Although Trasylol was withdrawn from the US market in 2007, those who have suffered from its adverse effects may be entitled to compensation. Consult with a New York personal injury lawyer if you or a loved one suffered harm because of this dangerous drug.
Trasylol – also known as Aprotinin – was manufactured by Bayer and approved for use in the US by the Food and Drug Administration (FDA) in 1993. Administered via injection, Trasylol is used for blood-clotting purposes during complicated surgeries, such as heart bypass and liver surgery. By reducing the need for blood transfusions during an operation, it works by inhibiting specific enzymes to minimize blood loss.
In 2006, a study released by the New England Journal of Medicine reported that use of Trasylol has led to an increase of dangerous side effects. Later that year, the FDA revised the labelling for the drug to approve its use for patients who were at a higher risk of blood loss, and included a new warning about potential kidney damage.
Although the FDA kept Trasylol on the market, by 2007, a safety study was prematurely ended because of the link between Trasylol use and death. In November, Bayer suspended worldwide sales. In 2008, the FDA and Bayer announced the removal of any remaining Trasylol supplies; it may currently only be used for research purposes.
The Adverse Effects of Trasylol
Although all medications carry a risk for side effects, the serious and life-threatening risks of Trasylol use outweigh its potential benefits. Since the initial study in 2006, many clinical trials have concluded that Trasylol can cause many health problems, and even death. Some issues resulting from use of Trasylol include:
- Cardiovascular issues – irregular heartbeat, heart attack, congestive heart failure, hemorrhage, myocardial ischemia, pulmonary hypertension, heart block, and pericardial effusion.
- Digestive problems – gastrointestinal hemorrhage, hepatic failure, jaundice, and dyspepsia.
- Blood and lymph complications – thrombosis, cerebral embolism, coagulation disorder, and cerebrovascular accident (stroke).
Other adverse effects can include:
- multi-system organ failure;
- immune system disorder;
- kidney failure and kidney damage;
- severe allergic reactions;
- hyperglycemia; and
- liver failure.
The above list is not exhaustive. There are many other adverse effects involved with the use of Trasylol. Studies have shown that patients who were given repeat dosages of the drug were at a higher risk of side effects than those who were only given one dose. The FDA has stated that these adverse effects will occur within days of receiving Trasylol.
Dangerous Drugs and Manufacturer Liability
When a pharmaceutical manufacturer markets a drug with dangerous side effects that result in injury or death, individuals or families may be able to pursue a product liability claim. Those who were not warned of the dangers of Trasylol have filed a claim for various damages since it was pulled from the market in 2008.
These lawsuits state that Bayer did not exercise an appropriate degree of care when testing the drug. Bayer did not inform doctors, patients, or the FDA of the dangers of Trasylol. Had this drug been withdrawn from the market sooner, the lives of patients could have been saved. If you have suffered any serious side effects, speak with your doctor to ascertain whether you were given Trasylol.
A New York Personal Injury Lawyer Can Help
If you or a loved one has suffered serious harm after using Trasylol, the law offices of Gacovino, Lake & Associates can help with compensation. Located in New York, but serving a nationwide client base, we hold negligent drug manufacturers accountable for your injuries. To learn more about whether you have a viable claim, contact us today at 1-800-246-HURT (4878) to schedule a complimentary consultation.