Stroke is the leading cause of severe disability and the fifth leading cause of death for all Americans. The burden is worse in minority communities. African Americans have twice the risk of stroke as whites. Minorities have higher stroke risks, strokes at an earlier age, and more severe strokes.
This may be because people do not know the warning signs (e.g., sudden numbness, confusion, or loss of balance), or the risk factors that lead to stroke, like high blood pressure, diabetes, and an irregular heart rhythm. Some minority groups also suffer disproportionately because of cultural and language barriers, which can lead to a delay in treatment or not seeking treatment at all.
Although there is broad agreement about the benefits of aspirin use in people who have already had a stroke, there has been debate in the scientific community about the benefits and risk of using aspirin for primary stroke prevention, i.e., in people without a prior stroke. The FDA has not recommended that use.
The FDA recently denied a request submitted by Bayer HealthCare, LLC, requesting a change in the prescribing information for health care professionals for aspirin to allow marketing of the product for prevention of heart attacks in patients with no prior history of cardiovascular disease. After a 2003 advisory committee meeting, the 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). The FDA 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.
To help dispel myths and provide accurate information, the FDA has issued consumer and provider friendly guidance on the appropriate use of aspirin therapy containing the latest evidence on who should and should not use aspirin for stoke prevention. In patients who have never had a stroke, aspirin therapy can increase their risk for bleeding in the stomach and brain, and a reduction in strokes with aspirin has not been established. In patients who have already had an ischemic stroke, which happens when a blood vessel that supplies blood to the brain becomes blocked by a blood clot, aspirin therapy has been shown to decrease the risk of having a subsequent event. In general, the benefits may outweigh the risks for these patients.
Aspirin is readily available in drug stores and grocery stores. Before using it, however, patients should discuss with their healthcare providers whether aspirin therapy is the right course of action for stroke prevention.
In January 2015, the FDA approved Savaysa, a drug used to reduce the risk of stroke in patients with atrial fibrillation (AF), a type of abnormal heart rhythm. This is a blood thinning medication similar to several other recently approved anti-coagulants and an older drug, warfarin. All of these drugs reduce the chance of stroke in patients with this condition by more than 50%. However, for patients with kidneys that work well, Savaysa did not work as well as warfarin.
More than 21,000 people with atrial fibrillation participated in the Savaysa clinical trial. Clinical trial data, which is made available from the “Drug Trials Snapshot,” showed a large stroke reduction and no meaningful differences by sex, race (Whites versus Asians), or age (greater than 75 years) for the drug’s performance or side effects (e.g., major bleeding), a finding that is also true for the other anti-coagulants. Other minority groups were under-represented in this trial, so data are not available for those groups. The Drug Snapshot is part of the FDA’s transparency initiative that displays the clinical trial data analyzed by subgroup (e.g., sex, race, and age). This is an important initiative because it provides information on clinical trial participation among varying groups.
See the FDA Voice Blog Post
See also Medical Law Perspectives, February 2015 Report: Mending a Broken Heart: Malpractice Risks in Diagnosing and Treating Heart Disease
See also Medical Law Perspectives, December 2013 Report: Thicker Than Water: Liability When Blood Clots Cause Injury or Death
See also Medical Law Perspectives, November 2013 Report: Diagnosis and Treatment of Heart Attacks: Liability Issues
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication
See also Medical Law Perspectives, March 2012 Report: Off-Label Use of Prescriptions: When is this Medical Malpractice? Is the Pharmaceutical Company Liable for Overpromotion?