June 19, 2014
FDA Antidepressant Warnings May Have Backfired, According To New Study
Brett Smith for redOrbit.com - Your Universe Online
“This study is a one of the first to directly measure a health outcome driven by the interaction of public policy and mass media,” said study author Christine Lu, an instructor in population medicine at Harvard Pilgrim Health Care Institute, in a recent statement. “The FDA, the media and physicians need to find better ways to work together to ensure that patients get the medication that they need, while still being protected from potential risks.”
“This is an extraordinarily difficult public health problem, and if we don’t get it right, it can backfire in serious ways,” added co-author Stephen Soumerai, a Harvard Medical School professor of population medicine.
The 2003 analysis that led to the FDA warning found approximately 1 percent of adolescents and young adults on antidepressants experienced an increase in suicidal thoughts. Warnings based on the study became “frightening alarms to clinicians, parents and young people,” the researchers noted.
However, the researchers added, the 2003 study showed a potential increase in suicidal thoughts, not in actually acting on these thoughts. They also said as more young people were being prescribed antidepressants in the years before 2003, suicide attempts were steady.
In the new BMJ study, scientists reviewed claims information for 2000 through 2010 from 11 health plans in the US Mental Health Study Network, which included anonymous patient information organized to assist in sharing and information comparison between health systems. The study considered data on 1.1 million teens, 1.4 million young adults and 5 million adults.
The scientists also examined the rate of nonfatal drug overdoses in the years after the warnings. Overdoses characterize only 40 percent of suicide attempts, but are regarded as the most reliable gauge of trends. The numbers exhibited a constant upswing in suicide attempts over the six years as antidepressant use dropped 20 percent among young people. For instance, in the second year after the FDA warning was applied, overdoses increased 21.7 percent among adolescents and 33.7 percent among young adults.
“There was a lot of concern that drug companies had manipulated data and underplayed adverse effects,” Dr. Gregory K. Fritz, an academic director at Bradley Hospital in Rhode Island, told the Boston Globe. “The FDA at that time was not purely doing science. They were responding to a national anxiety. It really points to the fact that you’ve got to be cautious, and there may be unintended consequences.”
The FDA would later modify the 2003 warning to say that physicians should take into account both the danger of prescribing the medication and the risk of not prescribing the medication, tracking patients for thoughts of suicide and treating them when necessary.
“These drugs can be very effective,” Soumerai said. “The media concentrated more on the relatively small risk than on the significant upside.”