FDA Warns Heart Surgery Drug Tied to Risks
Posted on: Wednesday, 8 February 2006, 18:00 CST
WASHINGTON - A drug used to prevent blood loss during heart bypass surgery has been linked to higher risks of serious side effects, including kidney problems, heart attacks and strokes, health officials warned doctors and patients Wednesday.
The Food and Drug Administration said it was evaluating the safety of Trasylol, formally known as aprotinin, in light of two studies published in January that link its use to the problems.
The drug's maker, Germany-based Bayer AG, said the drug is safe and effective when used correctly in artery bypass graft surgery patients.
Bayer added in a statement that it will continue working with regulatory authorities "in all countries where Trasylol is marketed to address questions regarding product safety." The company previously said it had contacted officials in the United States, Canada, Australia and Europe.
Trasylol is the only FDA-approved drug to stanch the loss of blood and prevent the need for blood transfusions in surgeries to bypass clogged coronary arteries.
The FDA recommended that doctors monitor patients for toxicity, particularly to the kidneys, heart or central nervous system, following use of the drug. They also should consider limiting the drug's use to cases in which the need to reducing blood loss outweighs any risks.
One of the two studies, published in The New England Journal of Medicine, reported that patients who received Trasylol had higher rates of serious kidney problems, heart attacks and stroke compared with patients who received no treatment or treatment with other drugs to prevent bleeding. The second study, published in Transfusion, reported more cases of decreased kidney function in patients treated with Trasylol compared with those who received another treatment to prevent bleeding.
Doctors in both studies chose which patients to treat with Trasylol, raising the possibility that those patients already were sicker than others in the studies, the FDA said.
The regulatory agency said it expects to have one of its advisory committees discuss the drug's risks and benefits and whether measures need be taken.
The FDA approved Trasylol in 1993. It works by blocking enzymes that dissolve blood clots.
---
On the Net:
Food and Drug Administration: http://www.fda.gov/cder/drug/infopage/aprotinin
Source: Associated Press/AP Online
Related Articles
- FDA Authorizes Investigational New Drug Application for Recombinant Human C1 Inhibitor in Kidney Transplantation
- AMAG Pharmaceuticals, Inc. Submits New Drug Application to FDA for Ferumoxytol in Chronic Kidney Disease Patients
- First Patient Enrolled in RAPID MI-ICE Study Employing InnerCool's Endovascular Temperature Modulation Therapy for Heart Attack
- Northwestern Starts New Heart Attack Study
- Gentium Receives Orphan Drug Designation From FDA for Defibrotide to Prevent Hepatic Veno-Occlusive Disease
- Almost All New Drug Approvals Receive FDA Requests for Post-Marketing Studies
- Infections of Febrile Neutropenic Patients in Malignant Hematological Diseases (Second Study Period)
- Breast Cancer Prevention Study Spotlights Debate Over Drug Trials
- Lowering BP With Medication Provides Unexpected Benefits for Heart Disease Patients With 'Normal' Blood Pressure
 |
 |
User Comments (0)
RSS Feeds