Yesterday the FDA and Bayer Pharmaceutical Corp. announced that Trasylol is being pulled from the U.S. market. This news comes after a Canadian study suggested that it might cause an increased risk of death. The controversial drug is used to treat patients who have an elevated risk of excessive bleeding during heart surgery. The study was discontinued when preliminary results suggested this association. The FDA will need time to review the data from the study before any conclusive ruling can be made on the risk of Trasylol.
The FDA is attempting to allow limited access to the drug as part of a phasing out process. There are very few drugs that can used for persons at risk of excessive bleeding and the FDA is worried that if the drug is immediately yanked there will be an overwhelming demand for alternative medications.
Trasylol’s history demonstrates that once a drug is approved, halting its sales is exceedingly difficult. Experts on advisory panels are often loath to take widely used medicines out of doctors’ hands, even when their safety is uncertain.
The withdrawal of Trasylol seems very much like a preemptive strike by the FDA to make sure that the worst does not happen.
For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.