On May 14, 2008, Bayer HealthCare Pharmaceuticals Inc. announced it was recalling Trasylol and confirmed that it was pulling its U.S. stock from hospitals and doctors. The announcement was made by the FDA. The reason: severe personal injuries and wrongful deaths.
Last November, in a thoroughly randomized study conduct in Canada, it was found that the drug increased the risk of personal injury and death compared to competing drugs, which are less expensive.
Rather than demand an immediate cessation of use and a recall in response to the November announcement of the Canadian study, the FDA, known for pandering to the drug industry, opted to request Bayer stop marketing the drug, but allowed it to remain on the market and available for use.
The FDA ruling favored Bayer, rather than making patient protection its top priority.
The FDA, the official handmaiden of the drug industry, in its May 14, 2008 announcement provides Bayer with an unbelievable soft landing.
The FDA says it “has not yet received full study data from the study’s researchers at the Ottawa Health Research Institute but supports Bayer’s decision to completely remove Trasylol from regular use in the U.S. market.”
Thanks for protecting patients needing heart bypass surgery by being so pro-active and decisive. If they worked for me, I would fire them.
This announcement is a classic example of a mealy-mouth bureaucracy dominated by pro-industry supplicants protecting drug companies rather than protecting the public with the truth: Trasylol is far more likely to kill patients compared to longstanding comparable and less expensive medications.
The Canadian study will be published on May 21, 2008. That is the reason why Bayer announced the May 14th recall in advance of the expected firestorm of negative publicity when the study is published.
Bayer, which has long marketed “buffered” aspirin, is “buffering” the anticipated adverse press with whitewash.
The FDA and Bayer report that from now on Trasylol may only be used on patients “who have no acceptable alternative therapy.” Doctors who elect to use Trasylol “must verify that the benefits of the drug clearly outweigh the risks for their patients” requiring antifibrinolytic drugs in coronary bypass graft surgery to stop the breakdown of blood clots and reduce blood loss due to bleeding.
The claim that doctors may “elect” to still use Trasylol is nonsense written and promoted by Bayer’s lawyers and consultants.
No surgeon in her or his right mind is using Trasylol when dependable generic anti-bleed drugs are much safer and cheaper.
Trasylol is simply not worth the risk.
And the FDA official announcement is nothing but a cover-up.
Never forget that it is the FDA‘s official position in pending cases before the Supreme Court is that no one injured by a drug should be allowed to sue a drug manufacturer for the harm inflicted upon them. That position is so ludicrous that it prompted immediate hearings in Congress and the drafting of a Patient’s Bill of Rights that will be enacted within a year.
With that in mind, the FDA‘s whitewash of Trasylol is understandable.
Understandable and deplorable.
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