Trasylol under the Scrutiny of FDA
Heart is one of the most vital and complex organ of the human bodies. Veins and arteries that pump the blood through out the body surround it. Several complications and functional conditions associated with the heart can occur in an individual’s lifetime. Some of these complications can be fatal. In the past few years, there has been rise in the cardiovascular events and cardiac arrest is one of the leading causes of deaths among the patients every year. Women are at an increased risk of developing heart diseases as compared to men.
Trasylol is used for reducing blood loss among the patients undergoing Coronary Artery Bypass Surgery (CABG). Bayer Healthcare, based in Germany manufactures Trasylol. The U.S. Food and Drug Administration approved Trasylol for market use in 1993. Trasylol decreases the requirement for blood transfusion and controls the bleeding among the patients undergoing liver and open-heart surgeries.
Trasylol is the only product used for reducing the need for blood transfusion among the patients undergoing cardiopulmonary bypass (CPB) during coronary artery bypass graft (CABG) surgery.
The American Heart Association defines CABG as a form of heart surgery that bypasses or re – routes the patients blood around blocked arteries to improve oxygen and blood flow to the heart. Doctors perform the surgery when arteries became clogged, subsequently stopping the blood flow to the heart. Loss of blood flow to the heart leads to heart attack or chest pain. In this surgery, healthy veins or arteries from other part of the patients body are re – routed around the blocked arteries. Trasylol is commonly used in CABG surgery as it blocks the enzymes dissolving blood clots, thus increasing the blood flow to the heart.
However, use of Trasylol has been linked to the severe side effects. In February 2006, the Food and Drug Administration along with Bayer Pharmaceuticals issued a “Dear Healthcare Professional” letter to the medical community informing them that they are evaluating the reports and claims published in medical journals about the side effects associated with the use of Trasylol in the patients who have undergone heart surgery.
The New England Journal of Medicine published one such study in January 2006. This study examined 4,374 heart patients scheduled for coronary artery bypass graft surgery. During this study, patients received either drug therapy or no treatment for blood loss. Of these 4,373 patients, 1,295 patients were given Aprotinin, an active ingredient found in Trasylol. Results of this study revealed that the use of Trasylol during heart surgery increases the risk of kidney failure by 2 percent. Additionally, Trasylol was also linked to stroke, myocardial infarction and renal dysfunction.
Bayer denies these allegations and claims that the drug is safe to be used for surgeries. According to FDA, this study is a “complicated analysis based on a large observational database”. Moreover, FDA has alerted the patients and healthcare professional as follows:
“Anaphylactic or anaphylactoid reactions are possible when Trasylol is administered. Hypersensitivity reactions are rare in patients with no prior exposure to Aprotinin. The risk of anaphylaxis is increased in patients who are re-exposed to Aprotinin-containing products. The benefit of Trasylol to patients undergoing primary CABG surgery should be weighed against the risk of anaphylaxis should a second exposure to Aprotinin be required.”
Anaphylactic shock and reactions could occur due to the exposure to blood products, drugs or environmental agents. An anaphylactic reaction is fatal and immediate. Patients having a prior history of eczema, asthma and hay fever are at an increased risk of developing these symptoms. According to the Food Allergy and Anaphylaxis Network, following are the signs and symptoms of anaphylactic reactions:
- Tingling
- Itching
- Hives
- Asthma symptoms
- Difficulty in breathing
- Diarrhea
- Low blood pressure
- Unconsciousness
- Sensation
- Metallic taste in mouth
- Sensation of warmth
- Swelling of the throat and mouth
- Vomiting
- Cramping
FDA continually monitors the side effects of Trasylol. It has issued a Healthcare Advisory to the doctors and patients. FDA has asked the doctors to carefully monitor the patients who have taken Trasylol.
Trasylol Withdrawn due to the Increased risk of death
Due to the ever rising pressure of medical regulation agencies, Bayer, manufacturer of Trasylol declared on November 5, 2007 to withdraw the controversial drug off the shelves. This declaration was followed after a research conducted in Canada showed higher risk of death among the patients using this drug. Bayer AG, a German pharmaceutical firm, manufacturer of the drug still believes that the drug was beneficial. Study conducted by the Ottawa Health Institute was stopped in between as the patients given Trasylol during open valve and heart surgery increased the risk of death to that of the patients given antifibrinolytic drugs.
Antifibrinolytic drugs like Trasylol are used in valve and open heart surgeries as they reduce the breakdown of blood clots formed during surgery, thus preventing blood loss. According to the Food and Drug Administration (FDA) there are few alternatives for the patients undergoing heart surgery. Therefore, FDA has asked Bayer to remove the drug from the market in phases so that there is no shortage of other drugs. So, there will be no absolute Trasylol recall.
In September 2006, Bayer failed to inform FDA about the fatal side effects of Trasylol as compared to other antifibrinolytic drugs. One of the researchers, Dr. Mangano alerted the FDA about the sever side effects of using Trasylol. According to Public Health Advisory Update, issued by FDA on October 3, 2006, that “physicians consider limiting Trasylol use to those situations in which the clinical benefit of reduced blood loss is necessary to medical management and outweighs the potential risks” and cautiously monitor the patients using them. Due to the necessity of such drugs during open valve and heart surgeries, FDA did not declared withdrawal of drug from the market but issued a warning letter highlighting the side effects of the drug.
The trend of potentially hazardous side effects of Trasylol, demonstrates that it is very difficult to remove the drug from the market once it is approved by FDA. Experts at the advisory committee are hesitant to remove widely used drugs and medicines from the doctor’s hand, even when their safety is unsure. Therefore, patients who have been given Trasylol during open heart surgery should contact a doctor. This need for consulting doctor is further more important for the patients who may require Trasylol in the future surgical procedure.
If you believe that you are suffering from the side effects of Trasylol, contact an experienced pharmaceutical lawyer who will assist you in filing a lawsuit against the manufacturer.
Medical Community Astounded by Recent Trasylol Revelations
Recent revelations about the injectable drug Trasylol-Aprotinin put the doctors and medical community into bewilderment. This injectable drug is widely used to stop postoperative bleeding in 60 percent of the liver and heart surgery patients. However, recently it has been linked to severe side effects like encephalopathy, kidney failure, stroke or even death. Bayer AG manufactures this drug and it was approved for the market use in the United States in 1993. Controversy associated to the drug start doing the rounds in January 2006 after the New England Journal of Medicine published a report. According to this report, Trasylol increases the risk of kidney failure by 259 percent among the patients undergone heart surgery.
In an article published in the Washington Post in January 2006, it was declared as one of the safest drug that no longer needed clinical study. The article further stated that the usage of this drug reduces the risk of blood transfusion among the heart surgery patients. Astoundingly, this article mentioned that if the researchers had used the constructive information from the earlier studies or researches they would not have required conducting their own clinical trials.
The above-mentioned information was published in an article January 2, 2006. Problems arise for Trasylol after the publication of an article in the New England Journal of Medicine. Bayer continually denied the results of this study. However, it came under the scrutiny of the U.S. Food and Drug Administration who warned the patients and healthcare professionals about the severe side effects of this drug including stroke, heart attack and life threatening brain disease called encephalopathy.
Though, Bayer has denied these allegations and markets this drug for several other procedures, lawsuits have been filed as more and more patients suffer from the side effect of Trasylol-Aprotinin.
If you believe that you are suffering from the Trasylol-Aprotinin side effects, than immediately consult a doctor to get timely treatment. Thereafter, seek the advice of a pharmaceutical lawyer who will assist you in filing a lawsuit against the manufacturer of the drug. He will tell you whether you are eligible for monetary compensation or not.