Sign up for our complimentary
weekly e-journal

Main Newsletter
Mastery Series
Therapy Series
 
Bookmark and Share | Print Article | Items for the Week Previous | All Articles This Week | Next
This article originally posted 16 May, 2014 and appeared in  CardiovascularMedicationIssue 729

FDA - Stop Using Aspirin for Patients with No History of Heart Disease

The Food and Drug Administration last week stated that aspirin should not be used for stroke or heart attack prevention in people with no history of heart disease.... 

Advertisement

Although evidence indicates that aspirin's benefits outweigh its bleeding risks for patients with a history of a cardiovascular event, the data do not support the use of the drug for the prevention of first heart attack, the agency said. The FDA released the statement in response to Bayer's request to change its aspirin product labeling.

The use of the medicine raises serious risks of bleeding in the stomach and brain, the statement said. While evidence shows that aspirin's benefits for people who have already had a cardiovascular event outweigh the increased risk of bleeding, the data doesn't support using the drug to help people prevent a first attack.

On May 2, the FDA denied a request from Leverkusen, Germany-based Bayer AG to change the labeling on its packaging to market the product for heart-attack prevention for patients with no history of cardiovascular disease. Aspirin generated 916 million euros ($1.27 billion) in sales for Bayer last year.

Anne Coiley, a spokeswoman for Bayer, said in an e-mail, "Importantly, the ruling does not impact the numerous cardiovascular indications for which aspirin is already approved by the FDA."

Aspirin didn't help prevent heart attacks or strokes in people with a high risk of heart disease yet don't show any symptoms, according to a study published in the Journal of the American Medical Association in 2010. Higher-risk people had a similar number of attacks and strokes as participants taking placebo, the researchers said.

Allen Taylor, professor at Georgetown University School of Medicine and chief of cardiology at MedStar Georgetown University Hospital and MedStar Washington Hospital Center, added that, "It's a useful statement to warn people that aspirin is not a blanket therapy."

Practice Pearls:

  • Start the conversation with your patients and question them about their use of aspirin
  • Many patients are taking the daily aspirin due to the quantity of advertising seen
  • Have the conversation about the use of aspirin and the risk versus benefits

FDA News Release, May 5, 2014

Advertisement


 

Bookmark and Share | Print | Category | Home

This article originally posted 16 May, 2014 and appeared in  CardiovascularMedicationIssue 729

Past five issues: Issue 747 | Diabetes Clinical Mastery Series Issue 206 | SGLT-2 Inhibitors Special Edition September 2014 | Issue 746 | Diabetes Clinical Mastery Series Issue 205 |

2014 Most Popular Articles:

Abbott Announces Approval of Its New Unique Continuous Glucose Monitor
Posted September 05, 2014
Diabetic Neuropathy Improved with Vegan Diet
Posted August 22, 2014
Low Carb Beats Low Fat
Posted September 05, 2014
CDC: 40% of American Adults Will Develop Diabetes
Posted August 22, 2014
Empagliflozin (Jardiance) SGLT-2 Inhibitor Now Available in Pharmacies
Posted August 29, 2014
Lilly's Basal Insulin Peglispro Demonstrated HbA1c Superiority against Lantus
Posted September 05, 2014
Pistachios Associated with an Improved Metabolic Risk Profile in Prediabetes
Posted August 29, 2014
New Ultra-Rapid-Acting Insulin Formulation
Posted August 22, 2014
FDA Approves J&J's Invokamet Combo (SGLT-2 + Metformin)
Posted August 15, 2014
Sensor Implant Measures Blood pH in Type 1 Diabetes
Posted August 29, 2014


Browse by Feature Writer & Article Category.
A. Lee Dellon, MD | Aaron I. Vinik, MD, PhD, FCP, MACP | Beverly Price | Charles W Martin, DD | Derek Lowe, PhD | Dr. Bernstein | Dr. Brian Jakes, Jr. | Dr. Fred Pescatore | Dr. Tom Burke, Ph.D | Eric S. Freedland | Evan D. Rosen | Ginger Kanzer-Lewis | Greg Milliger | Kristina Sandstedt | Laura Plunkett | Leonard Lipson, M.A. | Louis H. Philipson | Maria Emanuel Ryan, DDS, PhD | Marilyn Porter, RD, CDE | Melissa Diane Smith | Michael R. Cohen, RPh, MS, ScD, FASHP | Paul Chous, M.A., OD | Philip A. Wood PhD | R. Keith Campbell, Professor, B.Pharm, MBA, CDE | Sheri R. Colberg PhD | Sherri Shafer | Stanley Schwartz, MD, FACP, FACE | Steve Pohlit | Steven V. Edelman, M.D. | Timothy S. Hollingshead |

Cast Your Vote
Now that once-weekly dulaglutide has been approved, will you be prescribing it?
CME/CE of the Week
Warren Joseph, DPM, FIDSA

Category: Wound Care
Credits: .75



Search Articles On Diabetes In Control