“Inaccuracies may lead drug safety professionals to draw incorrect conclusions, manufacturers may be wrongly forced to suspend and withdraw medications and interventions, health professionals may mistakenly alter their clinical practices, and patients may be denied safe and effective treatments,” Getz said.
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The FDA has the ability to suspend drug sales or withdraw approval for unsafe medications, a tool that might also be deployed when companies fail to report serious side effects in a timely fashion, Dr. Rita Redberg, editor of JAMA Internal Medicine, wrote in an editorial.
Doctors also need to disclose known side effects to patients, a step that’s often skipped when patients are being recruited for trials, a separate study in the journal points out.
About one third of FDA-approved drugs carry a black box warning, highlighting side effects that may be fatal or cause serious illness or disability.
At one medical center, researchers reviewed 57 protocols for studies of drugs carrying black box warnings. They found that for 36 of the studies (63%) patient consent forms didn’t include these warnings.
“Disclosure of risk of harm to human subjects is an essential function of the consent form,” senior study author Dr. Steven Belknap, a researcher at Northwestern University Feinberg School of Medicine, said by email. “We expect our findings will prompt a rapid and comprehensive response at a national level to determine the extent of the problem and to correct erroneous consent forms.”