Two Health Advisories Were Issued for Trasylol®
FDA Strengthens Safety Warnings for Trasylol®
WASHINGTON, DC — January 5, 2007 — The Food and Drug Administration (FDA) has revised the labeling and prescription instructions for Trasylol® to warn about potentially life–threatening allergic reactions and the risk of kidney failure. Trasylol® is used to reduce bleeding and is given to patients before they undergo heart surgery.
A “black box” warning, the highest alert level that the FDA imposes short of recalling a drug, now advises that in some cases, even test doses of Trasylol® have caused allergic reactions that proved fatal. The risk of allergic reactions increases if a patient takes Trasylol® after having received another dose within the last year. Therefore, the FDA warns that patients should not be given Trasylol® again if they have already taken the drug within the last 12 months.
The black box warning also instructs that Trasylol® should only by used by patients who are at increased risk for blood loss and blood transfusion and must undergo heart bypass graft surgery and use a heart pump during the bypass operation. Trasylol® should be administered only when the bypass can be started quickly.
Patients who receive Trasylol® run a risk of having kidney failure before or during surgery, according to the FDA. The label notes that these patients may need kidney dialysis.
History of Trasylol® Side Effects
Trasylol® is the brand name for an injectable form of aprotinin, a protein product produced from the lung tissue of cows. It stops or slows certain enzymes that normally promote bleeding. The FDA approved aprotinin in 1993, and Trasylol® in 1998.
In January 2006, a published study of over 4,300 patients found that heart bypass surgery patients who were given Trasylol® doubled their risk of kidney failure requiring dialysis compared to patients who did not take medicines to reduce blood loss (N Engl J Med. 2006 Jan 26; 354(4): 353–65). It also found increased rates of heart attacks and strokes in patients treated with Trasylol®. Another report confirmed that Trasylol® patients had higher rates of kidney problems than those who took alternative drugs before heart surgery to decrease bleeding (Transfusion 2006 Mar; 46(3): 327–38).
The FDA issued a health advisory about Trasylol® in February 2006, but failed to strengthen the safety warnings on Trasylol’s label at that time. Instead, it asked doctors to carefully monitor patients for heart or kidney problems if they were given Trasylol®.
On September 21, 2006, an FDA advisory panel met to reconsider the safety profile of Trasylol®. It was not until a week after the meeting that Bayer, the manufacturer of Trasylol®, released a report to the FDA involving 67,000 patients who underwent coronary artery bypass graft surgery. Those who received Trasylol® were at increased risk for death, kidney failure, congestive heart failure and stroke.
After learning about the Bayer report, the FDA issued another health advisory that summarized prior studies as well as the Bayer statistics about Trasylol®. Many doctors and consumers question how long Bayer knew about the dangers of Trasylol®. As for the FDA, it made the most recent label and prescribing changes for Trasylol® based on the meeting on September 21, 2006, before it knew about the Bayer report. The agency says that it is still reviewing the Bayer report, and may take further action, including additional label changes (FDA News, December 15, 2006).
Your Trasylol® Case
Brayton Purcell is now evaluating cases of Trasylol® users who have suffered kidney failures, congestive heart failures, or strokes. If you or a family member developed these conditions while or after taking Trasylol®, please contact us through this web site or call 1–866–809–5240 toll–free.
