- Drug Safety Report #1: Bayer Failed To Disclose Dangers of Anti-Bleeding Drug
On February 8, 2006, the FDA issued a public health advisory about Trasylol (aprotinin), a drug used to reduce bleeding during heart surgery. Only days earlier, a finding had been reported in The New England Journal of Medicine that Trasylol significantly increased the risk of heart attack, heart failure, stroke, and kidney failure, whereas two older and much less expensive generic anti-bleeding drugs did not.
Seven months later, the FDA revealed that Trasylol’s manufacturer, Bayer A.G., had neglected to disclose the prior existence of a study suggesting that Trasylol caused these same effects. The FDA learned this during a safety review, when a researcher involved in the ongoing Bayer study sent an anonymous tip. In response to inquiries, Bayer said that the nondisclosure was inadvertent -- even though it had testified to an FDA panel about Trasylol’s safety only six days earlier. The FDA immediately advised doctors to limit Trasylol use to patients whose bleeding risk during surgery outweighs the drug’s risks.
This type of report makes one wonder if we can be confident that new drugs really are as safe as purported. Unfortunately, the FDA does not have legal authority to demand that drug manufacturers disclose all of their safety research. Reported: The New England Journal Of Medicine (Volume 354, page 353), 2006 U.S. Food And Drug Administration
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Drug Safety Report #2: FDA Should Get Tougher on Drug Safety, Say Watchdogs
Two government advisory bodies are calling the FDA to task for inadequate oversight of drug safety. When it approves a new drug, FDA requires manufacturers to monitor the general population for unforeseen or rare side effects and problems with the drug. A report by the Office of the Inspector General at the U.S. Department of Health and Human Services cited widespread neglect among drug companies in fulfilling these obligations. As of September 2005, it said, drug companies had not even started 65% of promised post-marketing studies and nearly half missed deadlines for annual status reports.
Unfortunately, the FDA does not have legal authority to fine companies for such failures nor adequate resources to monitor post-marketing studies. The other report (The Future of Drug Safety) is from the Institute of Medicine (IOM), which advises the government on health issues. The IOM called for reforms to improve FDA oversight and enforcement of drug safety. These include beefing up safety research within the FDA; giving the FDA more power to impose fines; mandating five-year safety reviews of new drugs; and restricting consumer-targeted advertising of new drugs for two years, pending results of safety studies. Reported: U.S. Department of Health and Human Services (June 2006), Institute of Medicine (September, 2006)
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