE), and ASCEND (A Study of Cardiovascular Events in Diabetes) – which collectively did not show a benefit to regular aspirin use for the primary prevention of heart disease or stroke in people over 60.
- Estimates that adults over 60 represent about 40% of the millions of Americans who regularly take aspirin without a physician’s recommendation.
This body of evidence ultimately led the FDA to update the aspirin warnings to emphasize the bleeding risks and encourage discussions with doctors, especially for higher risk adults over age 60.
What are the signs of internal bleeding linked to aspirin?
While taking aspirin can increase the chance of serious bleeding in the stomach, intestines, and brain, these types of internal bleeding often have no obvious initial symptoms. However, there are some signs of significant blood loss to watch out for, including:
- Feeling lightheaded or dizzy
- Extreme fatigue or weakness
- Skin becoming very pale
- Rapid heartbeat
- Bloody or tar-like stool
- Vomiting blood or coffee ground-like material
- Severe headache or confusion
If you experience any of these warning signs while taking aspirin regularly, seek medical care immediately to check if internal bleeding may be occurring.
Who may still benefit from regular aspirin use?
While the risks often outweigh the benefits for many groups, there are some specific instances where regular aspirin use may still be advised. These include:
- Secondary prevention: People with a history of heart attack or stroke may benefit from ongoing aspirin to prevent recurrence. However, this should only be taken under a doctor’s direction.
- Other heart conditions: For adults with high cardiac risk factors, a physician may recommend daily aspirin to lower the chance of a first heart attack or stroke. This requires an individualized discussion of bleeding risks versus heart benefits.
- During acute cardiac events: Aspirin remains strongly recommended for immediately treating heart attacks and strokes to prevent blood clotting.
For situations like these, a doctor may determine the potential cardiovascular benefits outweigh the bleeding risks. If so, they will provide guidance on the appropriate aspirin dosing and precautions.
Should you stop taking regular aspirin if you are over 60?
The FDA is not advising anyone who is already taking daily aspirin without guidance from their doctor to stop immediately on their own. Sudden discontinuation of aspirin therapy could have negative effects.
Instead, the agency recommends adults over 60 who are regularly using aspirin non-medically should consult their primary care physician. The doctor can conduct an individual assessment of the pros and cons based on the person’s medical history and risk factors.
Some options the physician may consider include:
- Continuing the same aspirin regimen
- Changing the dose or frequency
- Suggesting non-aspirin alternatives like acetaminophen
- Tapering off aspirin use slowly under medical supervision
- Discontinuing aspirin if the risks are deemed too high
Never make aspirin usage decisions on your own without first talking to a doctor. Suddenly stopping daily aspirin therapy that was previously prescribed can trigger rebound effects and complications in some cases.
Are there any other precautions when taking aspirin?
If you do decide to take regular aspirin for any reason, keep these general precautions in mind to use it as safely as possible:
- Take the lowest effective dose to minimize bleeding risks.
- Avoid taking aspirin on an empty stomach to reduce gastric irritation. Take with food or milk.
- Be vigilant for signs of bleeding problems and seek medical attention promptly if they occur.
- Let your healthcare providers know you take daily aspirin before procedures, surgeries, and dental work to manage bleeding risks.
- Consult a doctor before combining aspirin with blood thinners, steroids, or NSAIDs which also thin the blood.
- Do not exceed recommended dosing limits.
Proper precautions can help balance the risks and allow any potential benefits of aspirin to be achieved more safely, if it is recommended for your situation.
Key Takeaways
Here are some of the key points to understand about the FDA’s new warnings on aspirin labels:
- Aspirin now requires enhanced labeling about bleeding risks in adults over 60 and those with a history of ulcers or bleeding disorders.
- Regular aspirin use can lead to gastrointestinal bleeding and hemorrhagic stroke, even at low doses.
- The FDA determined these bleeding hazards outweigh the potential heart benefits of aspirin for many groups.
- Adults over 60 taking aspirin without a doctor’s guidance should consult their physician about continuing or stopping therapy.
- Aspirin may still be appropriate for some people at high cardiac risk. This requires an individual risk-benefit assessment.
- Be aware of bleeding warning signs and take appropriate precautions when using aspirin.
Conclusion
Aspirin remains an extremely common medication for reducing pain, fever, and inflammation. However, its long-term use does come with underappreciated bleeding risks. The FDA’s move to enhance labeling is intended to promote more informed discussions around regular aspirin use, especially for higher risk populations.
Adults over age 60, as well as anyone with increased bleeding susceptibility, should speak with their doctor to determine if the cardiovascular benefits they hope to gain from daily aspirin therapy outweigh the potential harms. By individualizing decision making around aspirin use, patients and doctors can optimize treatment while mitigating risks.