Trasylol (Aprotinin injection)
Trasylol (Aprotinin injection) is a blood-clotting medication given to patients during certain types of heart bypass surgery, to reduce bleeding and the need for blood transfusions. Trasylol works by inhibiting certain enzymes that increase the risk of bleeding. Trasylol is manufactured by Bayer, and was approved by the U.S. Food and Drug Administration in 1993.
Trasylol Sales Suspended Worldwide
On November 5, 2007, Trasylol manufacturer Bayer AG announced that it was suspending worldwide sale of the drug until results of a recent drug trial could be properly evaluated. In October 2007, a Canada-based drug study of cardiac surgery patients was halted because Trasylol use appeared to cause increase health risks compared with other anti-bleeding drugs used in the study -- including risk of kidney failure, stroke, and heart attack. (Read the Bayer Press Release).
Trasylol Health Risks - Kidney Failure, Stroke, and Heart Attack
The safety of Trasylol has been under increased scrutiny since two research studies published in January 2006 found that use of Trasylol could cause serious side effects including kidney failure, stroke, and heart attack. A January 26, 2006 report in The New England Journal of Medicine suggests that Trasylol administration may increase the risk for serious side-effects among some patients undergoing coronary artery bypass grafting (CABG). This report describes the occurrence of serious kidney damage, heart attack (myocardial infarction) and stroke among CABG patients receiving Trasylol. More patients receiving Trasylol experienced these events than patients receiving either no medications intended to decrease blood loss, or other medications intended to decrease blood loss. Another study suggested that patients receiving Trasylol may be at higher risk for kidney damage. This report (published January 20, 2006 in the on-line edition of Transfusion) used methods similar to those used in The New England Journal of Medicine study but included a smaller number of patients.
Trasylol and Health Risks - Serious Allergic Reaction
Anaphylactic Reaction is a rare but serious allergic reaction that happens suddenly and can be life threatening. Patients who have had Trasylol in the past have a higher chance for anaphylactic reactions with a new dose of Trasylol.
Trasylol - Advice for Patients
The FDA and Trasylol manufacturer Bayer are continuing to examine the safety and benefits of Trasylol while sale of the drug is suspended. Patients should discuss all major risks for coronary artery bypass grafting (CABG) with their healthcare providers, including the risks for bleeding and the options to lessen the risk for bleeding.
If you are scheduled to have heart surgery, tell your healthcare professional if you:
- Have had Trasylol in the past
- Have had heart surgery
- Are allergic to any medicines
- Have kidney disease
- Are pregnant, trying to become pregnant, or are breast-feeding
- Are taking other medicines. Know the medicines you take. Keep a list of them with you to show your healthcare professional.
Trasylol - Getting Legal Help
While all medications have certain anticipated side effects, a drug manufacturer has a duty to make its products as reasonably safe as possible, and to inform the medical community and the public of known risks associated with its drugs. If a manufacturer fails to do so, it can be held legally responsible if patients are injured as the result of inadequate warnings or the unreasonably dangerous nature of the drug, under a legal theory called "product liability." If you or a loved one have experienced any dangerous symptoms or unusual medical conditions associated with Trasylol, you should first contact your doctor or other healthcare professional. You may also wish to meet with an experienced attorney to discuss your options and to protect your right to a legal remedy for any injuries caused by Trasylol.