Study finds drug manufacturers late in reporting adverse events

Ellen Schmidt

University of Minnesota researchers found that some drug manufacturers take too much time to report serious drug side effects to the U.S. Food and Drug Administration, leaving the potential harmful side effects of medications unknown to prescribers and patients.
 
While the FDA allows drug manufacturers a 15-day window for reporting all serious adverse events — like patient deaths or life-threatening side effects — school researchers found manufacturers submit the information late about 10 percent of the time, and patient deaths were usually reported later than other events.
 
Drug manufacturers sometimes delay disclosing information concerning incidents because the time-consuming investigation that follows can take longer than 15 days, 
University Health Policy and Management Associate Professor and study lead Pinar Karaca-Mandic said.
 
“One extreme could be that firms are selectively withholding negative information from the market in order to protect their monopoly or oligopoly profits,” she said.
 
The FDA needs timely information about a medication’s serious side effects to identify potential safety concerns and assess the risks of a drug, FDA spokesman Christopher Kelly said in an email.
 
Drug warning labels, limits on medication doses and removing products from the market could be impacted by tardy reporting of adverse events, the email said.
 
The federally regulated timeframe for reporting negative patient side effects exists to monitor reactions caused by medication, Karaca-Mandic said. She said she thinks drug manufacturers should report an occurrence and update the FDA as an investigation progresses, rather than holding back information past the 15-day mark.
 
The study, which examined more than 1.6 million FDA adverse event reports from January 2004 to June 2014, suggested that the findings may underestimate the number of adverse events that occurred, because drug manufacturers could have classified incidents as less severe than they were.
 
Withdrawing study participants could also lead to underestimating how often an adverse event occurs, said Leigh Turner, University Center for Bioethics associate professor.
 
“One of the tricks of the trade is to withdraw someone from the study but don’t report it as an adverse event,” he said. “In a sense, it’s a way of making adverse events 
disappear.”
 
Turner said because the reporting process is complicated, the FDA must assume manufacturers use their good judgment to honestly disclose incidents, which can lead to underreporting, he said.
 
“If the evidence that has been used to bring drugs to market is skewed or downplaying risks, that’s a dangerous thing because it means that all of us in a sense are vulnerable to underreporting of these risks and inaccurate information,” he said.
 
Karaca-Mandic said she hopes further research on the topic will lead to finding a reason why drug manufacturers hold off when reporting side effects, she said.
 
“We found out what’s going on, and now we’re trying to find out why,” she said.