Bayer failed to reveal to regulators the results of a large study suggesting its widely used heart medicine Trasylol might increase the risk of stroke and death in patients, the FDA said.
Even as recently as Sept. 21, when Bayer scientists appeared at a public meeting to discuss the possibility that Trasylol might have serious risks, the drugmaker failed to mention the study or its results, the FDA said.
In a rare move, the agency released an advisory alerting the public of the new
“Trasylol may be associated with higher risk of kidney failure, heart attack and stroke in patients undergoing coronary artery bypass graft surgery,” the advisory said.
The agency however did not change its advice about whether patients should receive the drug. Instead, the agency recommended Trasylol use should be limited to patients in whom the clinical benefit of reduced blood loss outweighs the potential risks. “Physicians should carefully monitor patients for the occurrence of toxicity, particularly to the kidneys, heart, or brain, and promptly report observed adverse event information to FDA's MedWatch program or Bayer,” the agency said.
A top FDA official told The New York Times, the agency learned of the Trasylol study only last Wednesday, after getting a tip from a researcher involved in it. The official insisted on anonymity because of the sensitive nature of the information. In a written statement, Bayer said it “mistakenly did not inform” the FDA of the study.
“This data was not shared immediately with the agency because it was preliminary in
nature,” Bayer said.
A Bayer spokeswoman told The Times the company stands behind the safety of Trasylol which brought in $200 million in global sales last year.
The Bayer study was performed by a contract research organization, The Times reported. It examined hospital records of 67,000 patients, 30,000 of whom received Trasylol. The remaining patients received other drugs. The study concluded that patients given Trasylol were at greater risk.