Trasylol (aprotinin) is an injectable prescription drug which inhibits certain enzymes that increase the risk of bleeding during surgery, and aids the body’s ability to prevent bleeding. Manufactured by Bayer Pharmaceuticals Corporation, the drug is normally given to patients undergoing heart bypass surgery to control blood loss, but has also been used in other surgeries, such as hip replacement surgery. Trasylol is derived from the lung tissue of cattle.
Trasylol NEWS: May 15, 2008.
Bayer AG to remove remaining supplies of its heart-surgery anti-bleeding drug Trasylol from the U.S. market. The Food and Drug Administration said on Wednesday Bayer had notified the agency that it would begin removing remaining Trasylol stock from the U.S. market. Access will be limited to investigational use for certain patients who have no acceptable alternatives, the FDA said.
The FDA “supports Bayer’s decision to completely remove Trasylol from regular use in the U.S. market,” the agency said.
Dr. Wayne Ray and Dr. Michael Stein of Vanderbilt University in Tennessee commented by saying, “Thus, in all likelihood, this is the end of the aprotinin story.”
Bayer said it was removing Trasylol supplies from all countries where it remained in the supply chain, except where local authorities wanted to keep it in the market for special access programs.
The drugmaker “will work with health authorities to determine what impact, if any, the BART data and any other new data will have on the benefit-risk profile of Trasylol,” Bayer spokeswoman Staci Gouveia via email.
Trasylol is prescribed for patients undergoing heart surgery to control blood loss.
Trayslol was approved by the FDA in 1993 to be administered to heart surgery patients to limit bleeding and the need for transfusions.
Side effects commonly associated with Trayslol include difficulty breathing or shortness of breath, fast heart beat, nausea, vomiting, skin rash, irritation, or inflammation, sudden or severe pain in the chest, legs, head, or groin, and swelling of the face, lips, tongue or neck.
60 Minutes does show on Bayer Drug Trasylol.
A renowned medical researcher estimates that 22,000 patients could have been saved if the Food and Drug Administration removed the heart surgery drug Trasylol two years ago.
In a scathing documentary the television show 60 Minutes tells of one researcher’s findings on the Bayer drug Trasylol.
Featured in the TV show is San Francisco medical researcher, Dr. Dennis Mangano who studied the drug use in 5,065 patients in 17 countries. His studies indicated that patients that were given Trasylol had a greater risk for renal (kidney) failure and other complications.
“It showed an important association between Trasylol use and kidney failure requiring dialysis, Mangano tells Pelley, “And it showed a trend toward increased death in hospital in these patients.”
The story goes on to illustrate that Bayer had known the drug was unsafe and did not halt sales. The story also talks about the current role the FDA has in testing these drugs.
The FDA’s History with Trasylol:
In 2006, the FDA issued a Public Health Advisory to warn doctors and patients about the serious risks of Trasylol side effects. An FDA report found the use of Trasylol doubled the risk of kidney failure and liver damage, increased the chance of heart attack or heart failure by 55%, and resulted in a 181% increase in the risk of stroke. Trasylol administration may cause fatal anaphylactic or anaphylactoid reactions. Fatal reactions have occurred with an initial (test) dose as well as with any of the components of the dose regimen. Fatal reactions have also occurred in situations where the initial (test) dose was tolerated.
Trasylol is contraindicated in patients with a known or suspected aprotinin exposure during the last 12 months.
Why was Trasylol approved in 1993?
Clinical studies showed that patients who received Trasylol had less need for blood transfusions and less bleeding than patients who received a placebo. These clinical studies did not detect an increase in the risk for serious side effects.
What should my doctor know before I’m given Trayslol?
Before being administered Trayslol, it is critical to tell your doctor if you:
- Have received previous treatment with aprotinin, as repeat use increases the possibility of having an allergic reaction
- Have an unusual or allergic reaction to aprotinin, other medicines, foods, dyes, or preservatives
- Are pregnant or trying to get pregnant
Have other studies indicated problems with Trasylol?
One other study suggested that Trasylol administration may increase the risk for clot formation within coronary artery bypass grafts. In this study, patients receiving Trasylol were compared with those receiving a placebo. The study reported that patients receiving Trasylol had an increased rate of bypass graft closure.
Based on these reports, why doesn’t the FDA immediately remove Trasylol from the market?
The findings from a New England Journal of Medicine report indicate that Trasylol’s benefits outweigh its risks. But the FDA is re-examining all these findings in light of the NEJM report and other information.
Can I file a lawsuit if I have suffered damages from taking Trasylol?
Possibly. While all medications have certain, anticipated side effects, a drug manufacturer has a duty to inform physicians adequately regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as “product liability.” Depending upon the particular circumstances of your case, damages may include recovery for any of the following:
- Past and future medical expenses
- Past and future pain and suffering
- Lost wages
- Loss of future earning capacity
- Emotional distress
If you or a loved one has experienced any health problems while taking Trasylol, you should contact your doctor immediately. You may also wish to contact an experienced Trasylol lawyer to discuss your legal options. As all legal claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay.