Former FDA Commissioner Says Warnings Inadequate
The former commissioner of the Food and Drug Administration said that the warnings provided to doctors and patients about the risks of were wholly inadequate.
As a part of his testimony in the litigation over the drug, David Kessler, the former head of the FDA under the H.W. Bush and Clinton administrations, said that the drug makers did not disclose bleeding risks identified in clinical trials.
warnings “did not adequately notify physicians that some patients are at higher risk than others,” said Kessler in his testimony.
The lawsuit alleges that an Indiana woman was hospitalized and required two blood transfusions as a result of taking the drug. According to the plaintiff, she was put on a different drug, Eliquis, and suffered no complications.
More than 1,500 other lawsuits are pending over allegations that the drug makers did not provide adequate warnings about the risks of bleeding.
The former Food and Drug Administration commissioner testified that warnings understated the risk of bleeding presented by the drug.
The plaintiff alleges that agency approval of the drug was based on a faulty study that did not take into account the bleeding risk in trial runs in the United States.
Kessler noted in his testimony that globally, results showed that presented a 3.6 percent rate of bleeding; however, the tests run in the United States showed a much higher rate of bleeding events – 8.6 percent.
“When we’re talking about the U.S. and we’re looking at that population, the overall rate is 8.06,” contended the plaintiff’s attorney during Kessler’s testimony. “That’s higher than 3.6, isn’t it?”
The former commissioner noted that “we would all get that math.” Kessler also testified that patients and doctors in the United States should have been made aware of the higher rate in the warning.
“It’s important information to me,” stated the former FDA commissioner. “I would want to know about it. It’s a clinically significant adverse event, it’s a demographic characteristic, and it should be in the label.”
Inadequate warnings have resulted in a flood of litigation over the popular anti-coagulant. According to the lawsuits, Janssen and Bayer, failed to warn patients and doctors about the increased risk of bleeding presented by the drug. Only one year after was approved by the Food and Drug Administration in 2001, more than 1,000 reports of bleeding events and 65 deaths were submitted to the agency.
This failure to warn was exacerbated, allege the lawsuits, by the drug makers’ marketing schemes that touted the drug as a convenient alternative to warfarin. However, studies showed that the blood monitoring and dosage touted by the drug makers as the “ difference” put patients at risk, according to the litigation. The lawsuits allege that drug makers discarded research results that did not support their marketing claims.
If you or a loved one has experienced severe bleeding after taking , contact the experienced attorneys at McDonald Worley. The case review is free.