The FDA data provide an incomplete picture, but the information underscores serious challenges in delivering safe care and reducing waste in the health-care system. A 2006 Institute of Medicine report estimated that 1.5 million preventable adverse drug events occur each year, and the committee said the number may be much higher.
Here are the most common reactions experienced by women, according to the new FDA data:
And the most common adverse reactions for men:
The FDA unveiled a new access project as part of this week’s Health Datapalooza intended to create more transparency and help developers find ways to improve health care. The FDA initiative compiles about 3.5 million adverse drug event reports from patients, medical providers and pharmaceutical firms over the past decade.
However, the disclosures cannot be considered a comprehensive account of drug reactions. There are limitations on what actually gets reported to FDA, and just the existence of a report doesn't necessarily mean a drug actually caused a bad reaction. Still, the complaint database can help detect problems with various drugs.
There are many more reactions listed for women – more than 2 million reaction records compared to less than 1.3 million for men. The women’s records are more likely to list more than one bad reaction to a drug. And almost half of the reported events for women actually came from the patient, while more than 60 percent of reports for men came from care providers, the drug manufacturer or lawyers.
Dr. Michael Carome, director of the health research group at Public Citizen, said the data don't make clear why more adverse events were reported for women. The FDA data, he added, probably undersell how frequently people suffered an adverse reaction to a drug.
"Much of this is voluntary, so there's likely very significant under reporting," Carome said. "There's likely many more adverse events occurring than you get from this database."
The FDA has promised to release more data on adverse drug events, so perhaps there will be some more clarity to come on why there's a stark difference in the reports from men and women.